Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

Completed · Phase 1

Conditions studied: Advanced Cancer, Solid Tumor

In brief

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.

Key facts

Study ID

NCT01596140

Run by

M.D. Anderson Cancer Center

People needed

27

Starts

2012-12-18

Expected to finish

2020-06-01

Last updated by the study team

2020-06-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmation of BRAF mutation-positive malignancy is required for selection of patients for vemurafenib therapy
• Measurable or non-measurable disease by RECIST 1.1.
• Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy available that improves survival by at least three months.
• Patients must be at least 3 weeks past receiving cytotoxic therapy and at least 5 half-lives after their previous treatment or 3 weeks, whichever is shorter, after biologic therapy. Patients may receive palliative radiotherapy immediately or during treatment provided that not all target lesions are radiated.
• ECOG performance status </= 2 (Karnofsky >/= 60%; Lansky Score >/= 50).
• Patients must have normal organ and marrow function defined as: absolute neutrophil count >/=1,000/mL; platelets >/=50,000/mL; creatinine < 2.0; total bilirubin < 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: ALT(SGPT) </= 5 X ULN.
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection requiring hospitalization; psychiatric illness/social situations that would limit compliance with study requirements.
• Exclusion of patients with creatinine >2.0 and bilirubin > 2.0.
• Pregnant or lactating women.
• Patients with a history of bone marrow transplant within the previous two years.
• Patients with a known hypersensitivity to any of the components of the drug products.
• Patients with major surgery within 30 days prior to entering the study.
• Patients with a baseline QTc > 500 ms.
• Patients who are unable to swallow pills.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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