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NCT01015521 Clinical Trial

Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

Breast Neoplasm Clinical Trial

Official title:
A Two-Arm Open Label Phase II Study of AFP464 (Aminoflavone Prodrug) in Previously-treated ER-positive or Triple-negative Breast Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01015521
Other study ID # TG-AFP-002
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 16, 2009
Last updated November 1, 2010
Start date April 2010

Study information
Verified date November 2010
Source Tigris Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a phase II study to assess the efficacy of Aminoflavone prodrug in triple negative and ER+ breast cancer.

Recruitment information / eligibility
Status Withdrawn
Enrollment 50
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aminoflavone Prodrug
Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tigris Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Benefit Response 6 months No
Secondary Progression Free Survival 6 monhts No
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