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Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

NCT01596751 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-07-17

Study results available
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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.

Conditions

Interventions

DRUG

PLX3397

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

DRUG

Eribulin

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

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Plexxikon

    collaborator INDUSTRY

  • Hope Rugo, MD

    lead OTHER

Principal Investigators

  • Hope S. Rugo, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-12
Primary Completion
2017-07-05
Completion
2019-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01596751 on ClinicalTrials.gov