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A Randomized, Placebo-Controlled Phase II Study of Vismodegib (GDC-0449, Systemic Hedgehog Antagonist) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

A Randomized, Placebo-Controlled Phase II Study of Vismodegib (GDC-0449, Systemic Hedgehog Antagonist) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer


Inclusion Criteria:



- Age ≥ 18 years

- Histologically confirmed metastatic colorectal cancer (CRC)

- Representative tumor specimens in paraffin blocks (preferred) or at least 15
unstained slides, with an associated pathology report, must be confirmed to be
available and requested at any time prior to entry of study

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematopoetic capacity

- Adequate hepatic function

- Adequate renal function

- Use of an effective method of barrier contraception (for women of childbearing
potential)

- Signed informed consent

Exclusion Criteria:

- Prior chemotherapy for metastatic CRC or adjuvant chemotherapy for CRC within the
prior 6 months

- Clinically suspected or confirmed CNS metastases or carcinomatous meningitis

- Major surgical procedure within 4 weeks prior to the first day of treatment in this
study (Day 1)

- Pelvic radiation within 2 weeks prior to Day 1

- Wound dehiscence requiring intervention, gastrointestinal perforation, or bowel
obstruction

- Pregnancy or lactation

- Uncontrolled medical illnesses including the following: Infection requiring
intravenous (IV) antibiotics, congestive heart failure not controlled with
medication, hypertension not controlled with medication

- Thromboembolic disease

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug or that might affect
interpretation of the results of the study or render the patient at high risk from
treatment complications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.

Outcome Time Frame:

From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks

Safety Issue:

No

Principal Investigator

Jennifer Low, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

SHH4429g

NCT ID:

NCT00636610

Start Date:

May 2008

Completion Date:

December 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • Hedgehog
  • CRC
  • Colorectal Cancer
  • Hedgehog Pathway Inhibitor
  • Colorectal Neoplasms

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