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Phase I Study of the Combination of MLN9708 and Fulvestrant

NCT02384746 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-04-29

No results posted yet for this study

Summary

Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause.

There is information from research labs which suggests that drugs that work like MLN9708 help kill breast cancer cells that have been treated with fulvestrant. The purpose of the study is to determine the proper dose as well as the good and bad effects of MLN9708 when it is given in combination with fulvestrant. The Investigators also want to learn more about how the drug combination affects tumor cells.

The amount of MLN9708 participants receive will be determined by when they enter this study. Three different doses will be given to different participants. The Investigators expect to enroll a total of 12-18 people.

Conditions

Interventions

DRUG

Fulvestrant

500 mg intramuscular every 28 days

DRUG

MLN9708

Subjects will be treated in 3 dose cohorts of MLN9708, at 2.3, 3, and 4 mg orally on days 1, 4, 8, and 11 every 21 days.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Gary N Schwartz, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-02
Primary Completion
2018-04-12
Completion
2018-06-10

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02384746 on ClinicalTrials.gov