NCT01233947

Brief Summary

AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

November 1, 2010

Last Update Submit

January 6, 2012

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Response

    Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.

    6 months

Secondary Outcomes (2)

  • Progression Free Survival

    6 months

  • Number of participants with adverse events

    6 months

Study Arms (2)

AFP464

EXPERIMENTAL

74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.

Drug: AFP464

AFP464 + Faslodex

EXPERIMENTAL

AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.

Drug: AFP464 + Faslodex

Interventions

AFP464DRUG

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle

Also known as: (aminoflavone)
AFP464
AFP464 + FaslodexDRUG

AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label

Also known as: (aminoflavone) + (Fulvestrant)
AFP464 + Faslodex

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29\>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.

You may not qualify if:

  • HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

aminoflavoneFulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Joanne L. Blume, M.D.

    Texas Oncology-Baylor Charles A. Sammons Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 3, 2010

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

US(1)