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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR VISMODEGIB

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Clinical Trials for Vismodegib

Trial ID Title Status Sponsor Phase Summary
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.
NCT00822458 GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment Completed National Cancer Institute (NCI) Phase 1 This phase I trial is studying the side effects and best dose of GDC-0449 in treating young patients with medulloblastoma that is recurrent or did not respond to previous treatment. GDC-0449 may be effective in treating young patients with medulloblastoma.
NCT00833417 A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma Completed Genentech, Inc. Phase 2 This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.
NCT00878163 GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery Active, not recruiting National Cancer Institute (NCI) Phase 1 This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.
NCT00887159 A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Active, not recruiting National Cancer Institute (NCI) Phase 2 This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cisplatin and etoposide are more effective when given together with vismodegib or cixutumumab in treating small cell lung cancer.
NCT00939484 Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma Completed National Cancer Institute (NCI) Phase 2 This phase II trial is studying how well vismodegib works in treating adult patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and may be an effective treatment for medulloblastoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Vismodegib

Condition Name

Condition Name for Vismodegib
Intervention Trials
Basal Cell Carcinoma 12
Stage IV Pancreatic Cancer 4
Locally Advanced Basal Cell Carcinoma 3
Chondrosarcoma 2
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Condition MeSH

Condition MeSH for Vismodegib
Intervention Trials
Carcinoma 23
Carcinoma, Basal Cell 21
Adenocarcinoma 7
Medulloblastoma 5
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Clinical Trial Locations for Vismodegib

Trials by Country

Trials by Country for Vismodegib
Location Trials
United States 343
Italy 28
Canada 16
France 16
Spain 14
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Trials by US State

Trials by US State for Vismodegib
Location Trials
California 24
New York 18
Michigan 18
Texas 17
Pennsylvania 17
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Clinical Trial Progress for Vismodegib

Clinical Trial Phase

Clinical Trial Phase for Vismodegib
Clinical Trial Phase Trials
Phase 4 3
Phase 2 40
Phase 1/Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Vismodegib
Clinical Trial Phase Trials
Recruiting 21
Completed 20
Active, not recruiting 12
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Clinical Trial Sponsors for Vismodegib

Sponsor Name

Sponsor Name for Vismodegib
Sponsor Trials
National Cancer Institute (NCI) 21
Genentech, Inc. 20
Hoffmann-La Roche 11
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Sponsor Type

Sponsor Type for Vismodegib
Sponsor Trials
Industry 52
Other 37
NIH 21
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Daiichi Sankyo
McKinsey
Chubb
Chinese Patent Office
Cerilliant
Merck
Teva
McKesson

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