Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

Tigris Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Breast Neoplasm

Treatments: Drug: Aminoflavone Prodrug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015521

TG-AFP-002

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Aminoflavone Prodrug

Experimental group

Description:

Aminoflavone to treat ER positive breast cancer patients

Treatment:

Drug: Aminoflavone Prodrug

Aminoflavone Prodrug with pretreatment

Experimental group

Description:

Aminoflavone Prodrug to treat Triple Negative Breast Cancer

Treatment:

Drug: Aminoflavone Prodrug