A Randomized Phase 2 Study of CBX 12 in Subjects With Platinum Resistant or Refractory Ovarian Cancer
Cybrexa Therapeutics
Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of CBX-12 in female subjects with platinum resistant or refractory ovarian cancer at 2 doses; 125 mg/m2 every 21 days or 100 mg/m2 every 21 days.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must have histologically- or cytologically-diagnosed epithelial high-grade serous cancer of the ovary, fallopian tube cancer or primary peritoneum cancer that is refractory to prior therapy and must have platinum-resistant disease defined as: * Subjects who have received only 1 platinum-based chemotherapy regimen for at least 4 cycles of platinum must have disease progression on treatment or occurring ≤ 26 weeks after their last dose of platinum. * Patients who have progressed following a second course of a platinum based regimen. * Subjects may have up t…
Interventions
- DrugCBX-12
CBX-12 is an alphalex construct which contains exatecan as the pharmacologically active moiety.
Locations (17)
- Honor HealthScottsdale, Arizona
- Arizona Oncology AssociatesTucson, Arizona
- Usc Norris Comprehensive Cancer CenterLos Angeles, California
- Yale University School of MedicineNew Haven, Connecticut
- D&H Cancer Research CenterMargate, Florida
- South Florida GynecologyTampa, Florida