Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas (NCT02503423) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
United States253 participantsStarted 2015-07-14
Plain-language summary
This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
✓. Men and women 18 years of age or older.
✓. Participants with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available. Specific tumor types that will be selected for study in Phase 2 are detailed in the protocol.
✓. For Phase 2 Cohorts 3 and 4, participants must have evidence of documented progressive disease and must have received at least two prior systemic therapies.
✓. Participants with CD30-positive lymphoma must have received, be ineligible for, or intolerant to brentuximab vedotin, provided that brentuximab vedotin is locally approved and available.
✓. Participants with mycosis fungoides or Sezary syndrome must have received, be ineligible or intolerant to mogamulizumab, provided that mogamulizumab is locally approved and available.
✓. In the Phase 2 portion of the protocol only, participants must have measurable disease according to response criteria appropriate for their type of cancer.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion criteria
✕. Hypersensitivity to ASTX660, excipients of the drug product, or other components of the study treatment regimen.
What they're measuring
1
Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results
. Poor medical risk because of systemic diseases (e.g. active uncontrolled infections) in addition to the qualifying disease under study.
✕. Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participant safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of ASTX660.
✕. History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
✕. Abnormal left ventricular ejection fraction (LVEF; \<50%) or echocardiogram ECHO or multiple gated acquisition scan (MUGA).
✕. Congestive cardiac failure of \>= Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as participants with marked limitation of activity and who are comfortable only at rest.
✕. Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
✕. History or presence of complete left bundle branch block, heart block, cardiac pacemaker or significant arrhythmia.