Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung
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.
Study Start Date
Estimated Completion Date
- Drug: pazopanib
- Pulmonology: Lung/Thoracic Oncology
- Oncology: Bone/Cartilage,Lung/Thoracic Oncology,Pharmacology/Therapy
- Pharmacy: Chemotherapy/Oncology,Drug Trials
- Neoplasm Metastasis
ACORN Research, LLC -- ACORN AWACMOS1102
ACORN Research, LLC
- 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.
- 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.
16 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (6)
|Massachusetts General HospitalDana Farber Cancer Institute - Boston, Massachusetts||2.8 miles||Barbara Anderson RNfirstname.lastname@example.org|
|Pennsylvania Oncology Hematology Associates - Philadelphia, Pennsylvania||269.1 miles||None||None||None|
|Mayo Clinic - Rochester, Minnesota||1,083.1 miles||None||None||None|
|MD Anderson Cancer Center - Houston, Texas||1,609.9 miles||Phuc Le RN BSN||713-745-8423||PHle@mdanderson.org|
|City of Hope - Duarte, California||2,578.2 miles||Julie Kilpatrick RN MSNemail@example.com|
|Sarcoma Oncology Research Center - Santa Monica, California||2,608.5 miles||Victoria S ChuaAlcalafirstname.lastname@example.org|