Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung

Status: Recruiting
Phase: Phase 2
Diagnosis: Sarcoma
NCT ID: NCT01759303 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-220

 

The purpose of this study is to determine the 4-month Progression-Free Survival (PFS), with demonstrated increase in tumor doubling time, of eligible subjects treated with pazopanib according to RECIST version 1.1 guidelines.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Children's Hospital Boston

Overall PI:
Edwin Choy, MD, Massachusetts General Hospital

Site-responsible Investigators:
David D'Adamo, M.D., Ph.D, Dana Farber Cancer Institute
Katherine Janeway, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org
Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Written informed consent or assent - Age > or = to 16 years - Histologically confirmed diagnosis of osteosarcoma with lung metastasis, who have progressed on the prior line of therapy, or relapsed - Ineligible for curative pulmonary metastasectomy - ECOG performance status of 0-2 - Measurable disease per RECIST version 1.1 guidelines. At least one measurable lesion must be in the lungs. - Eligible subjects are required to have > 1 line of multi-agent chemotherapy either neoadjuvantly or adjuvantly. Subjects may have had 0-2 lines of therapy for metastatic disease. - Measured cardiac ejection fraction > 50% or the institutional LLN by echocardiogram or MUGA scan. - Adequate organ system function. - Females must be either non-child bearing potential or have a negative pregnancy test within 3 to 5 days prior to the first dose of study drug. Exclusion Criteria: - Children in care. - Prior exposure to VEGFR tyrosine kinase inhibitor (small molecule or antibody) or VEGFR antibody. - 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. - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding. - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product. - Presence of uncontrolled infection. - Corrected QT interval (QTc) > 480 msecs using Bazett's formula. - History of certain cardiovascular conditions within the past 6 months. - Class II-IV congestive heart failure, as defined by the New York Heart Association - Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥ 140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - Prior major surgery or trauma within 28 days prior to the protocol-mandated 4-week drug holiday 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 (or one half teaspoon) 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/assent, 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 the study treatment. - Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the protocol-mandated 4-week drug holiday. - Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to the protocol-mandated 4-week drug holiday. - Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia. - An untreated tumor growth rate of < 6.1% during the Screening period may exclude some patients.
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