NCT03132155

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NantPharma, LLC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 description

The phase 2 single arm study will assess efficacy of AMG 337 (based on confirmed ORR) in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion, as determined by fluorescent in situ hybridization (FISH) or other diagnostic methods and confirmed by RNA sequencing (RNAseq).

Conditions

• Clear Cell Sarcoma

Interventions

Type	Name	Description
DRUG	AMG 337	6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)

Timeline

• Start date: 2018-08-29
• Primary completion: 2021-08-13
• Completion: 2021-09-21
• First posted: 2017-04-27
• Last updated: 2024-05-24
• Results posted: 2024-05-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study