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 range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.