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Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

NCT01596140 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-06-04

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 either everolimus or temsirolimus. The safety of these drug combinations will also be studied.

Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is involved in cancer cell growth.

Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause cancer cells to die.

Conditions

Interventions

DRUG

Vemurafenib

Starting dose 720 mg by mouth twice a day (3 tablets in the morning and 3 tablets in the evening) for 28-day study cycle.

DRUG

Everolimus

Starting dose 5.0 mg by mouth daily for 28-day study cycle.

DRUG

Temsirolimus

Starting dose 15 mg daily over 30-60 minutes on Days 1, 8, 15, and 22 of each 28-day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vivek Subbiah, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-18
Primary Completion
2020-06-01
Completion
2020-06-01
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 NCT01596140 on ClinicalTrials.gov