Acute Myelogenous LeukemiaPhase 1NCT00943943
Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
A Phase 1 study testing G-CSF, Plerixafor and Sorafenib in people with Acute Myelogenous Leukemia and 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 learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied. Funding Source - FDA OOPD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Leukemia
- What is being tested?
- G-CSF, Plerixafor and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2010to 23 Mar 2017
- 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
- Patients will be 18 years of age or older.
- Patients must have relapsed/refractory leukemia with FLT3 (ITD) mutations. Patients with AML FLT3 mutations who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible.
- Serum biochemical values with the following limits unless considered due to leukemia: creatinine </= 1.5 mg/dl; total bilirubin </= 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; or transaminases (SGPT) </= 2.5 x upper limit of normal (ULN)
- Able to take oral medication.
- Able to understand and provide signed informed consent.
- Ejection fraction at screening must be >/=50%.
- Performance status < 3, unless directly related to leukemic disease process as determined by the Principal Investigator.
Who cannot join
- Subjects with acute promyelocytic leukemia.
- Patients with absolute blast count > 20 k/uL.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
- Men not willing to maintain adequate contraception with their partner over the entire course of the study.
- Hypertension > 140 mmHg systolic OR > 90 mmHg diastolic with or without antihypertensive therapy.
- Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
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- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or active Hepatitis B or C.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event >/= CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Currently using St. John's Wort or rifampin.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Active clinically serious and uncontrolled infection > CTCAE Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patients currently receiving any other standard or investigational treatment for their hematologic malignancy.
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: G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied.
Funding Source - FDA OOPD
Read the detailed description
The Study Drugs:
Sorafenib is a type of drug called a multikinase inhibitor. It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helping the cells divide and grow, which may block the formation of tumors and cause cell death.
Filgrastim promotes the growth of white blood cells, which help to fight infections.
Plerixafor is designed to help move stem cells from the bone marrow to the blood.
Study Drug Dose Level:
If participant is found to be eligible to take part in this study, they will be assigned to a dose level and schedule of sorafenib based on when they joined this study. Up to 5 dose levels and schedules will be tested. Three (3) participants will be enrolled at each dose level for Phase I of the study. The first group of participants will receive dose level "0" of sorafenib. If unacceptable side effects are seen, a dose lower than level "0" will be tried. If no side effects are seen, the next group of 3 participants will be placed on a higher dose level, called Level "1." Each new group will either receive a higher or lower dose of sorafenib or take it more or less often than the group before it, based on whether intolerable side effects are seen. This will continue until the best tolerable dose and schedule of sorafenib is found. Once the best tolerable dose and/or schedule is found, the last 10 participants will be enrolled and will take sorafenib at that dose and schedule. This last group of 10 is considered the early Phase II part of the study.
Each group will receive the same dose level and schedule of filgrastim and plerixafor.
Study Drug Administration:
Participant will receive filgrastim and plerixafor by injection through a needle under the skin on Day 1 (the day the study starts) and then every other day for a total of 7 doses. The injections will be given in the morning. After day one, the injections may be done at participant's home. Participant's study doctor will meet with them one-on-one to discuss how the drug will be given.
On Day 1, participant will begin taking their dose of sorafenib by mouth every other day, once a day, or twice a day, depending on when they join the study.
- If participant is taking sorafenib every other day, during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections (the next morning) .
- If participant is taking sorafenib every day, they will take it at the same time every morning. The first time participant takes sorafenib during Cycle 1 will be 12 hours after the first filgrastim and plerixafor injections.
- If participant is taking sorafenib twice a day, during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections and then every 12 hours.
Participant will take sorafenib without food, at least 1 hour before or 2 hours after eating. If participant misses a dose, they should not take double the dose next time to make up for the missed dose.
These 28 days are one "study cycle".
Participant is allowed to take hydroxyurea or other treatments to control high white blood cell counts.
Study Drug Diary:
Participant will be given a study drug diary that they will be expected to fill out whenever they take study drugs at home. A staff member will explain to participant how to fill out the diary. The study staff will review the diary with participant at every study visit and they will be given a new diary at the beginning of every cycle they start.
Study Visits:
Every week for the first 6 weeks and then every 4-8 weeks until participant leaves the study, the following tests and procedures will be performed:
- Participant will have a physical exam, including measurement of their weight, and vital signs.
- Participant will have a bone marrow aspiration and biopsy done before treatment starts and once somewhere between day 14 and day 17 after the first Sorafenib administration. Another bone marrow sample will be collected between days 24 and 28.
- If participant continues on study, another bone marrow sample will be collected after the third cycle.
- Blood (about 1 teaspoon) will be drawn every 2-4 days for routine tests while participant is taking the study drugs and once a week on days they are not taking the study drugs Plerixafor and Neupogen.
- During the first week, blood (about 1 teaspoon) will be drawn to check the status of the disease before each dose of the filgrastim and plerixafor combination and again 4 to 8 hours after receiving the study drugs. If participant's doctor feels it is needed, additional blood may be drawn after the 2nd blood draw to check the status of the disease. If participant's doctor feels it is needed, these blood draws may continue after the first week if the disease is not responding.
Length of Study:
Participant may continue taking the study drugs for up to 6 cycles (about 6 months). If participant is in complete remission, partial remission, or complete remission with incomplete platelet count recovery after 6 months with no intolerable side effects, their doctor may discuss continuing on the study with them. Participant will be taken off study if the disease gets worse or intolerable side effects occur.
Follow-up Visits:
If participant is in complete remission, and if their doctor thinks it is in their best interest, they may have follow-up visits about every 3 months until the study closes.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Participant will have a bone marrow biopsy and/or aspirate to check the status of the disease.
End-of-Study Visit:
Participant will have an end-of-study visit about 30 days after their last dose of the study drugs. At this visit, the following tests and procedures will be performed:
- Participant will have a physical exam, including measurement of their weight and vital signs.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- Participant will have a bone marrow aspirate and biopsy to check the status of the disease.
This is an investigational study. Sorafenib is FDA-approved and commercially available for treatment of advanced renal cell cancer (RCC) and hepatocellular cancer (HCC) that cannot be removed by surgery. Its use in patients with AML is investigational.
Plerixafor is FDA-approved and commercially available for use in boosting the number of hematopoietic stem cells (HSC) for stem cell collection and transplants (in combination with filgrastim) in participants with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Its use in participants with AML is investigational.
Filgrastim (NeupogenÒ) is FDA-approved and commercially available for use in boosting white blood cell production in participants with low blood cell counts caused by chemotherapy (nonmyeloid malignancies, acute myeloid leukemia, and bone marrow transplantation), treating severe chronic neutropenia (SCN-low blood counts), and boosting production of hematopoietic progenitor cells in patients undergoing peripheral blood progenitor cell (PBPC) collection.
Up to 28 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Acute Myelogenous Leukemia, Leukemia
- Keywords
- acute myelogenous leukemia, AML, Leukemia, myeloid leukemias, mutated fms-like tyrosine kinase receptor-3, FLT3 Mutations, G-CSF, Granulocyte Colony Stimulating Factor, Filgrastim, Neupogen, Plerixafor, Mobozil, Sorafenib, BAY 43-9006
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called Granulocyte Colony Stimulating Factor, Filgrastim, Neupogen
10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days.
PlerixaforDrug
Also called Mobozil
A fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days.
SorafenibDrug
Also called Nexavar, BAY 43-9006
First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours).
Dose Level 0 = 400 mg orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF and Plerixafor with Sorafenib | Experimental | G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections. Receives: Drug: G-CSF; Drug: Plerixafor; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Sorafenib
MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
Measured: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study start29 Oct 2010
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Genzyme, a Sanofi Company, Amgen, National Cancer Institute (NCI), Georgia Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Michael Andreeff, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943943
- Sponsor's protocol ID
- 2008-0501
- Other IDs
- R01FD003733, R21CA143805, NCI-2009-01512
- Status last verified
- Mar 2017
- First submitted
- 20 Jul 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
- 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 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations
- ClinicalTrials.gov ID
- NCT00943943
- Acronym / sponsor ID
- 2008-0501
- Conditions
- Acute Myelogenous Leukemia, Leukemia
- Keywords
- acute myelogenous leukemia, AML, Leukemia, myeloid leukemias, mutated fms-like tyrosine kinase receptor-3, FLT3 Mutations, G-CSF, Granulocyte Colony Stimulating Factor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer, Genzyme, a Sanofi Company, Amgen, National Cancer Institute (NCI), Georgia Institute of Technology
- Study start
- 29 Oct 2010 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 22 Jul 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 learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied.
Funding Source - FDA OOPD
Detailed description
The Study Drugs:
Sorafenib is a type of drug called a multikinase inhibitor. It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helping the cells divide and grow, which may block the formation of tumors and cause cell death.
Filgrastim promotes the growth of white blood cells, which help to fight infections.
Plerixafor is designed to help move stem cells from the bone marrow to the blood.
Study Drug Dose Level:
If participant is found to be eligible to take part in this study, they will be assigned to a dose level and schedule of sorafenib based on when they joined this study. Up to 5 dose levels and schedules will be tested. Three (3) participants will be enrolled at each dose level for Phase I of the study. The first group of participants will receive dose level "0" of sorafenib. If unacceptable side effects are seen, a dose lower than level "0" will be tried. If no side effects are seen, the next group of 3 participants will be placed on a higher dose level, called Level "1." Each new group will either receive a higher or lower dose of sorafenib or take it more or less often than the group before it, based on whether intolerable side effects are seen. This will continue until the best tolerable dose and schedule of sorafenib is found. Once the best tolerable dose and/or schedule is found, the last 10 participants will be enrolled and will take sorafenib at that dose and schedule. This last group of 10 is considered the early Phase II part of the study.
Each group will receive the same dose level and schedule of filgrastim and plerixafor.
Study Drug Administration:
Participant will receive filgrastim and plerixafor by injection through a needle under the skin on Day 1 (the day the study starts) and then every other day for a total of 7 doses. The injections will be given in the morning. After day one, the injections may be done at participant's home. Participant's study doctor will meet with them one-on-one to discuss how the drug will be given.
On Day 1, participant will begin taking their dose of sorafenib by mouth every other day, once a day, or twice a day, depending on when they join the study.
- If participant is taking sorafenib every other day, during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections (the next morning) .
- If participant is taking sorafenib every day, they will take it at the same time every morning. The first time participant takes sorafenib during Cycle 1 will be 12 hours after the first filgrastim and plerixafor injections.
- If participant is taking sorafenib twice a day, during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections and then every 12 hours.
Participant will take sorafenib without food, at least 1 hour before or 2 hours after eating. If participant misses a dose, they should not take double the dose next time to make up for the missed dose.
These 28 days are one "study cycle".
Participant is allowed to take hydroxyurea or other treatments to control high white blood cell counts.
Study Drug Diary:
Participant will be given a study drug diary that they will be expected to fill out whenever they take study drugs at home. A staff member will explain to participant how to fill out the diary. The study staff will review the diary with participant at every study visit and they will be given a new diary at the beginning of every cycle they start.
Study Visits:
Every week for the first 6 weeks and then every 4-8 weeks until participant leaves the study, the following tests and procedures will be performed:
- Participant will have a physical exam, including measurement of their weight, and vital signs.
- Participant will have a bone marrow aspiration and biopsy done before treatment starts and once somewhere between day 14 and day 17 after the first Sorafenib administration. Another bone marrow sample will be collected between days 24 and 28.
- If participant continues on study, another bone marrow sample will be collected after the third cycle.
- Blood (about 1 teaspoon) will be drawn every 2-4 days for routine tests while participant is taking the study drugs and once a week on days they are not taking the study drugs Plerixafor and Neupogen.
- During the first week, blood (about 1 teaspoon) will be drawn to check the status of the disease before each dose of the filgrastim and plerixafor combination and again 4 to 8 hours after receiving the study drugs. If participant's doctor feels it is needed, additional blood may be drawn after the 2nd blood draw to check the status of the disease. If participant's doctor feels it is needed, these blood draws may continue after the first week if the disease is not responding.
Length of Study:
Participant may continue taking the study drugs for up to 6 cycles (about 6 months). If participant is in complete remission, partial remission, or complete remission with incomplete platelet count recovery after 6 months with no intolerable side effects, their doctor may discuss continuing on the study with them. Participant will be taken off study if the disease gets worse or intolerable side effects occur.
Follow-up Visits:
If participant is in complete remission, and if their doctor thinks it is in their best interest, they may have follow-up visits about every 3 months until the study closes.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Participant will have a bone marrow biopsy and/or aspirate to check the status of the disease.
End-of-Study Visit:
Participant will have an end-of-study visit about 30 days after their last dose of the study drugs. At this visit, the following tests and procedures will be performed:
- Participant will have a physical exam, including measurement of their weight and vital signs.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- Participant will have a bone marrow aspirate and biopsy to check the status of the disease.
This is an investigational study. Sorafenib is FDA-approved and commercially available for treatment of advanced renal cell cancer (RCC) and hepatocellular cancer (HCC) that cannot be removed by surgery. Its use in patients with AML is investigational.
Plerixafor is FDA-approved and commercially available for use in boosting the number of hematopoietic stem cells (HSC) for stem cell collection and transplants (in combination with filgrastim) in participants with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Its use in participants with AML is investigational.
Filgrastim (NeupogenÒ) is FDA-approved and commercially available for use in boosting white blood cell production in participants with low blood cell counts caused by chemotherapy (nonmyeloid malignancies, acute myeloid leukemia, and bone marrow transplantation), treating severe chronic neutropenia (SCN-low blood counts), and boosting production of hematopoietic progenitor cells in patients undergoing peripheral blood progenitor cell (PBPC) collection.
Up to 28 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-CSF and Plerixafor with Sorafenib | Experimental | Drug: G-CSF, Drug: Plerixafor, Drug: SorafenibG-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients will be 18 years of age or older.
- Patients must have relapsed/refractory leukemia with FLT3 (ITD) mutations. Patients with AML FLT3 mutations who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible.
- Serum biochemical values with the following limits unless considered due to leukemia: creatinine </= 1.5 mg/dl; total bilirubin </= 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; or transaminases (SGPT) </= 2.5 x upper limit of normal (ULN)
- Able to take oral medication.
- Able to understand and provide signed informed consent.
Key exclusion criteria (17 listed)
- Subjects with acute promyelocytic leukemia.
- Patients with absolute blast count > 20 k/uL.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
- Men not willing to maintain adequate contraception with their partner over the entire course of the study.
- Hypertension > 140 mmHg systolic OR > 90 mmHg diastolic with or without antihypertensive therapy.
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 |
|---|---|---|
| G-CSFAlso: Granulocyte Colony Stimulating Factor, Filgrastim, Neupogen10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days. | Drug | G-CSF and Plerixafor with Sorafenib |
| PlerixaforAlso: MobozilA fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days. | Drug | G-CSF and Plerixafor with Sorafenib |
| SorafenibAlso: Nexavar, BAY 43-9006First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours). Dose Level 0 = 400 mg orally twice daily. | Drug | G-CSF and Plerixafor with Sorafenib |
Primary outcome
Maximum Tolerated Dose (MTD) of Sorafenib
Time frame: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles)
MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- 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.
Michael Andreeff, MD, PhD 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 study testing G-CSF, Plerixafor and Sorafenib in people with Acute Myelogenous Leukemia and 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 29 Mar 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Sorafenib (time frame: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles)). 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 29 Mar 2017.