Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
This trial is active, not recruiting.
|Conditions||chondrosarcoma, metastatic chondrosarcoma|
|Targets||VEGF, PDGF, KIT|
|Start date||April 2011|
|End date||April 2017|
|Trial size||47 participants|
|Trial identifier||NCT01330966, AAPSMCS1002|
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Duarte, CA||City of Hope Comprehensive Cancer Center||no longer recruiting|
|Naperville, IL||Edward Cancer Center||no longer recruiting|
|Iowa City, IA||University of Iowa / Holden Comprehensive Cancer Center||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|Philadelphia, PA||Pennsylvania Oncology Hematology Associates||no longer recruiting|
|Houston, TX||M D Anderson Cancer Center||no longer recruiting|
|Edgbaston, United Kingdom||University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Disease control at week 16
time frame: Assessed at week 16 of study treatment
time frame: Continuously from the start of study treatment (Cycle 1 day 1) until 30 days after the end of treatment
Progression free survival (PFS)
time frame: Cycle 1 day 1 until the subject experiences disease progression
Overall survival (OS)
time frame: Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent
All participants at least 18 years old.
- 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.
- 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.
|Official title||A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma|
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