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A Phase II Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung

Phase 2
16 Years
Open (Enrolling)
Osteosarcoma, Metastatic Osteosarcoma

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Trial Information

A Phase II Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

4-month Progression Free Survival (PFS) per RECIST version 1.1 guidelines

Outcome Description:

The primary objective of the study is to evaluate the 4-month PFS (with demonstrated increase in tumor doubling time) of eligible subjects treated with pazopanib according to RECIST version 1.1 guidelines. Tumor growth rate will be calculated by measuring growth at the specified intervals for the single, longest dimension of the tumor(s) (RECIST) and by calculating the area of the tumor(s), which will be the product of the longest dimension of the tumor(s) multiplied by its longest, perpendicular dimension (WHO). Progressive disease (PD) for target lesions is defined as at least a 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions. Unequivocal progression of existing non-target lesions.

Outcome Time Frame:

4 months from the beginning of study treatment

Safety Issue:


Principal Investigator

Warren Chow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

February 2018

Related Keywords:

  • Osteosarcoma
  • Metastatic Osteosarcoma
  • Osteosarcoma



Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107