drugset / Trial / NCT00607724
GDC-0449 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Phase 1
Completed
68 enrolled
Genentech, Inc.
National Cancer Institute (NCI) · collabSidney Kimmel Comprehensive Cancer Center at Johns Hopkins · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2009-11
- Completion
- 2009-11
Publications
- Thacker CA, Weiss GJ, Tibes R, Blaydorn L, Downhour M, White E, Baldwin J, Hoff DD, Korn RL. 18-FDG PET/CT assessment of basal cell carcinoma with vismodegib. Cancer Med. 2012 Oct;1(2):230-6. doi: 10.1002/cam4.33. Epub 2012 Sep 17.
- Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009 Sep 17;361(12):1164-72. doi: 10.1056/NEJMoa0905360. Epub 2009 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vismodegib | Small molecule | 150 mg | Oral |
| Subject | Vismodegib | Small molecule | 270 mg | Oral |
| Subject | Vismodegib | Small molecule | 540 mg | Oral |