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Last Updated: July 31, 2021

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CLINICAL TRIALS PROFILE FOR GDC-0349


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Clinical Trials for GDC-0349

Trial ID Title Status Sponsor Phase Summary
NCT00467779 ↗ Study of Cobimetinib in Participants With Solid Tumors Completed Genentech, Inc. Phase 1 This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.
NCT00607724 ↗ GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating patients with locally advanced or metastatic solid tumors.
NCT00607724 ↗ GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors Completed Sidney Kimmel Comprehensive Cancer Center Phase 1 RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating patients with locally advanced or metastatic solid tumors.
NCT00607724 ↗ GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors Completed Genentech, Inc. Phase 1 RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating patients with locally advanced or metastatic solid tumors.
NCT00636610 ↗ A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer Completed Genentech, Inc. Phase 2 This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) chemotherapy with bevacizumab. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. Patients were randomized to receive vismodegib or placebo and were stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid Tumors (RECIST) measurable disease was present at baseline.
NCT00739661 ↗ A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission Completed Genentech, Inc. Phase 2 The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo. Randomization was stratified based on whether their cancer was in a second or third complete remission.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for GDC-0349

Condition Name

Condition Name for
Intervention Trials
Healthy Volunteer 21
Breast Cancer 16
Solid Cancers 11
Healthy Volunteers 8
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Condition MeSH

Condition MeSH for
Intervention Trials
Breast Neoplasms 27
Carcinoma 17
Lymphoma 15
Leukemia 13
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Clinical Trial Locations for GDC-0349

Trials by Country

Trials by Country for
Location Trials
United States 779
Spain 80
Italy 77
Australia 66
Canada 43
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Trials by US State

Trials by US State for
Location Trials
California 59
Massachusetts 50
Tennessee 46
New York 46
Texas 44
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Clinical Trial Progress for GDC-0349

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 8
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 69
Recruiting 45
Active, not recruiting 30
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Clinical Trial Sponsors for GDC-0349

Sponsor Name

Sponsor Name for
Sponsor Trials
Genentech, Inc. 109
National Cancer Institute (NCI) 34
Hoffmann-La Roche 15
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 148
Other 58
NIH 34
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