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Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01015521
Enrollment
50
Registered
2009-11-18
Start date
2010-04-30
Completion date
Unknown
Last updated
2010-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Keywords

breast cancer

Brief summary

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

Interventions

DRUGAminoflavone Prodrug

Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Sponsors

Tigris Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Clinical Benefit Response6 months

Secondary

MeasureTime frame
Progression Free Survival6 monhts

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026