A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Genentech

ClinicalTrials.gov Identifier:

NCT00739661

First received: August 21, 2008

Last updated: April 2, 2012

Last verified: April 2012

History of Changes

Results First Received: February 10, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Ovarian Cancer
Interventions:	Drug: Vismodegib 150 mg Drug: Placebo to vismodegib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Vismodegib 150 mg	Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Placebo to Vismodegib	Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.

Participant Flow: Overall Study

	Vismodegib 150 mg	Placebo to Vismodegib
STARTED	52	52
COMPLETED	6	10
NOT COMPLETED	46	42
Adverse Event	2	0
Physician decision to withdraw patient	1	0
Patient decision to withdraw	9	4
Disease progression, radiographic	33	37
Reason for discontinuation not available	1	1

Baseline Characteristics

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Reporting Groups

	Description
Vismodegib 150 mg	Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Placebo to Vismodegib	Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Total	Total of all reporting groups

Baseline Measures

	Vismodegib 150 mg	Placebo to Vismodegib	Total
Number of Participants [units: participants]	52	52	104
Age [units: years] Mean ± Standard Deviation	57.3 ± 10.2	58.6 ± 8.9	57.9 ± 9.6
Gender [units: participants]
Female	52	52	104
Male	0	0	0

Outcome Measures

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1. Primary:

Progression-free Survival (PFS) [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]

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Measure Type	Primary
Measure Title	Progression-free Survival (PFS)
Measure Description	PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.
Time Frame	From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat patient population: All randomized patients.

Reporting Groups

	Description
Vismodegib 150 mg	Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Placebo to Vismodegib	Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.

Measured Values

	Vismodegib 150 mg	Placebo to Vismodegib
Number of Participants Analyzed [units: participants]	52	52
Progression-free Survival (PFS) [units: Months] Median ( 95% Confidence Interval )	7.5 ( 5.59 to 11.24 )	5.8 ( 4.14 to 7.49 )

No statistical analysis provided for Progression-free Survival (PFS)

2. Secondary:

Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]

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3. Secondary:

Overall Survival [ Time Frame: From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Genentech, Inc
phone: 800-821-8590

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00739661 History of Changes
Other Study ID Numbers:	SHH4489g
Study First Received:	August 21, 2008
Results First Received:	February 10, 2012
Last Updated:	April 2, 2012
Health Authority:	United States: Food and Drug Administration

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