Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-17 @ 6:55 PM
Study NCT ID:
NCT01907802
Status:
TERMINATED
Last Update Posted:
2018-08-14
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction
Status:
TERMINATED
Status Verified Date:
2018-08
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 in treating patients with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)\^V600X mutations and renal or hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To assess for tumor response and various times to clinical event. II. To provide dosing recommendations for dabrafenib in patients with varying degrees of hepatic and renal dysfunction for possible inclusion in the label.
TERTIARY OBJECTIVES:
I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active metabolites.
OUTLINE: This is a dose-escalation study.
Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily \[QD\] on day 1 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 at 30 days.
I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)\^V600X mutations and renal or hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To assess for tumor response and various times to clinical event. II. To provide dosing recommendations for dabrafenib in patients with varying degrees of hepatic and renal dysfunction for possible inclusion in the label.
TERTIARY OBJECTIVES:
I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active metabolites.
OUTLINE: This is a dose-escalation study.
Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily \[QD\] on day 1 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 at 30 days.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01338 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC1211 | None | None | View | |
| 9343 | OTHER | Mayo Clinic Cancer Center LAO | View | |
| 9343 | OTHER | CTEP | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA132123 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062490 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA069912 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186644 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186686 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186690 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186691 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186709 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186716 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186717 | NIH | None | https://reporter.nih.gov/quic… | View |