A Study of GDC-0449 As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission - Full Text View

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

MedlinePlus related topics:

Cancer Ovarian Cancer

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	100
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:

Age ≥ 18 years
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
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 12 weeks prior to screening.
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
Signed informed consent

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)
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

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