QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma (NCT03132155) | Clinical Trial Compass
TerminatedPhase 2
QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma
Stopped: Prematurely terminated due to lack of therapeutic effect
United States8 participantsStarted 2018-08-29
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
✓. Able to attend required study visits and return for adequate follow-up, as required by this protocol.
✓. Able to self-administer AMG 337 as a whole capsule by mouth every day.
✓. Age ≥ 16 years.
✓. Histologically confirmed, unresectable, locally advanced or metastatic tumors that contain the EWSR1-ATF1 gene fusion, as determined by fluorescent in situ hybridization (FISH) or other diagnostic methods and confirmed by RNA sequencing (RNAseq).
✓. Have measurable disease evaluable in accordance with RECIST Version 1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Must have a recent Formalin-fixed paraffin-embedded (FFPE) tumor biopsy specimen that was obtained following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
Exclusion criteria
✕. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
✕. Inability to attend required study visits and return for adequate follow-up, as required for this protocol.
. Known hypersensitivity to any component of the study medication(s).
✕. Women who are nursing, pregnant, or planning to become pregnant during the duration of the study.
✕. Current diagnosis or history of a second neoplasm, except the following:
✕. History of bleeding diathesis.
✕. Uncontrolled hypertension (systolic \> 160 mmHg and/or diastolic \> 100 mmHg) or clinically significant cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months before study day 1; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
✕. Baseline ECG Fridericia's formula QTcF \> 470 ms.