Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01596140
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2012-05-08
Brief Title:
Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Dose-Escalation Study of the BRAF Inhibitor Vemurafenib Zelboraf in Combination With an mTOR Inhibitor Everolimus Afinitor or Temsirolimus Torisel in Subjects With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2020-06
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 this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with either everolimus or temsirolimus The safety of these drug combinations will also be studied
Vemurafenib is designed to block BRAF inside the cancer cells which is a mutation that is involved in cancer cell growth
Temsirolimus and everolimus are designed to block the growth of cancer cells which may cause cancer cells to die
Vemurafenib is designed to block BRAF inside the cancer cells which is a mutation that is involved in cancer cell growth
Temsirolimus and everolimus are designed to block the growth of cancer cells which may cause cancer cells to die
Detailed Description:
Study Drug Administration
If you are found to be eligible to take part in this study your doctor will decide whether you will receive either everolimus or temsirolimus
You will be assigned to a dose level of vemurafenib based on when you join this study Up to 5 dose levels of vemurafenib will be tested Up to 6 participants will be enrolled at each dose level The first group of participants will receive the lowest dose level Each new group will receive a higher dose than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of vemurafenib is found
Study Drug Administration
You will take 3 vemurafenib tablets in the morning and 3 tablets in the eveningYou will take it every day during each 28-day study cycle You will take vemurafenib in combination with either 1 tablet of everolimus every day of each cycle or you will receive temsirolimus by vein over 30-60 minutes on Days 1 8 15 and 22 of each cycle
You will receive a dosing diary to record ONLY the date and times when you did NOT take a scheduled dose of the study drug You should bring this diary and any used or unused study drug bottles to your next study visit even empty bottles must be returned
Study Visits
At all study visits you will be asked about any drugs you may be taking and if you have had any side effects from them
On Days 1 and 15 of Cycle 1 and Day 1 of Cycle 6
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG Day 15 only
On Day 1 of Cycles 2 and 5
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
Your skin will be checked
You will have a CT scan or MRI scan to check the status of the disease Cycle 5 only
On Day 1 of Cycle 3
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a CT scan or MRI scan to check the status of the disease
On Day 1 of Cycle 4
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a head and neck exam to check the status of the disease
On Day 1 of Cycle 7
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have a CT scan or MRI scan to check the status of the disease
You will have a head and neck exam to check the status of the disease
On Day 1 of Cycles 8 and beyond
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
After Cycle 7 every 12 weeks
You will have an ECG
You will have a head and neck exam to check the status of the disease
Your skin will be checked
On Day 1 of every 2 cycles
You will have a CT scan or MRI scan to check the status of the disease
Length of Study
You may continue taking the study drugs for as long as the 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 once you have completed the follow-up
End of Study Drug Dosing Visit
Once you are no longer taking the study drug you will have a study visit At this visit
You will be asked about any drugs you may be taking and if you have had any side effects from them
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a CT scan or MRI scan to check the status of the disease
Your skin will be checked
Safety Follow-Up Visit
If you leave the study for any reason other than the disease getting worse you will have a follow-up visit about 28 days after your last dose At this visit
You will be asked about any drugs you may be taking and if you have had any side effects from them
You will have an ECG
Your skin will be checked
You will have a head and neck exam to check the status of the disease
Follow-Up
Every 3 months after the last dose of study drug for up to 12 months you will be contacted by phone and asked about any new drugs you may be taking This should take less than 5 minutes This follow up may be during a regularly scheduled clinic visit
Participant Responsibilities
Take the study drug as instructed by the study staff
Keep your study appointments If you cannot keep an appointment reschedule as soon as you know that you will miss the appointment
Tell your doctor or study staff about any side effects doctor visits or hospitalizations that you may have
Keep the study drug in a safe place for your use only and away from children It must be stored at room temperature but not warmer than 77 degrees F 25 degrees Celsius
Complete your diaries as instructed
While on this study you cannot take part in any other research project without approval from your doctor
This is an investigational study Vemurafenib is FDA-approved for metastatic melanoma Its use in other types of cancer is investigational Everolimus and temsirolimus are FDA approved kidney cancer The combination of these drugs is investigational
Up to 114 participants will be enrolled in this study All will take part at MD Anderson
If you are found to be eligible to take part in this study your doctor will decide whether you will receive either everolimus or temsirolimus
You will be assigned to a dose level of vemurafenib based on when you join this study Up to 5 dose levels of vemurafenib will be tested Up to 6 participants will be enrolled at each dose level The first group of participants will receive the lowest dose level Each new group will receive a higher dose than the group before it if no intolerable side effects were seen This will continue until the highest tolerable dose of vemurafenib is found
Study Drug Administration
You will take 3 vemurafenib tablets in the morning and 3 tablets in the eveningYou will take it every day during each 28-day study cycle You will take vemurafenib in combination with either 1 tablet of everolimus every day of each cycle or you will receive temsirolimus by vein over 30-60 minutes on Days 1 8 15 and 22 of each cycle
You will receive a dosing diary to record ONLY the date and times when you did NOT take a scheduled dose of the study drug You should bring this diary and any used or unused study drug bottles to your next study visit even empty bottles must be returned
Study Visits
At all study visits you will be asked about any drugs you may be taking and if you have had any side effects from them
On Days 1 and 15 of Cycle 1 and Day 1 of Cycle 6
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG Day 15 only
On Day 1 of Cycles 2 and 5
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
Your skin will be checked
You will have a CT scan or MRI scan to check the status of the disease Cycle 5 only
On Day 1 of Cycle 3
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a CT scan or MRI scan to check the status of the disease
On Day 1 of Cycle 4
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a head and neck exam to check the status of the disease
On Day 1 of Cycle 7
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have a CT scan or MRI scan to check the status of the disease
You will have a head and neck exam to check the status of the disease
On Day 1 of Cycles 8 and beyond
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
After Cycle 7 every 12 weeks
You will have an ECG
You will have a head and neck exam to check the status of the disease
Your skin will be checked
On Day 1 of every 2 cycles
You will have a CT scan or MRI scan to check the status of the disease
Length of Study
You may continue taking the study drugs for as long as the 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 once you have completed the follow-up
End of Study Drug Dosing Visit
Once you are no longer taking the study drug you will have a study visit At this visit
You will be asked about any drugs you may be taking and if you have had any side effects from them
You will have a physical exam including measurement of your vital signs
Your performance status will be recorded
Blood about 3 teaspoons will be drawn for routine tests
You will have an ECG
You will have a CT scan or MRI scan to check the status of the disease
Your skin will be checked
Safety Follow-Up Visit
If you leave the study for any reason other than the disease getting worse you will have a follow-up visit about 28 days after your last dose At this visit
You will be asked about any drugs you may be taking and if you have had any side effects from them
You will have an ECG
Your skin will be checked
You will have a head and neck exam to check the status of the disease
Follow-Up
Every 3 months after the last dose of study drug for up to 12 months you will be contacted by phone and asked about any new drugs you may be taking This should take less than 5 minutes This follow up may be during a regularly scheduled clinic visit
Participant Responsibilities
Take the study drug as instructed by the study staff
Keep your study appointments If you cannot keep an appointment reschedule as soon as you know that you will miss the appointment
Tell your doctor or study staff about any side effects doctor visits or hospitalizations that you may have
Keep the study drug in a safe place for your use only and away from children It must be stored at room temperature but not warmer than 77 degrees F 25 degrees Celsius
Complete your diaries as instructed
While on this study you cannot take part in any other research project without approval from your doctor
This is an investigational study Vemurafenib is FDA-approved for metastatic melanoma Its use in other types of cancer is investigational Everolimus and temsirolimus are FDA approved kidney cancer The combination of these drugs is investigational
Up to 114 participants will be enrolled in this study All will take part at MD Anderson
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 |
|---|---|---|---|
| NCI-2012-00789 | REGISTRY | NCI CTRP | None |