QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03132155|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : November 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Sarcoma||Drug: AMG 337||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 (EWSR1-ATF1) Gene Fusion|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: AMG 337
AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma
Drug: AMG 337
- 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 by BICR.
- 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.
- Progression-free Survival (PFS) [ Time Frame: 1 year ]To determine PFS, evaluated in accordance with RECIST Version 1.1 BICR.
- 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.
- Duration of Response (DOR) [ Time Frame: 1 year ]To determine DOR, measured by RECIST Version 1.1 by BICR.
- Disease Control Rate (DCR) [ Time Frame: 4 months ]To determine DCR (confirmed CR, PR, or SD) lasting for at least 4 months by BICR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132155
|United States, California|
|Chan Soon-Shiong Institute for Medicine|
|El Segundo, California, United States, 90245|
|United States, Texas|
|The University of Texas, MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|