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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma, Ovarian Cancer, Metastatic Colorectal Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of all adverse events and serious adverse events

Outcome Time Frame:

30 days following the last administration of study treatment

Safety Issue:

No

Principal Investigator

Josina Reddy, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

SHH4437g

NCT ID:

NCT00959647

Start Date:

September 2009

Completion Date:

November 2013

Related Keywords:

  • Basal Cell Carcinoma, Ovarian Cancer, Metastatic Colorectal Cancer
  • Hedgehog pathway inhibitor
  • Carcinoma
  • Carcinoma, Basal Cell
  • Colorectal Neoplasms
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Phoenix, Arizona  85012
Fountain Valley, California  92708
Cleveland, Ohio  44195
Austin, Texas  78705
Flint, Michigan  48532
Baltimore, Maryland  21287
Las Vegas, Nevada  89109