CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
PLX3397 +1 moredrug
Likely dose
PLX3397 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01596751
NCT01596751Phase 2Completed
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Enhancing Efficacy of Chemotherapy in Triple Negative/Basal-Like Breast Cancer by Targeting Macrophages: A Multicenter Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

Hope Rugo, MD·interventional·Posted May 11, 2012·Updated Jul 17, 2020

In Brief

A Phase 2 clinical trial evaluating PLX3397 and Eribulin for Metastatic Breast Cancer. Completed, enrolled 67 participants across 3 sites.

Detailed Summary

The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397 when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2 portion of the study is to find out what effects, good and/or bad, these drugs have on patients and their metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsSusan G. Komen Breast Cancer Foundation, Plexxikon

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2012
Enrollment StartJul 12, 2012
Primary CompletionJul 5, 2017
Study CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 14.1 years ago

Interventions

PLX3397drug

Dosage Form: 100 mg or 200 mg capsules, Dosage: 400 - 1000 mg, oral administration

Eribulindrug

Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days