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Safety Study of PLX4032 in Patients With Solid Tumors

NCT00405587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2017-08-22

Study results available
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Summary

The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Conditions

  • Malignant Melanoma
  • Colorectal Carcinoma

Interventions

DRUG

PLX4032

Oral capsules administered BID

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Plexxikon

    lead INDUSTRY

Principal Investigators

  • Henry Hsu, MD · Plexxikon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2015-07-31
Completion
2016-02-29

Countries

  • United States
  • Australia

Study Locations

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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 NCT00405587 on ClinicalTrials.gov