CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Pazopanib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01468922
NCT01468922Phase 1Completed

Phase Ib Study of the Combination of Pazopanib, an Oral VEGFR Inhibitor, and ARQ 197 (Tivantinib), an Oral MET Inhibitor, in Patients With Refractory Advanced Solid Tumors

National Cancer Institute (NCI)·interventional·Posted Nov 10, 2011·Updated Jul 1, 2022

In Brief

A Phase 1 clinical trial evaluating Pazopanib and ARQ 197 for Solid Tumor. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Background: \- Pazopanib is an anticancer drug that blocks the growth of new blood vessels in tumors. It has been approved to treat renal cell cancer and soft tissue sarcomas in patients who have received prior chemotherapy. ARQ 197 (Tivantinib) is an experimental drug that blocks a protein called mesenchymal-epithelial transition factor (c-MET), which cancer cells need to grow. Studies suggest that some drugs that block blood vessel growth can increase the production of c-MET in tumors, which helps cancer cells keep growing. Blocking both blood vessel growth and c-MET with pazopanib and ARQ 197 may help kill cancer cells faster. This study will use these drugs to treat solid tumors that have not responded to earlier treatments. Objectives: \- To test the safety and effectiveness of pazopanib and ARQ 197 for advanced solid tumors. Eligibility: \- Individuals at least 18 years of age who have advanced solid tumors that have not responded to earlier treatments. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and imaging studies. * The study drugs will be given in 4-week cycles of treatment. Participants will take pazopanib once a day and ARQ 197 twice a day by mouth. Some participants will start with pazopanib or ARQ 197 alone for the first week. Then they will take both drugs together for the rest of the study. * Participants will be monitored with frequent blood tests and imaging studies. Optional tumor samples may be collected during different treatment cycles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartJan 23, 2012
Primary CompletionSep 30, 2014
Study CompletionFeb 11, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.6 years ago

Interventions

Pazopanibdrug

Vascular endothelial growth factor (VEGFR) inhibitor

ARQ 197drug

Hepatocyte growth factor receptor (mesenchymal-epithelial transition factor \[c-MET\]) inhibitor