NCT00832871

Brief Summary

The purpose of this study is to see if mifepristone prevents worsening of your cancer. Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is commonly used for the termination of pregnancies. It has not been approved by the Food and Drug Administration for use in the treatment of cancer. It is unlicensed in the United States for your condition. However, previous work has indicated that mifepristone may be useful due to how it works. It is being made available for use in the United States for compassionate use through the Feminist Majority Foundation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable cancer

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

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 2, 2016

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

7.1 years

First QC Date

January 29, 2009

Results QC Date

June 22, 2016

Last Update Submit

May 30, 2018

Conditions

Cancer

Keywords

MifepristoneRU-486Compassionate UseAntiprogesterone

Outcome Measures

Primary Outcomes (1)

  • Duration of Response

    The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    5 years

Secondary Outcomes (1)

  • Toxicity Associated With Adrenal Insufficiency

    Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)

Other Outcomes (1)

  • Overall Survival

    5 years

Study Arms (1)

Mifepristone

EXPERIMENTAL

200 mg RU-486 (Mifepristone) daily

Drug: Mifepristone

Interventions

MifepristoneDRUG

Mifepristone 200 mg will be administered orally

Also known as: RU-486; Mifeprex
Mifepristone

Eligibility Criteria

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

You may qualify if:

  • All patients 18 years of age or older.
  • Patients must sign an informed consent.
  • Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks.

You may not qualify if:

  • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtiy of New Mexico - Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

This is a compassionate use protocol. No statistical analysis was specified in the protocol; it states that only descriptive data will be collected. Data from only 4 patients should not be considered reliable.

Results Point of Contact

Title
Dr. Fa-chyi Lee
Organization
University of New Mexico Comprehensive Cancer Center
FLee@salud.unm.edu
505-925-0405

Study Officials

  • Fa-Chyi Lee, M.D.

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 29, 2018

Results First Posted

August 2, 2016

Record last verified: 2018-05

Locations

US(1)