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Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vector Oncology Identifier:
First received: April 6, 2011
Last updated: January 16, 2017
Last verified: January 2017
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.

Condition Intervention Phase
Metastatic Chondrosarcoma
Drug: pazopanib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Resource links provided by NLM:

Further study details as provided by Vector Oncology:

Primary Outcome Measures:
  • Disease control at week 16 [ Time Frame: Assessed at week 16 of study treatment ]
    Disease control at week 16 defined as complete response (CR) plus partial response (PR) plus stable disease (SD) 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).

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Continuously from the start of study treatment (Cycle 1 day 1) until 30 days after the end of treatment ]
    Toxicity will be assessed continuously during study participation through the reporting of adverse events (AEs) using the CTCAE (Common Terminology Criteria for Adverse Events)version 4.0

  • Progression free survival (PFS) [ Time Frame: Cycle 1 day 1 until the subject experiences disease progression ]
    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).

  • Overall survival (OS) [ Time Frame: Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent ]
    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.

Estimated Enrollment: 47
Study Start Date: April 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Drug: pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Other Name: Votrient


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01330966

United States, California
City of Hope
Duarte, California, United States, 91010
United States, Illinois
Edward Cancer Center
Naperville, Illinois, United States, 60540
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Edgbaston, Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Vector Oncology
Study Chair: Arthur Staddon, MD Pennsylvania Oncology Hematology Associates
Study Chair: Warren Chow, MD City of Hope Medical Center
  More Information

Responsible Party: Vector Oncology Identifier: NCT01330966     History of Changes
Other Study ID Numbers: AAPSMCS1002
Study First Received: April 6, 2011
Last Updated: January 16, 2017

Keywords provided by Vector Oncology:
surgically unresectable chondrosarcoma

Additional relevant MeSH terms:
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma processed this record on May 25, 2017