TRIAL DETAIL

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

Drug:
Trial Name:
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
NCT#:
Conditions:
Solid Tumors
Status:
Completed
Phase:
1
Start Date 11/01/2009
Age of Trial (yrs) 12.1
Treatment Phase:
Gleevec-resistant
Drug Category:
MEK inhibitor + PI3K inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
GIST not specified. GIST patients known to be enrolled.
Other Protocol IDs:
MEK4752g, GO01330
Sponsor:
Genentech
Patient Contact:
Please reference Study ID Number: MEK4752g 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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 ]

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
3322 West End Avenue
Nashville
TN
37203
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
4100 John R
Detroit
MI
48201
USA
Oklahoma City
OK
73104
USA
55 Fruit Street
Boston
MA
02114
USA
Baltimore
MD
21231
USA