Ignite Creation Date:
2025-12-18 @ 9:10 AM
Ignite Modification Date:
2025-12-23 @ 5:41 PM
Study NCT ID:
NCT02070549
Status:
None
Last Update Posted:
2025-02-13 00:00:00
First Post:
2014-02-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase I Trial of Single Agent Trametinib (GSK1120212) in Advanced Cancer Patients With Hepatic Dysfunction
Status:
None
Status Verified Date:
2025-02
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:
PRIMARY OBJECTIVES:
I. To provide appropriate dosing recommendations for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe).
II. To establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction.
III. To characterize the pharmacokinetic (PK) profile of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To document the non-DLTs associated with the administration of trametinib in patients with varying degrees of hepatic dysfunction.
II. To document any antitumor activity associated with trametinib treatment of patients enrolled on this study.
III. To explore and characterize predictive biomarkers for individual cancer patients utilizing genomic sequencing technologies.
OUTLINE: This is a dose-escalation study.
Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Cycles 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 provide appropriate dosing recommendations for patients with varying degree of hepatic dysfunction receiving trametinib (mild, moderate and severe).
II. To establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction.
III. To characterize the pharmacokinetic (PK) profile of trametinib in advanced cancer patients with varying degrees of hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To document the non-DLTs associated with the administration of trametinib in patients with varying degrees of hepatic dysfunction.
II. To document any antitumor activity associated with trametinib treatment of patients enrolled on this study.
III. To explore and characterize predictive biomarkers for individual cancer patients utilizing genomic sequencing technologies.
OUTLINE: This is a dose-escalation study.
Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Cycles 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.
Detailed Description:
None
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?: