Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Chondrosarcoma

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.

pazopanib

Arthur Staddon, MD

Warren Chow, MD

The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.

This research study is being conducted in adult subjects with a type of bone cancer called chondrosarcoma that has spread to other parts of the body and is not able to be removed with surgery. There is only one study drug that will be used in this study. It is a drug that interferes with cell communication and growth, taken orally. The study drug is called pazopanib.

Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).

The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks). No upper limits of duration of assessment are identified or defined in the protocol.

The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.

GlaxoSmithKline

George Clinical Pty Ltd

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.

pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.

Pazopanib

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.

pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.

Age, Continuous

Sex: Female, Male

Caucasian

Asian

Black or African American

Hispanic

Race/Ethnicity, Customized

United States

United Kingdom

Region of Enrollment

Lindsey Munn

Tumor responses were evaluable in 42 out of 47 patients; 5 patients discontinued prior to the first tumor assessment.

Spots Global Cancer Trial Database for Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Trial Identification

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Interventions

Study Description

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