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Completed Phase 1 Interventional Results available

Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT01525602

Public ClinicalTrials.gov record NCT01525602. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 4:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b Study to Assess the Safety of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Study identification

NCT ID
NCT01525602
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
74 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2012 (Type not available)
Primary completion
Dec 2017 (Actual)
Completion
Feb 2018 (Actual)
Last update posted
Jul 16, 2020

2012 – 2018

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
Univeristy of California, San Francisco San Francisco California 94143 —
University of Colorado, Anschutz Cancer Pavilion Aurora Colorado 80045 —
Sylvester Comprehensive Cancer Center/UMHC Miami Florida 33136 —
Mayo Clinic Rochester Minnesota 55905 —
University Hospitals of Cleveland Cleveland Ohio 44106 —
Ohio State University Columbus Ohio 43210 —
University of Utah, Huntsman Cancer Institute Salt Lake City Utah 84112 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01525602, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2020 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01525602 live on ClinicalTrials.gov.

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