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Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer

NCT ID: NCT01015521

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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

Detailed Description

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Conditions

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Breast Neoplasm

Keywords

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breast cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aminoflavone Prodrug

Aminoflavone to treat ER positive breast cancer patients

Group Type EXPERIMENTAL

Aminoflavone Prodrug

Intervention Type DRUG

Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Aminoflavone Prodrug with pretreatment

Aminoflavone Prodrug to treat Triple Negative Breast Cancer

Group Type EXPERIMENTAL

Aminoflavone Prodrug

Intervention Type DRUG

Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Interventions

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Aminoflavone Prodrug

Aminoflavone Prodrug administered D1, D8 of 21-day cycle

Intervention Type DRUG

Other Intervention Names

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AFP464

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tigris Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Chief Medical Officer

References

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Saito R, Miki Y, Hata S, Ishida T, Suzuki T, Ohuchi N, Sasano H. Aryl hydrocarbon receptor induced intratumoral aromatase in breast cancer. Breast Cancer Res Treat. 2017 Feb;161(3):399-407. doi: 10.1007/s10549-016-4063-x. Epub 2016 Nov 30.

Reference Type DERIVED
PMID: 27900579 (View on PubMed)

Other Identifiers

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TG-AFP-002

Identifier Type: -

Identifier Source: org_study_id