A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
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
- 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
- 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:
- 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 metastases or leptomeningeal
carcinomatosis
- Clinically significant gastrointestinal (GI) abnormalities that may increase the risk
for GI bleeding
- Clinically significant GI abnormalities that may affect absorption of investigational
product
- Presence of uncontrolled infection
- Corrected QT interval > 480 msecs using Bazett's formula
- History of certain cardiovascular conditions within the past 6 months
- Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg
or diastolic blood pressure of > or = 90 mmHg]
- History of cerebrovascular accident including transient ischemic attack, pulmonary
embolism, or untreated deep venous thrombosis within the past 6 months
- Prior major surgery or trauma within 28 days prior to the first dose of study drug
and/or presence of any non-healing wound, fracture, or ulcer
- Evidence of active bleeding or bleeding diathesis
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures
- Unable or unwilling to discontinue use of prohibited medications for at least 14 days
prior to the first dose of study drug and for the duration of study treatment
- Radiation therapy, surgery (except major surgery), tumor embolization, chemotherapy,
immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within
14 days prior to the first dose of study drug
- Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is
progressing in severity, except alopecia