Phase 2
N=246
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Ovarian Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00791778 ↗Enrolled (actual)
246
Serious AEs
20.7%
Results posted
Nov 2012
Primary outcome: Primary: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment — 386; 478 Days — p=0.655
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment |
386; 478 | 0.655 |
| SECONDARY Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level |
337; 617 | 0.951 |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.84 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed International Federation of Gynecology and Obstetrics (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 (cancer-associated tumor marker) 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 Computed tomography (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.
Data sourced from ClinicalTrials.gov (NCT00791778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.