CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
PLX3397 +1 moredrug
Likely dose
PLX3397 200mgfrom 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/NCT01525602
NCT01525602Phase 1Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Feb 3, 2012·Updated Jul 16, 2020

In Brief

A Phase 1 clinical trial evaluating PLX3397 and Paclitaxel for Solid Tumors. Completed, enrolled 74 participants across 8 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesUnited States
CollaboratorsPlexxikon

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2017
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 14.4 years ago

Interventions

PLX3397drug

PLX3397 tablets, 200mg

Paclitaxeldrug

Paclitaxel IV