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A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

This study has been completed.
Information provided by:
Genentech, Inc. Identifier:
First received: August 28, 2009
Last updated: August 11, 2011
Last verified: August 2011

This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.

Condition Intervention Phase
Solid Cancers
Drug: GDC-0449
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Scheduling Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence, nature, and severity of adverse events, including clinically significant changes in vital signs or abnormalities in safety-related laboratory parameters [ Time Frame: Within 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, duration of response, and objective response for activity-evaluable patients [ Time Frame: Within 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: September 2009
Arms Assigned Interventions
Experimental: A Drug: GDC-0449
Daily oral repeating dose
Experimental: B Drug: GDC-0449
Three times weekly oral repeating dose
Experimental: C Drug: GDC-0449
Once weekly oral repeating dose


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

Inclusion Criteria

  • Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
  • For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
  • Adequate hematopoietic capacity
  • Adequate hepatic function
  • Adequate renal function
  • At least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

Exclusion Criteria

  • Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
  • Active infection requiring intravenous (IV) antibiotics
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
  • Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
  • Pregnant or lactating
  • Treatment with excluded medications, including strong CYP450 inhibitors and inducers
  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 identifier: NCT00968981

Sponsors and Collaborators
Genentech, Inc.
Study Director: Jennifer Low, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00968981     History of Changes
Other Study ID Numbers: SHH4610g
Study First Received: August 28, 2009
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
basal cell carcinoma processed this record on November 20, 2014