Clinical Trial: Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

Brief Summary: The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.

Detailed Summary:
Sponsor: Vector Oncology

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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 the subject dies, is lost to follow-up, or withdraws consent ]
    The time origin for OS will be cycle 1 day 1. Subjects will be followed until death, lost to follow-up, or withdrawal of consent.


Information By: Vector Oncology

Dates:
Date Received: April 6, 2011
Date Started: April 2011
Date Completion: April 2017
Last Updated: January 16, 2017
Last Verified: January 2017