LeukemiaPhase 1NCT01029509
Study to Assess OPB-31121 in Advanced Leukemias or Myelodysplastic Syndromes
A Phase 1 study testing OPB 31121 in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with leukemia or myelodysplastic syndrome (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- OPB 31121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects with a diagnosis of treatment resistant or relapsed AML, ALL, or CLL for whom no standard treatment therapies are expected to result in durable remission. Subjects with advanced MDS should have failed lenalidomide or a hypomethylating agent. Subjects with CLL should have failed or relapsed after prior fludarabine and Campath. Subjects with CML should have previously exhausted standard therapy which provides clinical benefit. In addition, untreated subjects not eligible for standard therapy or unwilling to receive standard therapy with the above diagnosis will be eligible.
- Male and female subjects > / = 18 years of age
- Male and female subjects who are surgically sterile (ie, have undergone orchidectomy or hysterectomy, respectively); female subjects who have been postmenopausal for at least 24 consecutive months; or male and female subjects who agree to remain abstinent or to begin two acceptable methods of birth control from one week prior to drug administration through 30 days (for females) and 90 days (for males) from the last dose of study medication.
- (continued from #3) If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), condom, diaphragm, cervical cap or sponge with spermicide.
- Adequate liver function defined as </= 2.5 * institutional upper limit of normal (ULN), </= 2.5 * institutional ULN for alanine transaminase (ALT), aspartate transaminase, (AST) and bilirubin within normal limits unless Gilbert disease has been documented. .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Show all 15Show fewer
- In the absence of rapidly proliferative disease, a minimum of 2 weeks should elapse since prior standard or experimental therapy. Subjects must have recovered to grade less than or equal to 1 from any prior nonhematologic toxicities associated with any previous treatments. Use of leukopheresis or hydrea up to 48 hrs prior to the start of the study will be allowed in presence of proliferative disease. Use of hydrea will be permitted up to 5 days in each cycle for the control of proliferative disease.
- All eligible subjects must have received prior therapy (including chemotherapy, radiation therapy or surgery) greater than or equal to 2 weeks prior to study entry (Screening) and have recovered to Grade 1 toxicity from any prior non-hematological toxicity and to Grade 2 toxicity from any prior hematological toxicity except for thrombocytopenia defined as Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding following investigator's assessment of causality and positive relationship to study medication before participation in this trial.
- For CLL subjects only, all subjects with Rai Stages III-IV are eligible. For subjects with Rai stage 0-I disease, one or more indications for treatment as defined by the NCI sponsored Working Group must exist: • Massive or progressive splenomegaly; OR • Massive lymph nodes; nodal clusters, or progressive lymphadenopathy; OR • Grade 2 or 3 fatigue; or fever > / = 100.5° F or night sweats for greater than 2 weeks without documented infection; or presence of weight loss > / = 10% over the preceding 6 months;
- (continued from #9) OR • Progressive lymphocytosis with an increase in lymphocyte count of > / = 50% over a 2- month period or an anticipated doubling time of less than 6 months.
- For CML, subjects who have exhausted standard therapy which provides clinical benefit.
- Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study.
- Subjects must have a life expectancy of > 3 months.
- Subjects must have a normal ejection fraction (>/= 50%) as measured by multiple gated acquisition (MUGA) scan.
- Subjects must have a normal serum creatinine (at baseline only) with a measured 24 hour creatinine clearance of > 60 cc/min.
Who cannot join
- Clinically significant condition in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables.
- Subjects with active central nervous system (CNS) involvement by leukemia. Subjects with prior history of CNS disease will qualify if active disease is ruled out by imaging studies or spinal tap
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects having taken an investigational drug or therapy within 14 days prior to dosing.
- Subjects who are pregnant or breast feeding. A negative serum pregnancy test must be confirmed prior to the first dose of study medication for WOCBP.
- Use of CYP3A4-enzyme inhibiting drugs and food; use of CYP3A4-enzyme inducing drugs and food; use of CYP2C9-enzyme inhibiting drugs; and use of CYP2C9 enzyme inducing drugs. Others: propranolol, lidocaine, propafenone, verapamil, nitroglycerin, and midazolam.
- Subjects with history of coagulopathy (or taking anticoagulants) including deep vein thrombosis (DVT)/ PE, unstable angina, myocardial infarction and stroke within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Leukemias or Myelodysplastic Syndromes
The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with leukemia or myelodysplastic syndrome (MDS).
Read the detailed description
The Study Drug:
In studies that have been performed in animals, OPB-31121 has been shown to stop certain changes to proteins in the body. Stopping these changes may have an effect on tumor cells. How OPB-31121 works is not fully known.
Study Groups:
The first 3 participants enrolled in the study will receive the lowest level of OPB-31121. Each additional group of 3 or 4 participants will receive a dose level dependent upon how the previous group responded to the study drug.
You may have up to 13 study "cycles" (about 273 days). During each 28 day study cycle, you will receive the study drug for 21 days and then "rest" (no study drug) for 7 days. The cycle is 28 days, 21 days of drug, 7 days of rest.
Study Drug Administration:
The study drug is a pill that should be taken at the same time each day. You should drink 8 ounces (1 cup) of room temperature, non-carbonated water when you take the study drug.
You will eat a snack or meal within 30 minutes after taking the study drug. You should remain sitting upright or standing for at least 30 minutes after taking the drug.
Study Visits for AML, ALL, or MDS participants:
On Day 1 of Cycle 1, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Women who are able to have children will have a urine pregnancy test.
- Blood (about 6 tablespoons total) will be drawn about 10 times. These blood draws will be for routine tests, heart, thyroid testing, pharmacokinetic (PK) testing, and genotyping. PK testing measures the amount of study drug in the body at different time points. Genotyping tests are tests that look at pieces of your DNA called genes. These tests will look at some specific genes that may predict how your body may break down certain types of drugs. A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.
On Day 2 of Cycle 1, blood (about 2 tablespoons) will be drawn for heart, PK, and biomarker testing.
On Days 8, 15 and 21 of Cycle 1:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Blood (about 2 tablespoons) will be drawn for routine, heart, and thyroid testing.
- Blood (about 6 tablespoons total) will also be drawn for PK testing. Blood will be drawn a total of 10 times, with the last blood draw about 10 hours after you receive the study drug.
- Blood (about 1/2 tablespoon) will be drawn for biomarker testing (Day 21 only).
On Day 22 of Cycle 1, blood (about 1 tablespoon each time) will be drawn 2 times for PK testing.
On Day 23 of Cycle 1, blood (about 1 tablespoon) will be drawn 1 time for PK testing.
On Day 28 of Cycle 1, you will have the following procedures performed:
- You will have an ECG.
- You will have a physical exam, including measurement of your vital signs.
- You will have a bone marrow aspiration sample taken to check the status of the disease. This sample will be taken after you have taken the study drug and only at the end of each odd cycle.
On Day 1 of Cycles 2-13, you will have the following tests and procedures will be performed:
- Blood (about 1-1/2 tablespoons) and urine will be collected for routine, heart, and thyroid tests.
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Women who are able to have children will have a urine pregnancy test.
- On Day 1 of Cycles 2 and 3 only, blood (less than 1 tablespoon) will be drawn for biomarker tests.
- You will have a MUGA scan.
- If your doctor thinks it is needed, you will have a bone marrow aspiration/biopsy.
Study Visits for CLL or CML participants:
On Day 1 of Cycle 1, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Blood (about 8 tablespoons total) will also be drawn a total of 10 times for routine, heart, thyroid, biomarker, genotyping, and PK testing. The last blood draw will be 24 hours after you receive the study drug (Day 2). A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.
- Women who are able to have children will have a urine pregnancy test.
- If your doctor thinks it is needed, you will have a bone marrow biopsy.
On Day 2 of Cycle 1, blood (about 2 tablespoons) will be drawn 24 hours after your study drug dose for heart and PK testing.
On Days 8 and 15 of Cycle 1, blood (about 7 tablespoons) will be drawn for routine and PK testing.
On Days 21 of Cycle 1, you will have an ECG. Blood (about 8 tablespoons in total) will be drawn about 8 times for PK, routine, heart, thyroid, and biomarker testing.
On Days 22 of Cycle 1, blood (about 1 tablespoon each time) will be drawn 2 times for PK testing.
On Day 23 of Cycle 1, blood (about 1 tablespoon) will be drawn 1 time for PK testing.
During Cycles 2-13, blood (about 1 tablespoon) will be drawn every 2 weeks for routine, heart, and thyroid testing.
On Day 1 of Cycles 2-13, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG and MUGA scan.
- Blood (about 2 tablespoons) will be drawn for routine, heart, thyroid, and biomarker tests.
- Women who are able to have children will have a urine pregnancy test.
- During Cycles 2-3 only, blood (about 1 tablespoon) will be drawn for biomarker testing.
End-of-Study Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Blood (about 7 tablespoons) will be drawn for routine, heart, thyroid, and PK tests.
- Urine will be collected for routine tests.
- If you have AML, ALL or MDS, blood (about 1-1/2 tablespoons) will be drawn for biomarker testing.
Follow Up:
Your doctor or other study staff will call you about 30 days after your final visit to see how you have been feeling. The phone call will take about 5-10 minutes.
This is an investigational study. OPB-31121 is not FDA approved or commercially available. At this time, OPB-31121 is only being used in research. Up to 48 patients will take part in this multi-center study.
- Conditions
- Leukemia
- Being tested
- OPB 31121
- Keywords
- Advanced Leukemia, Acute myeloid leukemia, ALL, Chronic myeloid leukemia blast crisis, CMS, Acute lymphocytic leukemia, Chronic lymphocytic leukemia, Myelodysplastic syndromes, MDS, OPB 31121
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB 31121Drug
Starting dose of 200 mg (two 100 mg tablets) twice a day for 21 days followed by 7 days of rest.
| Study group | Role | What they receive |
|---|---|---|
| OPB-31121 | Experimental | OPB-31121 200 mg twice daily for 21 days followed by 7 days of rest Receives: Drug: OPB 31121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD defined as highest dose level at which < 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.
Measured: Assessed at end of 28 day cycle for each dose cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Colloborator-Sponsor decision to terminate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gautam Borthakur, MBBS, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029509
- Sponsor's protocol ID
- 2007-0488
- Status last verified
- Jul 2012
- First submitted
- 8 Dec 2009
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Leukemias or Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01029509
- Acronym / sponsor ID
- 2007-0488
- Conditions
- Leukemia
- Keywords
- Advanced Leukemia, Acute myeloid leukemia, ALL, Chronic myeloid leukemia blast crisis, CMS, Acute lymphocytic leukemia, Chronic lymphocytic leukemia, Myelodysplastic syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Colloborator-Sponsor decision to terminate.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jul 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
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 this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with leukemia or myelodysplastic syndrome (MDS).
Detailed description
The Study Drug:
In studies that have been performed in animals, OPB-31121 has been shown to stop certain changes to proteins in the body. Stopping these changes may have an effect on tumor cells. How OPB-31121 works is not fully known.
Study Groups:
The first 3 participants enrolled in the study will receive the lowest level of OPB-31121. Each additional group of 3 or 4 participants will receive a dose level dependent upon how the previous group responded to the study drug.
You may have up to 13 study "cycles" (about 273 days). During each 28 day study cycle, you will receive the study drug for 21 days and then "rest" (no study drug) for 7 days. The cycle is 28 days, 21 days of drug, 7 days of rest.
Study Drug Administration:
The study drug is a pill that should be taken at the same time each day. You should drink 8 ounces (1 cup) of room temperature, non-carbonated water when you take the study drug.
You will eat a snack or meal within 30 minutes after taking the study drug. You should remain sitting upright or standing for at least 30 minutes after taking the drug.
Study Visits for AML, ALL, or MDS participants:
On Day 1 of Cycle 1, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Women who are able to have children will have a urine pregnancy test.
- Blood (about 6 tablespoons total) will be drawn about 10 times. These blood draws will be for routine tests, heart, thyroid testing, pharmacokinetic (PK) testing, and genotyping. PK testing measures the amount of study drug in the body at different time points. Genotyping tests are tests that look at pieces of your DNA called genes. These tests will look at some specific genes that may predict how your body may break down certain types of drugs. A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.
On Day 2 of Cycle 1, blood (about 2 tablespoons) will be drawn for heart, PK, and biomarker testing.
On Days 8, 15 and 21 of Cycle 1:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Blood (about 2 tablespoons) will be drawn for routine, heart, and thyroid testing.
- Blood (about 6 tablespoons total) will also be drawn for PK testing. Blood will be drawn a total of 10 times, with the last blood draw about 10 hours after you receive the study drug.
- Blood (about 1/2 tablespoon) will be drawn for biomarker testing (Day 21 only).
On Day 22 of Cycle 1, blood (about 1 tablespoon each time) will be drawn 2 times for PK testing.
On Day 23 of Cycle 1, blood (about 1 tablespoon) will be drawn 1 time for PK testing.
On Day 28 of Cycle 1, you will have the following procedures performed:
- You will have an ECG.
- You will have a physical exam, including measurement of your vital signs.
- You will have a bone marrow aspiration sample taken to check the status of the disease. This sample will be taken after you have taken the study drug and only at the end of each odd cycle.
On Day 1 of Cycles 2-13, you will have the following tests and procedures will be performed:
- Blood (about 1-1/2 tablespoons) and urine will be collected for routine, heart, and thyroid tests.
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Women who are able to have children will have a urine pregnancy test.
- On Day 1 of Cycles 2 and 3 only, blood (less than 1 tablespoon) will be drawn for biomarker tests.
- You will have a MUGA scan.
- If your doctor thinks it is needed, you will have a bone marrow aspiration/biopsy.
Study Visits for CLL or CML participants:
On Day 1 of Cycle 1, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Urine will be collected for routine tests.
- Blood (about 8 tablespoons total) will also be drawn a total of 10 times for routine, heart, thyroid, biomarker, genotyping, and PK testing. The last blood draw will be 24 hours after you receive the study drug (Day 2). A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.
- Women who are able to have children will have a urine pregnancy test.
- If your doctor thinks it is needed, you will have a bone marrow biopsy.
On Day 2 of Cycle 1, blood (about 2 tablespoons) will be drawn 24 hours after your study drug dose for heart and PK testing.
On Days 8 and 15 of Cycle 1, blood (about 7 tablespoons) will be drawn for routine and PK testing.
On Days 21 of Cycle 1, you will have an ECG. Blood (about 8 tablespoons in total) will be drawn about 8 times for PK, routine, heart, thyroid, and biomarker testing.
On Days 22 of Cycle 1, blood (about 1 tablespoon each time) will be drawn 2 times for PK testing.
On Day 23 of Cycle 1, blood (about 1 tablespoon) will be drawn 1 time for PK testing.
During Cycles 2-13, blood (about 1 tablespoon) will be drawn every 2 weeks for routine, heart, and thyroid testing.
On Day 1 of Cycles 2-13, you will have the following tests and procedures performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG and MUGA scan.
- Blood (about 2 tablespoons) will be drawn for routine, heart, thyroid, and biomarker tests.
- Women who are able to have children will have a urine pregnancy test.
- During Cycles 2-3 only, blood (about 1 tablespoon) will be drawn for biomarker testing.
End-of-Study Visit:
Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Blood (about 7 tablespoons) will be drawn for routine, heart, thyroid, and PK tests.
- Urine will be collected for routine tests.
- If you have AML, ALL or MDS, blood (about 1-1/2 tablespoons) will be drawn for biomarker testing.
Follow Up:
Your doctor or other study staff will call you about 30 days after your final visit to see how you have been feeling. The phone call will take about 5-10 minutes.
This is an investigational study. OPB-31121 is not FDA approved or commercially available. At this time, OPB-31121 is only being used in research. Up to 48 patients will take part in this multi-center study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPB-31121 | Experimental | Drug: OPB 31121OPB-31121 200 mg twice daily for 21 days followed by 7 days of rest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects with a diagnosis of treatment resistant or relapsed AML, ALL, or CLL for whom no standard treatment therapies are expected to result in durable remission. Subjects with advanced MDS should have failed lenalidomide or a hypomethylating agent. Subjects with CLL should have failed or relapsed after prior fludarabine and Campath. Subjects with CML should have previously exhausted standard therapy which provides clinical benefit. In addition, untreated subjects not eligible for standard therapy or unwilling to receive standard therapy with the above diagnosis will be eligible.
- Male and female subjects > / = 18 years of age
- Male and female subjects who are surgically sterile (ie, have undergone orchidectomy or hysterectomy, respectively); female subjects who have been postmenopausal for at least 24 consecutive months; or male and female subjects who agree to remain abstinent or to begin two acceptable methods of birth control from one week prior to drug administration through 30 days (for females) and 90 days (for males) from the last dose of study medication.
- (continued from #3) If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), condom, diaphragm, cervical cap or sponge with spermicide.
- Adequate liver function defined as </= 2.5 * institutional upper limit of normal (ULN), </= 2.5 * institutional ULN for alanine transaminase (ALT), aspartate transaminase, (AST) and bilirubin within normal limits unless Gilbert disease has been documented. .
Key exclusion criteria (7 listed)
- Clinically significant condition in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables.
- Subjects with active central nervous system (CNS) involvement by leukemia. Subjects with prior history of CNS disease will qualify if active disease is ruled out by imaging studies or spinal tap
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects having taken an investigational drug or therapy within 14 days prior to dosing.
- Subjects who are pregnant or breast feeding. A negative serum pregnancy test must be confirmed prior to the first dose of study medication for WOCBP.
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 |
|---|---|---|
| OPB 31121Starting dose of 200 mg (two 100 mg tablets) twice a day for 21 days followed by 7 days of rest. | Drug | OPB-31121 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Assessed at end of 28 day cycle for each dose cohort
MTD defined as highest dose level at which < 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.
Results and safety
The study was stopped early (reason given: Colloborator-Sponsor decision to terminate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- UT 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.
Gautam Borthakur, MBBS study chair
UT MD 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 study testing OPB 31121 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 15 inclusion and 7 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 23 Jul 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Colloborator-Sponsor decision to terminate.). Results are not available in the source record.
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) (time frame: Assessed at end of 28 day cycle for each dose cohort). 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 23 Jul 2012.