Clinical Trials Logo
  1. Home
  2. Advanced Malignant Neoplasm
  3. NCT01531361

Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations

Advanced Malignant Neoplasm Clinical Trial

Official title:
A Phase I Trial of Sorafenib (CRAF, BRAF, KIT, RET, VEGFR, PDGFR Inhibitor) or Crizotinib (MET, ALK, ROS1 Inhibitor) in Combination With Vemurafenib (BRAF Inhibitor) in Patients With Advanced Malignancies

Clinical Trial Summary

This phase I clinical trial studies vemurafenib with sorafenib tosylate or crizotinib in treating patients with advanced malignancies with BRAF mutations. Sorafenib tosylate and crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of advanced malignancies by blocking blood flow to tumors. Drugs used in chemotherapy, such as vemurafenib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vemurafenib together with sorafenib tosylate or crizotinib may kill more cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of sorafenib tosylate (sorafenib) or crizotinib in combination with vemurafenib in patients with advanced cancers who progressed on standard therapy. SECONDARY OBJECTIVES: I. Preliminary assessment of antitumor efficacy of sorafenib or crizotinib combination with vemurafenib in patients with advanced cancers. II. Preliminary assessment of the pharmacokinetic (PK) profile of sorafenib or crizotinib in combination with vemurafenib. III. Preliminary assessment of biomarkers. OUTLINE: This is a dose-escalation study of vemurafenib and sorafenib tosylate. Patients are assigned to 1 of 2 treatment arms by their physician. ARM I: Patients receive vemurafenib orally (PO) twice daily (BID) and sorafenib tosylate PO BID on days 1-28. ARM II: Patients receive vemurafenib as in Arm I and crizotinib PO once daily (QD) or BID on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01531361
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1
Start date February 6, 2012
Completion date January 13, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03671226 - Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center N/A
Recruiting NCT05048160 - A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm Phase 1/Phase 2
Active, not recruiting NCT03287492 - RCT of QPS vs General Information Sheet N/A
Recruiting NCT01549067 - The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey N/A
Recruiting NCT04119037 - Cordotomy in Reducing Pain in Patients With Advanced Cancer N/A
Recruiting NCT04067336 - First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT04585750 - The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Phase 1/Phase 2
Completed NCT02823652 - Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer N/A
Completed NCT00244972 - Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer Phase 1
Recruiting NCT06297642 - TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. Phase 1
Active, not recruiting NCT01582191 - Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT03856060 - Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits N/A
Completed NCT04186884 - Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Completed NCT02583269 - Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery Phase 1
Withdrawn NCT03868423 - Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers Phase 2
Terminated NCT02940223 - Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer Phase 2
Active, not recruiting NCT01552434 - Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease Phase 1
Active, not recruiting NCT03021486 - Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer Phase 2/Phase 3
Recruiting NCT03203525 - Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer Phase 1
Completed NCT01624766 - Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers Phase 1