Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma (NCT01330966) | Clinical Trial Compass
CompletedPhase 2
Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
United States47 participantsStarted 2011-04
Plain-language summary
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent.
* Age \> or = to 18 years.
* Histologically confirmed diagnosis of conventional chondrosarcoma of any grade.
* Surgically unresectable or metastatic disease.
* Any number of prior treatment regimens, including treatment naive subjects. Prior treatment with tyrosine kinase inhibitors is permitted.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1.
* Adequate organ system function determined within 14 days prior to first dose of study treatment.
* Left ventricular ejection fraction \> 50% or the institutional LLN within 28 days prior to the first dose of study treatment.
* Females must either be of non-child bearing potential or have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.
Exclusion Criteria:
* Prior treatment with pazopanib.
* Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes.
* Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).
* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first d…