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Study of Vemurafenib, Carboplatin, and Paclitaxel

NCT01636622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-06-18

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with carboplatin and paclitaxel patients with advanced cancer. The safety of the study drug combination will also be studied.

Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or kill these cells.

Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA (the genetic material of cells).

Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells.

Conditions

Interventions

DRUG

Vemurafenib

Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle.

DRUG

Carboplatin

Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.

DRUG

Paclitaxel

Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Filip Janku, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-09
Primary Completion
2020-04-21
Completion
2020-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01636622 on ClinicalTrials.gov