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

Description

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

April 2013

Estimated Completion Date

February 2018

Interventions

  • Drug: pazopanib

Specialties

  • Pulmonology: Lung/Thoracic Oncology
  • Oncology: Bone/Cartilage,Lung/Thoracic Oncology,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Neoplasm Metastasis
  • Osteosarcoma

Study ID

ACORN Research, LLC -- ACORN AWACMOS1102

Status

Unknown

Trial ID

NCT01759303

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

35

Sponsor

ACORN Research, LLC

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Massachusetts General HospitalDana Farber Cancer Institute - Boston, Massachusetts 2.8 miles Barbara Anderson RN 617-643-2427 banderson@partners.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 MSN 626-256-4673 jkilpatrick@coh.org
Sarcoma Oncology Research Center - Santa Monica, California 2,608.5 miles Victoria S ChuaAlcala 310-552-9999 vchua@sarcomaoncology.com

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