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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.

Detailed Summary: This is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.
Sponsor: Vector Oncology

Current Primary Outcome: 12-week Progression Free Rate [ Time Frame: Assessed after 12 weeks of study treatment ]

Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.


Original Primary Outcome: 12-week Progression Free Rate [ Time Frame: Assessed after 12 weeks of study treatment ]

Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines verison 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.


Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: Date of Consent until progression or death, up to 27 months ]
    PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.
  • Best Overall Response [ Time Frame: Date of consent until end of study treatment, up to 32 months ]
    Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
  • Duration of Response [ Time Frame: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression ]
    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.
  • Overall Survival (OS) [ Time Frame: Date of Consent until death, up to 32 months ]
    OS was measured from date of consent until time of death from any cause, up to 32 months.


Original Secondary Outcome:

  • 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 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 24 months.
  • Response Rate (RR) [ Time Frame: Cycle 1 Day 1 until end of study treatment ]
    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1.
  • Duration of Response [ Time Frame: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression ]
    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.
  • Overall Survival (OS) [ Time Frame: Cycle 1 Day 1 up to 24 months after the end of study treatment ]
    The time origin for OS will be Cycle 1 Day 1. Subjects will be followed for up to 24 months after the end of treatment or until death, lost to follow-up, or withdrawal of consent, whichever occurs first.


Information By: Vector Oncology

Dates:
Date Received: January 6, 2012
Date Started: March 2012
Date Completion:
Last Updated: December 29, 2016
Last Verified: March 2016