Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

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


Eligibility: 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.

Relevance to patient case: not relevant