Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01713972
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2012-10-22
Brief Title:
Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors
Sponsor:
Manisha Shah
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Trial of Dabrafenib BRAFi and Pazopanib in Patients With BRAF-mutated Advanced Malignant Tumors
Status:
COMPLETED
Status Verified Date:
2019-02
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:
This phase I trial studies the side effects and best dose of dabrafenib and pazopanib hydrochloride when given together in treating patients with advanced malignant tumors Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and tolerability of GSK2118436 dabrafenib given with pazopanib pazopanib hydrochloride as well as determining the maximum tolerated dosing regimen in patients with BRAF mutated advanced malignant tumors
SECONDARY OBJECTIVES
I Evaluate pharmacokinetics of the two study drugs and identify potential drug-drug interactions
II Determine pharmacogenomics with microarray testing III Perform genotyping of tumors and if objective tumor response rates are identified
IV Assess objective tumor response rates
OUTLINE This is a dose-escalation study
Patients receive dabrafenib orally PO twice daily BID on days 1-28 once daily on day 1 and BID on days 3-28 of course 1 and pazopanib hydrochloride PO once daily QD on days 1-28 days 2-28 of course 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 weeks
I To assess the safety and tolerability of GSK2118436 dabrafenib given with pazopanib pazopanib hydrochloride as well as determining the maximum tolerated dosing regimen in patients with BRAF mutated advanced malignant tumors
SECONDARY OBJECTIVES
I Evaluate pharmacokinetics of the two study drugs and identify potential drug-drug interactions
II Determine pharmacogenomics with microarray testing III Perform genotyping of tumors and if objective tumor response rates are identified
IV Assess objective tumor response rates
OUTLINE This is a dose-escalation study
Patients receive dabrafenib orally PO twice daily BID on days 1-28 once daily on day 1 and BID on days 3-28 of course 1 and pazopanib hydrochloride PO once daily QD on days 1-28 days 2-28 of course 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 weeks
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-2012-01935 | REGISTRY | None | None |
| NCCNGSK20014 | OTHER | NCCN | None |