Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer
Phase 2
Withdrawn
- Conditions
- Breast Neoplasm
- Interventions
- Drug: Aminoflavone Prodrug
- Registration Number
- NCT01015521
- Lead Sponsor
- Tigris Pharmaceuticals
- Brief Summary
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- ER+ or TN Breast Cancer
- Progression on an aromatase inhibitor if ER+
- Prior treatment with taxane if TN
- 18 years or older
- Adequate organ function
- Measurable lesion
Exclusion Criteria
- symptomatic pulmonary disease
- brain metastases
- pregnant females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aminoflavone Prodrug Aminoflavone Prodrug Aminoflavone to treat ER positive breast cancer patients Aminoflavone Prodrug with pretreatment Aminoflavone Prodrug Aminoflavone Prodrug to treat Triple Negative Breast Cancer
- Primary Outcome Measures
Name Time Method Clinical Benefit Response 6 months
- Secondary Outcome Measures
Name Time Method Progression Free Survival 6 monhts