Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02829840
Status:
WITHDRAWN
Last Update Posted:
2017-06-02
First Post:
2016-07-05
Brief Title:
Dose-Escalation Study of Ponatinib a FLT3 Inhibitor With and Without Combination of 5-Azacytidine in Patients With FLT3-Mutated Acute Myeloid Leukemia AML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Dose-Escalation Study of Ponatinib a FLT3 Inhibitor With and Without Combination of 5-Azacytidine in Patients With FLT3-Mutated Acute Myeloid Leukemia AML
Status:
WITHDRAWN
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of Part 1 of this clinical research study is to learn if ponatinib alone can help to control FLT3-mutated AML or FLT3-mutated high-risk MDS The safety of this drug will also be studied
The goal of Part 2 of this clinical research study is to find the highest tolerable dose of ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can help to control FLT3-mutated AML or FLT3-mutated high-risk MDS The safety of this combination will also be studied
The goal of Part 2 of this clinical research study is to find the highest tolerable dose of ponatinib in combination with 5-azacytidine and to learn if the highest dose level found can help to control FLT3-mutated AML or FLT3-mutated high-risk MDS The safety of this combination will also be studied
Detailed Description:
Study Groups
If participant is found to be eligible to take part in this study they will be assigned to either Part 1 or Part 2 based on when they join this study
If participant is enrolled in Part 1 they will receive ponatinib alone for the first cycle If the doctor thinks it is needed the dose level may be increased If the disease does not respond to ponatinib alone participant will continue on to Part 2 of this study
Part 2 of this clinical research study will have 2 phases Phase 1 dose escalation and Phase 2 dose expansion
In Part 2 participant will be assigned to a study group based on when they join this study Up to 3 groups of 30 participants will be enrolled in Phase 1 of Part 2 and up to 60 participants will be enrolled in Phase 2
If participant is enrolled in Phase 1 the dose of ponatinib they receive will depend on when they join this study The first group of participants will receive the lowest dose level of ponatinib Each new group will receive a higher dose of ponatinib than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of ponatinib is found
If participant is enrolled in Phase 2 they will receive ponatinib at the highest dose that was tolerated in Phase 1
All participants in Part 2 will receive the same dose level of 5-azacytidine
Study Drug Administration
Each study cycle is 28 days
Participant will take ponatinib tablets by mouth 1 time every day while they are on study Participant should swallow the tablets whole Participant should not crush them
If participant is enrolled in Part 2 they will receive 5-azacytidine either by vein over about 1 hour or as an injection under the skin on Days 1-7 of each study cycle or on Days 1-5 8 and 9 of each study cycle if the clinic is closed on a weekend
If the doctor thinks it is needed the dose level dosing schedule or study cycle may be changed andor delayed The study doctor will discuss any changes with participant
Study Visits
On Day 1 of each cycle - 4 days participant will have a physical exam
On Day 1 -1 day of Cycles 1-3 and then every 3 cycles after that Cycles 6 9 12 and so on participant will have an EKG
On Day 1 of Cycle 2 and then every 3 cycles after that participant will have an ECHO or MUGA performed
One 1 time each week during Cycles 1-3 and then 1 time every 2-4 weeks after that blood about 1 tablespoon will be drawn for routine tests Participant may be able to have these blood draws performed at a local lab or clinic that is closer to their home The results of the testing will be sent to MD Anderson for review
On Day 28 - 7 days of Cycles 1 3 and then every 1-3 cycles after that participant will have a bone marrow aspirationbiopsy to check the status of the disease
One 1 time every 3 cycles if participant can become pregnant blood about 1-2 tablespoons will be drawn for a pregnancy test
At any time while participant is on study if the doctor thinks it is needed
Blood about 1-2 tablespoons will be drawn for routine tests
Participant may have a bone marrow aspirationbiopsy to check the status of the disease
Length of Study
Participant will receive ponatinib alone or ponatinib and 5-azacytidine for as long as the doctor thinks it is in their best interest Participant will no longer be able to take the study drugs if the disease gets worse if intolerable side effects occur or if they are unable to follow study directions
Patients participation on the study will be over after the follow-up visits
End-of-Study Visit
Within 14 days after participants last dose of study drugs
Participant will have a physical exam
Blood about 2-3 tablespoons will be drawn for routine tests
If the doctor thinks it is needed participant will have a bone marrow aspiratebiopsy to check the status of the disease
Follow-Up
About 30 days after the end-of-study visit a member of the study staff will call participant to ask if they have had any side effects andor started any new treatments This call should last about 5 minutes If the study staff thinks it is needed participant may also be asked to come into the clinic for a physical exam
Long-Term Follow-Up
If the disease appears to be responding to the study drugs a member of the study staff will call participant every 3-6 months for up to 5 years to ask how they are doing and about any side effects they may be having Each call should last about 5 minutes Participant may also be asked to come into the clinic for a physical exam if the study staff thinks it is needed
This is an investigational study 5-azacytidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome MDS Ponatinib is commercially available and FDA approved for the treatment of specific groups of chronic myeloid leukemia CML participants Their use in this study is considered investigational The study doctor can explain how the study drugs are designed to work
Up to 132 participants will take part in this study All will be enrolled at MD Anderson
If participant is found to be eligible to take part in this study they will be assigned to either Part 1 or Part 2 based on when they join this study
If participant is enrolled in Part 1 they will receive ponatinib alone for the first cycle If the doctor thinks it is needed the dose level may be increased If the disease does not respond to ponatinib alone participant will continue on to Part 2 of this study
Part 2 of this clinical research study will have 2 phases Phase 1 dose escalation and Phase 2 dose expansion
In Part 2 participant will be assigned to a study group based on when they join this study Up to 3 groups of 30 participants will be enrolled in Phase 1 of Part 2 and up to 60 participants will be enrolled in Phase 2
If participant is enrolled in Phase 1 the dose of ponatinib they receive will depend on when they join this study The first group of participants will receive the lowest dose level of ponatinib Each new group will receive a higher dose of ponatinib than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of ponatinib is found
If participant is enrolled in Phase 2 they will receive ponatinib at the highest dose that was tolerated in Phase 1
All participants in Part 2 will receive the same dose level of 5-azacytidine
Study Drug Administration
Each study cycle is 28 days
Participant will take ponatinib tablets by mouth 1 time every day while they are on study Participant should swallow the tablets whole Participant should not crush them
If participant is enrolled in Part 2 they will receive 5-azacytidine either by vein over about 1 hour or as an injection under the skin on Days 1-7 of each study cycle or on Days 1-5 8 and 9 of each study cycle if the clinic is closed on a weekend
If the doctor thinks it is needed the dose level dosing schedule or study cycle may be changed andor delayed The study doctor will discuss any changes with participant
Study Visits
On Day 1 of each cycle - 4 days participant will have a physical exam
On Day 1 -1 day of Cycles 1-3 and then every 3 cycles after that Cycles 6 9 12 and so on participant will have an EKG
On Day 1 of Cycle 2 and then every 3 cycles after that participant will have an ECHO or MUGA performed
One 1 time each week during Cycles 1-3 and then 1 time every 2-4 weeks after that blood about 1 tablespoon will be drawn for routine tests Participant may be able to have these blood draws performed at a local lab or clinic that is closer to their home The results of the testing will be sent to MD Anderson for review
On Day 28 - 7 days of Cycles 1 3 and then every 1-3 cycles after that participant will have a bone marrow aspirationbiopsy to check the status of the disease
One 1 time every 3 cycles if participant can become pregnant blood about 1-2 tablespoons will be drawn for a pregnancy test
At any time while participant is on study if the doctor thinks it is needed
Blood about 1-2 tablespoons will be drawn for routine tests
Participant may have a bone marrow aspirationbiopsy to check the status of the disease
Length of Study
Participant will receive ponatinib alone or ponatinib and 5-azacytidine for as long as the doctor thinks it is in their best interest Participant will no longer be able to take the study drugs if the disease gets worse if intolerable side effects occur or if they are unable to follow study directions
Patients participation on the study will be over after the follow-up visits
End-of-Study Visit
Within 14 days after participants last dose of study drugs
Participant will have a physical exam
Blood about 2-3 tablespoons will be drawn for routine tests
If the doctor thinks it is needed participant will have a bone marrow aspiratebiopsy to check the status of the disease
Follow-Up
About 30 days after the end-of-study visit a member of the study staff will call participant to ask if they have had any side effects andor started any new treatments This call should last about 5 minutes If the study staff thinks it is needed participant may also be asked to come into the clinic for a physical exam
Long-Term Follow-Up
If the disease appears to be responding to the study drugs a member of the study staff will call participant every 3-6 months for up to 5 years to ask how they are doing and about any side effects they may be having Each call should last about 5 minutes Participant may also be asked to come into the clinic for a physical exam if the study staff thinks it is needed
This is an investigational study 5-azacytidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome MDS Ponatinib is commercially available and FDA approved for the treatment of specific groups of chronic myeloid leukemia CML participants Their use in this study is considered investigational The study doctor can explain how the study drugs are designed to work
Up to 132 participants will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-01187 | OTHER | NCI CTRP | None |