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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01493310
Other study ID # 11-0546
Secondary ID NCI-2011-03525
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2011
Est. completion date May 2018

Study information

Verified date September 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer.

Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with mifepristone until their disease worsens or they experience an unacceptable side effect.

This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The study will first test the lowest dose in a small group of patients and if they do not have bad side effects, higher doses will be tested.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have metastatic (stage IV) or unresectable (cannot be removed by surgery) stage III breast cancer

- Patients must have evaluable disease

- Patients may have received adjuvant chemotherapy and up to four prior chemotherapy regimens for metastatic or locally recurrent disease and cannot have received prior nab-paclitaxel or mifepristone therapy for metastatic disease

- Patients who are estrogen receptor (ER)- and/or progesterone receptor (PR)-positive must have developed metastatic disease while on adjuvant hormonal therapy or have progression of disease after at least one hormonal therapy for advanced disease) and may have received unlimited prior hormonal therapies

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky > 60%)

- Absolute neutrophil count >= 1,500/mL

- Platelets >= 100,000/mL

- Total bilirubin =< institutional upper limit of normal (ULN)

- AST (serum glutamic oxaloacetic transaminase [SGOT])/ALT (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN

- Creatinine =< institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Morning cortisol >= institutional normal

- Negative serum or urine pregnancy test is required for women of child-bearing potential (able to get pregnant)

- Women of child-bearing potential and men who are sexually active must agree to use two forms of birth control prior to study entry and for the duration of study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational drugs or treatments

- Patients with known brain metastases are eligible as long as they have completed radiation to the brain and have been off of corticosteroid therapy for at least 4 weeks

- History of allergic reactions to compounds similar to mifepristone or paclitaxel/nab-paclitaxel; patients with a history of mild infusion reactions with paclitaxel who were able to continue to receive paclitaxel with corticosteroid premedications will be eligible to participate, as these cases were likely related to Cremophor and not paclitaxel

- Mifepristone may affect the way the body processes some types of drugs so they cannot be taken while on-study. These include but are not limited to non-steroidal anti-inflammatory drugs (NSAIDs) or warfarin, cyclosporine, certain benzodiazepines. The study doctor will review patient's current medications to determined if any are prohibited from the study.

- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if patient wishes to participate in the study

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

- No history of long-term or ongoing short term use of corticosteroids is allowed

Study Design


Intervention

Drug:
mifepristone
Given orally (by mouth) Up to 4 doses of mifepristone will be studied (300 mg, 600 mg, 900 mg, 1200 mg)
placebo
Given orally
nab-paclitaxel
Given by intravenous infusion (IV) Dose of 80 mg/m2

Locations

Country Name City State
United States University of Chicago Chicago Illinois
United States NorthShore University Health System Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel This study will seek the safest dose of mifepristone given in combination with nab-paclitaxel. Safety of each dose will be determined by the number and seriousness of side effects experienced by patients receiving each dose. 28days (Cycle 1)
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