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Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors

NCT01407562•Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

Detailed Description

This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
•At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
•Male or female ≥ 18 years of age
•Able to swallow and retain oral medications

Exclusion Criteria

•Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
•More than 3 prior lines of cytotoxic chemotherapy for metastatic disease

Locations (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Key Dates

Start Date

September 17, 2010

Primary Completion Date

March 29, 2016

Completion Date

March 29, 2016

Last Updated

September 28, 2022

Enrollment

ACTUAL participants

Conditions

Unspecified Adult Solid Tumor - Protocol SpecificBreast Cancer - Female

Interventions

Pazopanib

DRUG

Paclitaxel

DRUG

Carboplatin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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