NCT01015521WithdrawnPhase 2
A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Tigris Pharmaceuticals
- Enrollment
- 50
- Primary Endpoint
- Clinical Benefit Response
Study Overview
Brief Summary
This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Aminoflavone Prodrug
Experimental
Aminoflavone to treat ER positive breast cancer patients
Intervention: Aminoflavone Prodrug (Drug)
Aminoflavone Prodrug with pretreatment
Experimental
Aminoflavone Prodrug to treat Triple Negative Breast Cancer
Intervention: Aminoflavone Prodrug (Drug)
Outcomes
Primary Outcomes
Clinical Benefit Response
Time Frame: 6 months
Secondary Outcomes
- Progression Free Survival(6 monhts)
Investigators
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