Ignite Creation Date:
2024-05-06 @ 7:26 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02530476
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2015-08-19
Brief Title:
Phase III Study of Selective Inhibitor of Nuclear Export SINE Selinexor KPT-330 Sorafenib in Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Selective Inhibitor of Nuclear Export SINE Selinexor KPT-330 Sorafenib in Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2020-03
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:
There are 2 parts to this study Part 1 dose escalation and Part 2 dose expansion
The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor KPT-330 and sorafenib Nexavar that can be given to patients with FLT3-ITD and -D835 mutated acute myeloid leukemia AML or FLT3-mutated high-risk myelodysplastic syndrome MDS
The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease
The safety of the drug combination will also be studied in both parts of this study
This is an investigational study Sorafenib is FDA approved and commercially available to treat hepatocellular cancer Selinexor is not FDA approved or commercially available It is currently being used for research purposes only The combination of selinexor and sorafenib to treat FLT3-mutated AML and high-risk MDS is investigational
The study doctor can explain how the study drugs are designed to work
Up to 52 participants will take part in this study All will be enrolled at MD Anderson
The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor KPT-330 and sorafenib Nexavar that can be given to patients with FLT3-ITD and -D835 mutated acute myeloid leukemia AML or FLT3-mutated high-risk myelodysplastic syndrome MDS
The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease
The safety of the drug combination will also be studied in both parts of this study
This is an investigational study Sorafenib is FDA approved and commercially available to treat hepatocellular cancer Selinexor is not FDA approved or commercially available It is currently being used for research purposes only The combination of selinexor and sorafenib to treat FLT3-mutated AML and high-risk MDS is investigational
The study doctor can explain how the study drugs are designed to work
Up to 52 participants will take part in this study All will be enrolled at MD Anderson
Detailed Description:
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 3 groups of up to 6 participants will be enrolled in Part 1 of the study and up to 40 participants will be enrolled in Part 2
If you are enrolled in Part 1 the dose of selinexor and sorafenib you receive will depend on when you joined this study The first group of participants will receive the starting dose combination level If no intolerable side effects were seen the next group will receive a higher dose of selinexor and sorafenib than Group 1 If intolerable side effects are seen the next group may receive a lower dose level of selinexor andor sorafenib This will continue until the highest tolerable combination dose is found
If you are enrolled in Part 2 you will receive selinexor and sorafenib at the highest tolerable combination dose or most effective combination dose found in Part 1
Study Drug Administration
Each study cycle is 28 days However the study cycles may be 3-12 weeks long depending on ifhow the disease responds to the treatment how your bone marrow reacts to treatment and what the doctor thinks is in your best interest
You will take selinexor tablets by mouth 2 times each week MondayWednesday or TuesdayThursday or WednesdayFriday for 3 weeks You must take your dose of selinexor within 30 minutes after eating with at least 4 ounces of fluids either water milk juice and so on You must swallow the tablets whole Do not crush them If the powder comes into contact with your skin you may have an increased chance of skin-related side effects
You will take sorafenib by mouth 2 times a day every day Depending on how the disease responds to the study drugs the number of days you receive the study drug may change Your doctor will discuss this with you You must take your dose of sorafenib at least 1 hour before or 1 hour after eating
You will be given a drug diary and asked to write down what time you take the study drugs every day You must bring in the study drug diary and any unused study drugs and bottles to each study visit
Study Visits
On Day 1 of Cycles 1-4 and then every 1-3 cycles after that
You will have a physical exam
You will have an EKG
The study doctor will tell you how often you will have these tests after Cycle 4
One time each week during Cycles 1-3 blood about 1 tablespoon will be drawn for routine tests After Cycle 3 you will have this blood draw 1 time every 2-4 weeks If the doctor thinks it is needed blood may need to be drawn more often or more than 1 tablespoon of blood may need to be drawn
After Cycle 1 you may be able to have these blood draws performed at a local lab or clinic that is closer to your home The results of the testing will be sent to MD Anderson for review The study doctor or study staff will discuss this option with you
On Day 28 of Cycles 1 and 3 - 7 days and then every 1-3 cycles after that you will have a bone marrow aspiration andor biopsy to check the status of the disease
Every 3 months - 14 days if you can become pregnant blood about 1-2 tablespoons or urine will be collected for a pregnancy test
If you stay on study for more than 6 months and you are not having side effects you may have some of the above tests more or less often The study doctor will discuss this with you
Length of Study
You may continue taking the study drugs for as long as the study doctor thinks it is in your best interest You will no longer be able to take the study drugs 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 after the follow-up visits
End-of-Study Visit
If you stop taking the study drugs before the end of Cycle 24
You will have a physical exam
Blood about 2-3 tablespoons will be drawn for routine tests
If the doctor thinks it is needed you will have a bone marrow aspirate to check the status of the disease
Follow-Up
About 30 days - 7 after your last dose of study drugs you will have a physical exam You may have this exam at MD Anderson or a local clinic near your home If you have this exam at a local clinic the results of the exam will be sent to MD Anderson for review
If you cannot come to MD Anderson or a local clinic you will be called by a member of the study staff and asked if you have had any side effects andor started any new treatments This call should last about 5 minutes
Long-Term Follow-Up
If the disease appears to get better and you are responding well to the study drug you will return to MD Anderson every 3-6 months for up to 5 years after your last dose of study drugs for the study staff to check how you are doing
If you cannot return to MD Anderson for these visits you may be called by a member of the study staff The call should last about 10 minutes
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 3 groups of up to 6 participants will be enrolled in Part 1 of the study and up to 40 participants will be enrolled in Part 2
If you are enrolled in Part 1 the dose of selinexor and sorafenib you receive will depend on when you joined this study The first group of participants will receive the starting dose combination level If no intolerable side effects were seen the next group will receive a higher dose of selinexor and sorafenib than Group 1 If intolerable side effects are seen the next group may receive a lower dose level of selinexor andor sorafenib This will continue until the highest tolerable combination dose is found
If you are enrolled in Part 2 you will receive selinexor and sorafenib at the highest tolerable combination dose or most effective combination dose found in Part 1
Study Drug Administration
Each study cycle is 28 days However the study cycles may be 3-12 weeks long depending on ifhow the disease responds to the treatment how your bone marrow reacts to treatment and what the doctor thinks is in your best interest
You will take selinexor tablets by mouth 2 times each week MondayWednesday or TuesdayThursday or WednesdayFriday for 3 weeks You must take your dose of selinexor within 30 minutes after eating with at least 4 ounces of fluids either water milk juice and so on You must swallow the tablets whole Do not crush them If the powder comes into contact with your skin you may have an increased chance of skin-related side effects
You will take sorafenib by mouth 2 times a day every day Depending on how the disease responds to the study drugs the number of days you receive the study drug may change Your doctor will discuss this with you You must take your dose of sorafenib at least 1 hour before or 1 hour after eating
You will be given a drug diary and asked to write down what time you take the study drugs every day You must bring in the study drug diary and any unused study drugs and bottles to each study visit
Study Visits
On Day 1 of Cycles 1-4 and then every 1-3 cycles after that
You will have a physical exam
You will have an EKG
The study doctor will tell you how often you will have these tests after Cycle 4
One time each week during Cycles 1-3 blood about 1 tablespoon will be drawn for routine tests After Cycle 3 you will have this blood draw 1 time every 2-4 weeks If the doctor thinks it is needed blood may need to be drawn more often or more than 1 tablespoon of blood may need to be drawn
After Cycle 1 you may be able to have these blood draws performed at a local lab or clinic that is closer to your home The results of the testing will be sent to MD Anderson for review The study doctor or study staff will discuss this option with you
On Day 28 of Cycles 1 and 3 - 7 days and then every 1-3 cycles after that you will have a bone marrow aspiration andor biopsy to check the status of the disease
Every 3 months - 14 days if you can become pregnant blood about 1-2 tablespoons or urine will be collected for a pregnancy test
If you stay on study for more than 6 months and you are not having side effects you may have some of the above tests more or less often The study doctor will discuss this with you
Length of Study
You may continue taking the study drugs for as long as the study doctor thinks it is in your best interest You will no longer be able to take the study drugs 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 after the follow-up visits
End-of-Study Visit
If you stop taking the study drugs before the end of Cycle 24
You will have a physical exam
Blood about 2-3 tablespoons will be drawn for routine tests
If the doctor thinks it is needed you will have a bone marrow aspirate to check the status of the disease
Follow-Up
About 30 days - 7 after your last dose of study drugs you will have a physical exam You may have this exam at MD Anderson or a local clinic near your home If you have this exam at a local clinic the results of the exam will be sent to MD Anderson for review
If you cannot come to MD Anderson or a local clinic you will be called by a member of the study staff and asked if you have had any side effects andor started any new treatments This call should last about 5 minutes
Long-Term Follow-Up
If the disease appears to get better and you are responding well to the study drug you will return to MD Anderson every 3-6 months for up to 5 years after your last dose of study drugs for the study staff to check how you are doing
If you cannot return to MD Anderson for these visits you may be called by a member of the study staff The call should last about 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P50CA100632 | NIH | NCI CTRP | httpsreporternihgovquickSearchP50CA100632 |
| NCI-2015-01523 | OTHER | None | None |