LeukemiaPhase 1/2NCT02089230
MEK Inhibitor 162 Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Poor Prognosis, Not Suitable for or Unwilling to Receive Standard Therapy
A Phase 1/2 study testing MEK 162 in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of MEK162 that can be given to patients with advanced leukemia. This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- MEK 162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2014to 5 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHASE I -- a. Primary or secondary AML according to World Health Organization (WHO) classification, with relapsed or refractory disease or newly diagnosed older subjects (greater than or equal to 65 years of age), not candidates for intensive chemotherapy; b. Subjects with MDS, International Prognostic Scoring System (IPSS) Int-2 or high risk (RAEB-2 only, i.e. greater than or equal to 10% blast) who are resistant or intolerant to standard treatment and are not candidates for transplantation; c. Subjects with ALL, relapsed, refractory or intolerant to standard treatment and for whom no effective treatment options are available.
- Age greater or equal to 18 years.
- Patients should be willing and able to give informed consent.
- Eastern Cooperative Group (ECOG) PS less than or equal to 2.
- PHASE II -- Patients aged 60 and older with newly diagnosed primary or secondary AML according to WHO classification, without any prior therapy for AML with the exception of (a) emergency Leukapheresis and (b) emergency treatment for hyperleukocytosis with hydroxyurea that is allowed until 24 hours before start of the trial treatment. Note: Prior therapy for preexisting hematological condition e.g. MDS or Myeloproliferative Disorder (MPD), including but not limited to hypomethylating agents is allowed until at least 2 weeks have elapsed from completion of that agent before the first dose of MEK 162.
- Patients must meet at least one of the following conditions: a. Age greater than or equal to 75 years; b. Age greater or equal to 60 and less than 75 years with at least one of the following poor prognostic factors: i. Secondary AML, as determined by known and documented exposure to chemotherapy or radiation therapy; ii. antecedent history of MDS or myeloproliferative disorder according to WHO criteria for at least 3 months prior to trial entry; iii. unfavorable cytogenetic abnormalities including chromosome 5 and 7 as well as complex; iv. ECOG Performance status 2. (Phase II ONLY)
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- Patients are willing and able to give informed consent. (Phase II only)
- Only patients with mutated RAS (KRAS and NRAS) mutations are eligible to participate. (Phase II only)
- Adequate cardiac function defined as: --left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram; -- QTcF interval less than or equal to 480 ms. (Phase II only)
Who cannot join
- PHASE I and II -- Administration of any antineoplastic therapy within at least 4 weeks (cytotoxic chemotherapy) or 2 weeks (biological and targeted therapy; hypomethylating agents are considered to be biological therapy) of that therapy of the first MEK 162/MEK 162 dose; except the use of hydroxyurea which can be administered up to 5 g/day up to 24 hours before the initiation of the study drug.
- Patients should not have received an investigational agent for at least 2 weeks prior to the first study drug dose.
- Clinical evidence of active Central Nervous System (CNS) leukemia requiring active therapy; prior CNS leukemia well-controlled by ongoing therapy is allowed.
- Active and uncontrolled infection including but not limited to known infection with HIV, active hepatitis B, or hepatitis C.
- Major surgery within two weeks prior to trial entry.
- Liver function tests above the following limits at the screening: total bilirubin > 1.5 x Upper Limit of Normal (ULN) unless related to Gilbert's syndrome or hemolysis, AST and/or ALT > 2.5 X ULN, or for subjects with liver involvement Aspartate Aminotransferase (AST) and/or Alanine transaminase (ALT) > 5 x ULN.
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- Serum creatinine > 1.5 x ULN and/or Creatinine Clearance (CrCl) < 30 mL/min at screening (calculation according to Cockcroft \& Gault formula).
- Pregnant or nursing (lactating) women;
- Female patients of childbearing potential and male patients with partners of childbearing potential who are not willing ot use highly effective methods of contraception throughout the study and for 1 month after study drug discontinuation. Highly effective contraception methods include: Total abstinence; or Male or female sterilization; **Combination of any two of the following (a+b or a+c or b+c); a. Use of oral, injected, or implanted hormonal methods of contraception; b. Placement of an intrauterine device (IUD) or intrauterine system (IUS); c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- Female patients with reproductive potential who do not have a negative blood or urine pregnancy test at screening;
- History of significant difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
- Has significant cardiac conduction abnormalities and/ or pacemaker or any of the following criteria: -- History of acute coronary syndromes (including myocardial infarction, unstable angina, Coronary Artery Bypass Grafting (CABG), coronary angioplasty, or stenting) <6 months prior to screening, --Symptomatic chronic heart failure; evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities < 6 months prior to screening --Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg (average of 3 consecutive readings)
- History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO).
- Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, history of hyperviscosity or hypercoagulability syndromes).
- Subjects with active other tumors, except early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN).
- Patients who have neuromuscular disorders that are associated with elevated Creatinine Kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment. NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment.
- Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Trial of MEK Inhibitor MEK162 in Patients With Relapsed and or Refractory Acute Myeloid Leukemia and Patients With Poor Prognosis Acute Myeloid Leukemia Not Suitable for or Unwilling to Receive Standard Therapy
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of MEK162 that can be given to patients with advanced leukemia.
This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Read more
Up to 57 patients total will take part in both phases of this study . All will be enrolled at MD Anderson.
The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to control AML in older patients with advanced leukemia. The safety of this drug will also be studied.
This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 57 patients total will take part in both phases of this study. All will be enrolled at MD Anderson.
Read the detailed description
Phase I:
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of 3-6 participants will be enrolled in Phase 1 of the study.
If you are enrolled in Phase 1, the dose of MEK162 you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of MEK162. The second group will receive a higher dose of MEK162 than the group before it, if no intolerable side effects were seen. This is designed to find the highest tolerable dose of MEK 162.
Participants in Phase 2 will then receive the highest tolerated dose that was found in Phase 1.
Study Drug Administration:
You will take MEK162 tablets by mouth 2 times a day (about 12 hours apart) every day with a full cup of water.
There are 4 weeks in each study cycle.
Study Visits:
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
On Days 4 and 8 of Cycle 1, blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
Sometime during Days 13-27 of each cycle and again on Day 28 of Cycles 2 and beyond, the study staff will call you and ask about any drugs you may be taking and any side effects you may be having. The calls should last less than 10 minutes each time.
On Day 28 of Cycle 1, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker and cytogenetic testing. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
You will have an EKG and either an ECHO or MUGA scan to check your heart function.
On Day 1 of Cycle 2 and beyond:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
- Urine will be collected for routine tests.
- You will have an eye exam by an eye doctor.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On visits when you have blood sugar testing, you should fast for at least 8 hours before the blood draw.
On visits when you have urine collected, you will be given containers to collect your urine over 24 hours if the doctor thinks it is needed.
If it is more convenient to you, you may be able to have some of your blood draws done away from MD Anderson. The study staff will discuss this with you.
Every two or three months during your treatment, you will have an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan to check your heart function.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
After your last dose of study drug:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests
- If the doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker, PD, and/or cytogenetic testing. If you have already had a bone marrow aspirate and/or biopsy recently and your doctor thinks repeating it is not needed, leftover bone marrow will be used for these tests. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
- You will have an EKG.
Phase II:
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 42 participants will be enrolled in Phase 2 of the study.
Participants in Phase 1 were given a dose of MEK162 based on when they joined the study. Groups of participants were given different dose levels until the highest tolerable dose of MEK162 was found.
If you are enrolled in Phase 2, you will receive MEK162 at the highest dose that was tolerated in Phase 1.
Study Drug Administration:
You will take MEK162 tablets by mouth 2 times a day (about 12 hours apart) every day with a full cup of water.
There are 4 weeks in each study cycle.
Study Visits:
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
On Days 4 and 8 of Cycle 1, blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
Sometime during Days 13-27 of each cycle and again on Day 28 of Cycles 2 and beyond, the study staff will call you and ask about any drugs you may be taking and any side effects you may be having. The calls should last less than 10 minutes each time.
On Day 28 of Cycle 1, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker and cytogenetic testing. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
You will have an EKG and either an ECHO or MUGA scan to check your heart function.
On Day 1 of Cycle 2 and beyond:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
- Urine will be collected for routine tests.
- You will have an eye exam by an eye doctor.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On visits when you have blood sugar testing, you should fast for at least 8 hours before the blood draw.
On visits when you have urine collected, you will be given containers to collect your urine over 24 hours if the doctor thinks it is needed.
If it is more convenient to you, you may be able to have some of your blood draws done away from MD Anderson. The study staff will discuss this with you.
Every two or three months during your treatment, you will have an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan to check your heart function.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
After your last dose of study drug:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests
- If the doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker, PD, and/or cytogenetic testing. If you have already had a bone marrow aspirate and/or biopsy recently and your doctor thinks repeating it is not needed, leftover bone marrow will be used for these tests. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
- You will have an EKG.
- Conditions
- Leukemia
- Being tested
- MEK 162
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, Advanced leukemias, Myelodysplastic syndrome, MDS, Acute lymphoblastic leukemia, ALL, Relapsed, Refractory, MEK 162
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEK 162Drug
Phase I Starting Dose of MEK 162: 15 mg by mouth twice a day in a 28 day cycle.
Phase II Starting Dose of MEK 162: Maximum tolerated dose from Phase I.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Cohort 1 - MEK 162 | Experimental | Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle. Receives: Drug: MEK 162 |
| Phase I Cohort 2 - MEK 162 | Experimental | Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle. Receives: Drug: MEK 162 |
| Phase II Cohort 3 - MDK 162 | Experimental | Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle. Receives: Drug: MEK 162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of MEK 162 in Participants With Advanced Leukemias
Maximum tolerated dose is the highest dose level in which <2 patients of 6 develop dose limiting toxicity (DLT).
Measured: 28 days
Secondary outcomes (1)
Number of Participants With a Response
Response is Complete Remission (CR) or CR with incomplete blood count recovery (CRi) according to International Working Group (IWG) consensus criteria for treatment response in Acute Myeloid Leukemia (AML) (modified): Morphological Complete Remission (CR): Normalization of the peripheral blood absolute neutrophil count > 1.0x109/L, platelets > than 100x109/L no residual evidence of extramedullary disease and bone marrow aspirate with ≤ 5% blasts, no blasts with Auer rods (AML only); and Morphological Complete Remission with incomplete blood count recovery (CRi): Same as CR but without normalization of the peripheral blood absolute neutrophil and platelet count.
Measured: Assessed after one 28-day cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start27 Aug 2014
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Why it stopped: The trial was terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Array BioPharma
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi-Kashani, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089230
- Sponsor's protocol ID
- 2013-0116
- Other IDs
- NCI-2014-01518
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2014
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of MEK Inhibitor MEK162 in Patients With Relapsed and or Refractory Acute Myeloid Leukemia and Patients With Poor Prognosis Acute Myeloid Leukemia Not Suitable for or Unwilling to Receive Standard Therapy
- ClinicalTrials.gov ID
- NCT02089230
- Acronym / sponsor ID
- 2013-0116
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, Advanced leukemias, Myelodysplastic syndrome, MDS, Acute lymphoblastic leukemia, ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated due to slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Array BioPharma
- Study start
- 27 Aug 2014 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of MEK162 that can be given to patients with advanced leukemia.
This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 57 patients total will take part in both phases of this study . All will be enrolled at MD Anderson.
The goal of Phase 2 of this clinical research study is to learn if MEK162 can help to control AML in older patients with advanced leukemia. The safety of this drug will also be studied.
This is an investigational study. MEK162 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 57 patients total will take part in both phases of this study. All will be enrolled at MD Anderson.
Detailed description
Phase I:
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of 3-6 participants will be enrolled in Phase 1 of the study.
If you are enrolled in Phase 1, the dose of MEK162 you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of MEK162. The second group will receive a higher dose of MEK162 than the group before it, if no intolerable side effects were seen. This is designed to find the highest tolerable dose of MEK 162.
Participants in Phase 2 will then receive the highest tolerated dose that was found in Phase 1.
Study Drug Administration:
You will take MEK162 tablets by mouth 2 times a day (about 12 hours apart) every day with a full cup of water.
There are 4 weeks in each study cycle.
Study Visits:
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
On Days 4 and 8 of Cycle 1, blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
Sometime during Days 13-27 of each cycle and again on Day 28 of Cycles 2 and beyond, the study staff will call you and ask about any drugs you may be taking and any side effects you may be having. The calls should last less than 10 minutes each time.
On Day 28 of Cycle 1, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker and cytogenetic testing. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
You will have an EKG and either an ECHO or MUGA scan to check your heart function.
On Day 1 of Cycle 2 and beyond:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
- Urine will be collected for routine tests.
- You will have an eye exam by an eye doctor.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On visits when you have blood sugar testing, you should fast for at least 8 hours before the blood draw.
On visits when you have urine collected, you will be given containers to collect your urine over 24 hours if the doctor thinks it is needed.
If it is more convenient to you, you may be able to have some of your blood draws done away from MD Anderson. The study staff will discuss this with you.
Every two or three months during your treatment, you will have an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan to check your heart function.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
After your last dose of study drug:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests
- If the doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker, PD, and/or cytogenetic testing. If you have already had a bone marrow aspirate and/or biopsy recently and your doctor thinks repeating it is not needed, leftover bone marrow will be used for these tests. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
- You will have an EKG.
Phase II:
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 42 participants will be enrolled in Phase 2 of the study.
Participants in Phase 1 were given a dose of MEK162 based on when they joined the study. Groups of participants were given different dose levels until the highest tolerable dose of MEK162 was found.
If you are enrolled in Phase 2, you will receive MEK162 at the highest dose that was tolerated in Phase 1.
Study Drug Administration:
You will take MEK162 tablets by mouth 2 times a day (about 12 hours apart) every day with a full cup of water.
There are 4 weeks in each study cycle.
Study Visits:
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
On Days 4 and 8 of Cycle 1, blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
Sometime during Days 13-27 of each cycle and again on Day 28 of Cycles 2 and beyond, the study staff will call you and ask about any drugs you may be taking and any side effects you may be having. The calls should last less than 10 minutes each time.
On Day 28 of Cycle 1, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker and cytogenetic testing. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
You will have an EKG and either an ECHO or MUGA scan to check your heart function.
On Day 1 of Cycle 2 and beyond:
- You will have a physical exam.
- Blood (about 4 teaspoons) will be drawn for routine tests and blood sugar testing.
- Urine will be collected for routine tests.
- You will have an eye exam by an eye doctor.
- If you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
On visits when you have blood sugar testing, you should fast for at least 8 hours before the blood draw.
On visits when you have urine collected, you will be given containers to collect your urine over 24 hours if the doctor thinks it is needed.
If it is more convenient to you, you may be able to have some of your blood draws done away from MD Anderson. The study staff will discuss this with you.
Every two or three months during your treatment, you will have an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan to check your heart function.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
After your last dose of study drug:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests
- If the doctor thinks it is needed, you will have a bone marrow aspirate and/or biopsy to check the status of the disease and for biomarker, PD, and/or cytogenetic testing. If you have already had a bone marrow aspirate and/or biopsy recently and your doctor thinks repeating it is not needed, leftover bone marrow will be used for these tests. If bone marrow cannot be collected, blood (about 1-2 teaspoons) will be drawn for these tests.
- You will have an EKG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I Cohort 1 - MEK 162 | Experimental | Drug: MEK 162Phase I Starting Dose of MEK 162: 30 mg by mouth twice a day in a 28 day cycle. |
| Phase I Cohort 2 - MEK 162 | Experimental | Drug: MEK 162Phase I Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle. |
| Phase II Cohort 3 - MDK 162 | Experimental | Drug: MEK 162Phase II Starting Dose of MEK 162: 45 mg by mouth twice a day in a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PHASE I -- a. Primary or secondary AML according to World Health Organization (WHO) classification, with relapsed or refractory disease or newly diagnosed older subjects (greater than or equal to 65 years of age), not candidates for intensive chemotherapy; b. Subjects with MDS, International Prognostic Scoring System (IPSS) Int-2 or high risk (RAEB-2 only, i.e. greater than or equal to 10% blast) who are resistant or intolerant to standard treatment and are not candidates for transplantation; c. Subjects with ALL, relapsed, refractory or intolerant to standard treatment and for whom no effective treatment options are available.
- Age greater or equal to 18 years.
- Patients should be willing and able to give informed consent.
- Eastern Cooperative Group (ECOG) PS less than or equal to 2.
- PHASE II -- Patients aged 60 and older with newly diagnosed primary or secondary AML according to WHO classification, without any prior therapy for AML with the exception of (a) emergency Leukapheresis and (b) emergency treatment for hyperleukocytosis with hydroxyurea that is allowed until 24 hours before start of the trial treatment. Note: Prior therapy for preexisting hematological condition e.g. MDS or Myeloproliferative Disorder (MPD), including but not limited to hypomethylating agents is allowed until at least 2 weeks have elapsed from completion of that agent before the first dose of MEK 162.
Key exclusion criteria (18 listed)
- PHASE I and II -- Administration of any antineoplastic therapy within at least 4 weeks (cytotoxic chemotherapy) or 2 weeks (biological and targeted therapy; hypomethylating agents are considered to be biological therapy) of that therapy of the first MEK 162/MEK 162 dose; except the use of hydroxyurea which can be administered up to 5 g/day up to 24 hours before the initiation of the study drug.
- Patients should not have received an investigational agent for at least 2 weeks prior to the first study drug dose.
- Clinical evidence of active Central Nervous System (CNS) leukemia requiring active therapy; prior CNS leukemia well-controlled by ongoing therapy is allowed.
- Active and uncontrolled infection including but not limited to known infection with HIV, active hepatitis B, or hepatitis C.
- Major surgery within two weeks prior to trial entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEK 162Phase I Starting Dose of MEK 162: 15 mg by mouth twice a day in a 28 day cycle. Phase II Starting Dose of MEK 162: Maximum tolerated dose from Phase I. | Drug | Phase I Cohort 1 - MEK 162, Phase I Cohort 2 - MEK 162, Phase II Cohort 3 - MDK 162 |
Primary outcome
Maximum Tolerated Dose (MTD) of MEK 162 in Participants With Advanced Leukemias
Time frame: 28 days
Maximum tolerated dose is the highest dose level in which <2 patients of 6 develop dose limiting toxicity (DLT).
1 secondary outcome
Number of Participants With a Response
Time frame: Assessed after one 28-day cycle of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhad Ravandi-Kashani, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEK 162 in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of MEK 162 in Participants With Advanced Leukemias (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.