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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.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00968981
First received: August 28, 2009
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
Drug Information available for: Vismodegib
U.S. FDA Resources

Further study details as provided by Genentech:

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968981

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

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov 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:
Hedgehog
BCC
basal cell carcinoma

ClinicalTrials.gov processed this record on May 19, 2013