Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

NCT01454804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-04-13

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.

Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2 proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.

Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor.

Conditions

Interventions

DRUG

Pazopanib

Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.

DRUG

Lapatinib

Starting dose 500 mg by mouth every day for 28 days.

DRUG

Trastuzumab (Herceptin®)

4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1. Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein. Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase

DRUG

Pazopanib

Starting dose 200 mg by mouth every day for 28 days.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT01454804 on ClinicalTrials.gov