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 ]
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