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

Sponsored by:	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

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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: Study completion ] [ 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: Study completion ] [ Designated as safety issue: Yes ]
Overall survival (OS) [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
Ovarian cancer symptom response [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]
General health status [ Time Frame: Study completion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 62 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Head Clinical Pharmacology )
Study ID Numbers:	12007, EudraCT: 2008-004429-41
Study First Received:	November 14, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00791778
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Peritoneal Neoplasma

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Ovarian epithelial cancer
Sorafenib
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009