Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01417065
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2011-08-12
Brief Title:
Temsirolimus In Phase 0
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 0 Trial Evaluating the Effect of Temsirolimus on Known Pharmacodynamic Targets
Status:
COMPLETED
Status Verified Date:
2014-06
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 trial is to study the effects of the FDA-approved drug temsirolimus using a new type of clinical study design called a Phase 0 This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested
The purpose of the study is not to treat the cancer but to help improve general cancer treatment knowledge
The purpose of the study is not to treat the cancer but to help improve general cancer treatment knowledge
Detailed Description:
Study Drug
Temsirolimus is designed to block the growth of cancer cells which may cause the cancer cells to die
Study Drug Administration
If you are found to be eligible to take part in this study you will receive temsirolimus by vein over about 60 minutes on Day 1
You will be assigned to a dose level of temsirolimus based on when you join this study Up to 5 dose levels of temsirolimus will be tested Up to 3 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 until the drug is found to affect the enzyme that was tested for at screening
Study Visits
At each study visit you will be asked about any drugs you may be taking and about any side effects you may be having
On Day 1
-Blood about 2 teaspoons each time will be drawn before you receive the study drug and 5 times over the 24 hours after you receive the study drug for pharmacokinetic PK testing PK testing measures the amount of study drug in the body at different time points
Blood about 4 teaspoons each time will be drawn for pharmacodynamic PD testing PD testing measures how the level of study drug in your body may affect the disease This blood will be drawn at 1 or more of the following times but if the doctor thinks it is needed blood will be drawn at 2 or all 3 of the following times
At 4 hours - 2 hours after the dose
At 24 hours - 3 hours after the dose
At 72 hours - 24 hours after the dose
After the blood for PD testing has been tested and the tests show that the study drug may be causing changes to the tumor cells in at least 2 out of 3 participants future participants will have tumor tissue collected before and after dosing for testing Leftover tissue from an earlier biopsy can be used instead of a fresh biopsy before dosing if it is available
Length of Study
You will be on study for up to 4 days You will be taken off study early if you have intolerable side effects
Because it takes 4 days for temsirolimus to be completely processed by the body you will not be able to begin receiving drugs in any other study until 4 days after the dose
This is an investigational study Temsirolimus is FDA approved and commercially available for the treatment of advanced renal cancer Its use in other types of cancer is investigational
Up to 30 patients will take part in this study All will be enrolled at MD Anderson
Temsirolimus is designed to block the growth of cancer cells which may cause the cancer cells to die
Study Drug Administration
If you are found to be eligible to take part in this study you will receive temsirolimus by vein over about 60 minutes on Day 1
You will be assigned to a dose level of temsirolimus based on when you join this study Up to 5 dose levels of temsirolimus will be tested Up to 3 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 until the drug is found to affect the enzyme that was tested for at screening
Study Visits
At each study visit you will be asked about any drugs you may be taking and about any side effects you may be having
On Day 1
-Blood about 2 teaspoons each time will be drawn before you receive the study drug and 5 times over the 24 hours after you receive the study drug for pharmacokinetic PK testing PK testing measures the amount of study drug in the body at different time points
Blood about 4 teaspoons each time will be drawn for pharmacodynamic PD testing PD testing measures how the level of study drug in your body may affect the disease This blood will be drawn at 1 or more of the following times but if the doctor thinks it is needed blood will be drawn at 2 or all 3 of the following times
At 4 hours - 2 hours after the dose
At 24 hours - 3 hours after the dose
At 72 hours - 24 hours after the dose
After the blood for PD testing has been tested and the tests show that the study drug may be causing changes to the tumor cells in at least 2 out of 3 participants future participants will have tumor tissue collected before and after dosing for testing Leftover tissue from an earlier biopsy can be used instead of a fresh biopsy before dosing if it is available
Length of Study
You will be on study for up to 4 days You will be taken off study early if you have intolerable side effects
Because it takes 4 days for temsirolimus to be completely processed by the body you will not be able to begin receiving drugs in any other study until 4 days after the dose
This is an investigational study Temsirolimus is FDA approved and commercially available for the treatment of advanced renal cancer Its use in other types of cancer is investigational
Up to 30 patients 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 |
|---|---|---|---|
| 2K12CA088084-12 | NIH | NCI CTRP | httpsreporternihgovquickSearch2K12CA088084-12 |
| NCI-2011-02799 | REGISTRY | None | None |