MedTrace Logo

Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients

NCT01430572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-06-06

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.

Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels.

Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.

Conditions

Interventions

DRUG

Pazopanib

Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered.

DRUG

Everolimus

Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered. Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase.

Sponsors & Collaborators

Principal Investigators

  • David S Hong, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-07
Primary Completion
2020-05-12
Completion
2020-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01430572 on ClinicalTrials.gov