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A Study of GDC-0449 (Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
This study is ongoing, but not recruiting participants.
First Received: August 21, 2008   Last Updated: January 21, 2010   History of Changes
Sponsor: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00739661
  Purpose

The proposed study is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of GDC-0449 in patients with ovarian cancer in a second or third complete remission. Patients will be randomized in a 1:1 ratio to either GDC-0449 or placebo. Randomization will be stratified based on whether their cancer is in a second or third complete remission.


Condition Intervention Phase
Ovarian Cancer
Drug: GDC-0449
Drug: placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of GDC-0449 As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of hedgehog ligand expression in archival tumor tissue [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Number and attribution of all adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: September 2008
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: GDC-0449
Oral repeating dose
2: Placebo Comparator Drug: placebo
Oral repeating dose

  Eligibility

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

Inclusion Criteria:

  • Histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
  • Must be in second or third complete remission, have received chemotherapy (platinum-based and/or non-platinum-based) for recurrent disease, and have achieved a complete remission after their most recent chemotherapy regimen. Complete remission is defined as no symptoms suggestive of persistent cancer, CT scan of the chest/abdomen/pelvis without evidence of ovarian cancer within 4 weeks of randomization, and normal CA-125 (measured within 2 weeks of randomization) following completion of prior chemotherapy. The study investigator should confirm the status of disease remission by CT scan before patient enrollment. If patient has lymphadenopathy by CT scan and the investigator thinks that it is unlikely due to ovarian cancer, this patient is considered eligible. If indicated, a confirmatory biopsy should be performed.
  • Patients must have completed their most recent cytotoxic chemotherapy regimen (platinum-based or non-platinum based) no less than 3 weeks and no more than 14 weeks prior to randomization
  • Archival tissue must be available and requested
  • Negative pregnancy test on Day 1
  • For women of childbearing potential: Use of two effective methods of contraception, including one barrier method

Exclusion Criteria:

  • Pregnancy or lactation
  • Patients whose ovarian cancer is in first remission
  • Patients must not have experienced more than two prior recurrences of disease
  • Concurrent non-protocol-specified anti-tumor therapy, either approved or unapproved (e.g., chemotherapy, hormonal therapy, other targeted therapy, radiation therapy, surgery, herbal therapy). Hormonal replacement therapies for treatment of postmenopausal symptoms do not exclude patients from this study.
  • Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study
  • History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated BCC or squamous-cell carcinoma of the skin; ductal carcinoma in situ of the breast; or carcinoma in situ of the cervix
  • Uncontrolled medical illnesses such as infection requiring IV antibiotics
  • Life expectancy < 12 weeks
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739661

Sponsors and Collaborators
Genentech
Investigators
Study Director: Josina Reddy, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: SHH4489g
Study First Received: August 21, 2008
Last Updated: January 21, 2010
ClinicalTrials.gov Identifier: NCT00739661     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Systemic Hedgehog
Hedgehog Pathway Inhibitor

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 09, 2010