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Pazopanib and ARQ 197 for Advanced Solid Tumors

NCT01468922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-07-01

Study results available
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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.

Conditions

Interventions

DRUG

Pazopanib

Vascular endothelial growth factor (VEGFR) inhibitor

DRUG

ARQ 197

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Alice P Chen, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-23
Primary Completion
2014-09-30
Completion
2016-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01468922 on ClinicalTrials.gov