Chondrosarcoma Clinical Trial
Official title:
A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
Verified date | March 2023 |
Source | George Clinical Pty Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
Status | Completed |
Enrollment | 47 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre | Edgbaston | Birmingham |
United States | City of Hope | Duarte | California |
United States | MD Anderson | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Edward Cancer Center | Naperville | Illinois |
United States | Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
George Clinical Pty Ltd | GlaxoSmithKline |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Control at Week 16 | Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks). | Assessed at week 16 of study treatment | |
Secondary | Progression Free Survival (PFS) | The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks). No upper limits of duration of assessment are identified or defined in the protocol. | Cycle 1 day 1 until the subject experiences disease progression | |
Secondary | Overall Survival (OS) | The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol. | Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent |
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