Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01166126
Status:
TERMINATED
Last Update Posted:
2014-05-15
First Post:
2010-07-12
Brief Title:
TemsirolimusAZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of mTOR Inhibitor Temsirolimus Combined With MEK Inhibitor AZD 6244 in Patients With BRAF Mutant Stage IV Melanoma
Status:
TERMINATED
Status Verified Date:
2012-12
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 purpose of this study is to find out how often two investigational drugs that are given together will shrink the patients tumor and how well they will prolong the time it takes their tumor to grow The investigators also wish to find out how they affect certain substances in the patients tumor and in their blood important for tumor growth The combination of these drugs is experimental and has not been proven to help treat melanoma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the clinical response rate Response Evaluation Criteria in Solid Tumors RECIST and one-year overall survival to the study drugs temsirolimus and AZD6244 selumetinib hydrogen sulfate in BRAF V600E mutant unresectable stage IV melanoma
SECONDARY OBJECTIVES
I Estimate 6-month progression-free survival in patients receiving temsirolimus and AZD6244 hydrogen sulfate
II Determine the pharmacodynamic effects of temsirolimus and AZD6244 on pERK s6K PTEN and mediators of apoptosis
III Determine the toxicity profile of temsirolimus with AZD6244 hydrogen sulfate
OUTLINE
Treatment Phase This period begins with the first intravenous through the vein infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth visit 2 Week 1 and will continue until Week 8 Visit 4
As many as 38 patients will receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks and the AZD6244 will be given as capsules by mouth twice a day for 8 weeks That is one cycle The TEMSIROLIMUS and AZD6244 will be given to participants as an outpatient unless admission to the hospital was needed for treatment of related side effects or underlying disease The subsequent cycles of TEMSIROLIMUS and AZD6244 will be given every 8 weeks The TEMSIROLIMUS will be injected in a vein over 30 minutes
The continuation phase begins with visits at weeks 12 in patients who receive at least two cycles of treatments
I To determine the clinical response rate Response Evaluation Criteria in Solid Tumors RECIST and one-year overall survival to the study drugs temsirolimus and AZD6244 selumetinib hydrogen sulfate in BRAF V600E mutant unresectable stage IV melanoma
SECONDARY OBJECTIVES
I Estimate 6-month progression-free survival in patients receiving temsirolimus and AZD6244 hydrogen sulfate
II Determine the pharmacodynamic effects of temsirolimus and AZD6244 on pERK s6K PTEN and mediators of apoptosis
III Determine the toxicity profile of temsirolimus with AZD6244 hydrogen sulfate
OUTLINE
Treatment Phase This period begins with the first intravenous through the vein infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth visit 2 Week 1 and will continue until Week 8 Visit 4
As many as 38 patients will receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks and the AZD6244 will be given as capsules by mouth twice a day for 8 weeks That is one cycle The TEMSIROLIMUS and AZD6244 will be given to participants as an outpatient unless admission to the hospital was needed for treatment of related side effects or underlying disease The subsequent cycles of TEMSIROLIMUS and AZD6244 will be given every 8 weeks The TEMSIROLIMUS will be injected in a vein over 30 minutes
The continuation phase begins with visits at weeks 12 in patients who receive at least two cycles of treatments
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 |
|---|---|---|---|
| P30CA076292 | NIH | CTEP | httpsreporternihgovquickSearchP30CA076292 |
| NCI-2012-02846 | REGISTRY | None | None |
| MCC-16066 | OTHER | None | None |
| 8436 | OTHER | None | None |