Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected S… (NCT02611024) | Clinical Trial Compass
CompletedPhase 1/2
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors
United States, France316 participantsStarted 2016-05-06
Plain-language summary
Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily signed and dated written informed consent prior to any specific-study procedure.
✓. Age ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
✓. Life expectancy ≥ 3 months.
✓. Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types:
✕. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year.
✕. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
✕. Myopathy or any clinical situation that causes significant and persistent elevation of CPK (\> 2.5 × ULN in two different determinations performed one week apart).
✕. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C. Known Gilbert disease.
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: 66 months
2
Recommended Dose (RD)
Timeframe: 66 months
3
Response Rate
Timeframe: At least six weeks after treatment initiation, up to 66 months