A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors

A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors

Solid Tumors

Completed

1

Start Date 11/01/2009

Age of Trial (yrs) 14.5

Gleevec-resistant

MEK inhibitor + PI3K inhibitor

Block related tumor signal paths

GIST not specified. GIST patients known to be enrolled.

MEK4752g, GO01330

Genentech

Please reference Study ID Number: MEK4752g 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Oral

Primary Outcome Measures:

* Incidence and nature of dose-limiting toxicities [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
* Incidence, nature and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
* PK parameters of GDC-0941 and GDC-0973 (total exposure, maximum plasma concentration, and minimum concentration) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Objective response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]