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NCT02384746 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of the Combination of MLN9708 and Fulvestrant

A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.

Terminated
Registry status
Phase 1
Development phase
9
Enrollment target

NCT02384746: Clinical Trial Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.

NCT02384746 is a Phase 1 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02384746, a Phase 1 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.

TERMINATED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

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.

Primary Outcome

If the current dose of MLN9708 does not induce any grade 3 non-hematologic toxicity, or any grade 4 hematologic toxicity in any of 3 subjects treated for one cycle, another 3 participants will be treated at the next dose level of MLN9708 (up to 4mg, which is the current phase 3 dose)

Interventions

  • DRUG Fulvestrant
  • DRUG MLN9708

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2015-06-02
Est. Completion 2018-06-10
Phase Phase 1
Dartmouth-Hitchcock Medical Center

427 total trials

Why NCT02384746 stopped before completion

NCT02384746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.

NCT02384746 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02384746 about?

NCT02384746 is a clinical study titled "Phase I Study of the Combination of MLN9708 and Fulvestrant". 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...

What is the current status of trial NCT02384746?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2015-06-02. Estimated completion is 2018-06-10.

What interventions are being tested in trial NCT02384746?

The interventions under investigation include: Fulvestrant (DRUG), MLN9708 (DRUG).

Who is sponsoring clinical trial NCT02384746?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02384746's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02384746, the US trial registry maintained by the National Library of Medicine. NCT02384746 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.