Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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
Full 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.
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:
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.
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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
33 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal