Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00791778

Purpose

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

To compare the treatment groups in terms of progression free survival (PFS) which in this setting is based on time to CT-documented relapse [ Time Frame: Up to 32 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to first pathologic CA125 serum levels (needs to be confirmed with a second measurement within 2 weeks) [ Time Frame: Up to 32 month ] [ Designated as safety issue: Yes ]
Overall survival (OS) [ Time Frame: Up to 32 month ] [ Designated as safety issue: Yes ]
Ovarian cancer symptom response [ Time Frame: Up to 32 month ] [ Designated as safety issue: Yes ]
General health status [ Time Frame: Up to 32 month ] [ Designated as safety issue: Yes ]

Enrollment:	247
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2012
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Sorafenib (Nexavar, BAY43-9006) Patients in Sorafenib arm will receive 2 Sorafenib tablets (200mg each) twice a day and in continuous administration.
Placebo Comparator: Arm 2	Drug: Placebo Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed FIGO stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation.Patients must have achieved a clinical complete response(disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
Normal serum CA125 level within 7 days of first dose of sorafenib.
Eastern Cooperative Oncology Group (ECOG)performance status of 0 or 1.
All scans used to document complete response must be done within 30 days prior to randomization.
Patients must be able to swallow and retain oral medication.

Exclusion Criteria:

Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard CT or magnetic resonance imaging (MRI).
Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791778

Show 60 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00791778 History of Changes
Other Study ID Numbers:	12007, 2008-004429-41
Study First Received:	November 14, 2008
Last Updated:	January 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Peritoneal Neoplasma

Additional relevant MeSH terms:

Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms

Endocrine System Diseases
Gonadal Disorders
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012