At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 316 enrolled
Drug / intervention
Lurbinectedin +1 moredrug
Likely dose
Lurbinectedin 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Pretreated Patients With Selected Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Lurbinectedin and Irinotecan for Advanced Solid Tumors and 11 related conditions. Completed, enrolled 316 participants across 23 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma, Epithelial Ovarian Carcinoma, Mesothelioma, Gastroenteropancreatic Neuroendocrine Tumor, SCLC, Gastric Carcinoma, Pancreatic Adenocarcinoma, Colorectal Carcinoma, Neuroendocrine Tumors
CountriesFrance, Germany, Italy, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartMay 2016
Primary CompletionJul 2025
TodayJul 2026
First PostedNov 20, 2015
Enrollment StartMay 6, 2016
Primary CompletionJul 1, 2025
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 10.6 years ago
Interventions
Lurbinectedindrug
lurbinectedin (PM01183) 4 mg vials
Irinotecandrug
irinotecan 40 mg, 100 mg or 300 mg vials