A Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-Sponsored Phase I or II Cancer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00959647
First received: August 10, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This is a multicenter, open-label extension study. Patients receiving GDC-0449 in a Genentech-sponsored study who have completed the parent study or who contin ue to receive GDC-0449 at the time of the parent study closure are eligible for continued treatment on this protocol.


Condition Intervention Phase
Ovarian Cancer, Basal Cell Carcinoma, Metastatic Colorectal Cancer
Drug: bevacizumab
Drug: FOLFIRI
Drug: FOLFOX
Drug: GDC-0449
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Extension Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-Sponsored Phase I or Phase II Cancer Study

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and severity of all adverse events and serious adverse events [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Incidence of adverse events leading to GDC-0449 discontinuation [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (Metastatic Colorectal Cancer) Drug: bevacizumab
Intravenous repeating dose
Drug: FOLFIRI
Intravenous repeating dose
Drug: FOLFOX
Intravenous repeating dose
Drug: GDC-0449
Oral repeating dose
Experimental: B (Ovarian Cancer) Drug: GDC-0449
Oral repeating dose
Experimental: C (Basal Cell Carcinoma) Drug: GDC-0449
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

This study is onlyenrolling participants who took part in previous GDC-0449 studies conducted by Genentech.

Inclusion Criteria:

  • Completed GDC-0449 treatment within 2-4 weeks on the Genentech-sponsored parent study or continue to receive GDC-0449 at the time of the Genentech-sponsored parent study closure
  • Expectation by the investigator that the patient may continue to benefit from additional GDC-0449 treatment

Exclusion Criteria:

  • Intervening anti-tumor therapy not specified in the parent study (i.e., non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959647

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Oakland, California, United States, 94609
Palm Springs, California, United States, 92262
Stanford, California, United States, 94305
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0934
Detroit, Michigan, United States, 48201
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genentech
Investigators
Study Director: Josina Reddy, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00959647     History of Changes
Other Study ID Numbers: SHH4437g, GO01352
Study First Received: August 10, 2009
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Hedgehog pathway inhibitor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Colorectal Neoplasms
Ovarian Neoplasms
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014