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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

GDC-0449

Intervention Type DRUG

Daily oral repeating dose

B

Group Type EXPERIMENTAL

GDC-0449

Intervention Type DRUG

Three times weekly oral repeating dose

C

Group Type EXPERIMENTAL

GDC-0449

Intervention Type DRUG

Once weekly oral repeating dose

Interventions

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GDC-0449

Daily oral repeating dose

Intervention Type DRUG

GDC-0449

Three times weekly oral repeating dose

Intervention Type DRUG

GDC-0449

Once weekly oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No