Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
Condition: Chondrosarcoma; Metastatic Chondrosarcoma
MeSH terms: Chondrosarcoma
Intervention: pazopanib
Intervention description: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: surgically unresectable chondrosarcoma

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

Eligibility criteria:

        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 dose of study drug.

          -  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 that
             increase the risk of pulmonary hemorrhage.

          -  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
             or five half-lives of a drug (whichever is longer) 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 or five half-lives of a drug (whichever is longer) 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.

          -  Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
             chemically related to pazopanib or excipients that contraindicates participation.