Clinical Trial: QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma That Contains the Ewing Sarcoma Breakpoint Region 1-activating Transcription Factor-1

Brief Summary: This is a phase 2 study that will assess the efficacy of AMG 337 in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion.

Detailed Summary: The phase 2 study will assess efficacy of AMG 337 in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion. The study will be conducted using Simon's two-stage optimal design. The null hypothesis of Simon's two-stage design states that the ORR will be ≤ 40% (poor response) and will be tested against a one-sided alternative.
Sponsor: NantPharma, LLC

Current Primary Outcome: Phase 2 Primary Endpoint - Objective Response Rate (ORR) [ Time Frame: 1 year ]

Confirmed ORR (confirmed complete response or partial response) will be evaluated in accordance with RECIST Version 1.1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Phase 2 Secondary Endpoint - Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability) [ Time Frame: 1 year ]
    To evaluate the safety of AMG 337 based on grade 3 or 4 non-hematologic toxicity.
  • Phase 2 Secondary Endpoint - Progression-free Survival (PFS) [ Time Frame: 1 year ]
    To determine PFS, defined as the time from the date of first administration of therapy to the date of disease progression or de
  • Phase 2 Secondary Endpoint - Overall Survival (OS) [ Time Frame: 1 year ]
    To determine OS, defined as the time from the date of the first administration of therapy to the date of death.
  • Phase 2 Secondary Endpoint - Duration of Response [ Time Frame: 1 year ]
    To determine the duration of response, defined as the time from first response (PR or CR) until the date of disease progression or death, whichever occurs first
  • Phase 2 Secondary Endpoint - Disease Control Rate [ Time Frame: 4 months ]
    To determine disease control rate defined as confirmed CR, PR, or stable disease lasting for at least 4 months


Original Secondary Outcome: Same as current

Information By: NantPharma, LLC

Dates:
Date Received: April 20, 2017
Date Started: May 2017
Date Completion: December 2019
Last Updated: April 26, 2017
Last Verified: April 2017