At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Irinotecan +4 moredrug
Likely dose
Irinotecan 70 mg/m2from 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.
A Randomized Multi-center Phase I/II Trial of ICM (Irinotecan, Cisplatin, Mitomycin C) With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 15, 2011·Updated Mar 22, 2016
In Brief
A Phase 1 clinical trial evaluating Irinotecan, Cisplatin, and 3 other interventions for Pancreatic Cancer. Completed, enrolled 18 participants across 2 sites.
Detailed Summary
Patients whose pancreatic cancers have defects in the BRCA/Fanconi DNA repair pathway or other defects in homologous repair will have cancers that respond to olaparib when given in combination with the DNA damaging agents, irinotecan, cisplatin, mitomycin C (ICM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionJan 2014
Study CompletionFeb 2016
TodayJul 2026
First PostedFeb 15, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2014
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.4 years ago
Interventions
Irinotecandrug
Irinotecan 70 mg/m2 IV, Days 1 and 8
Cisplatindrug
Cisplatin 25 mg/m2 IV, Days 1 and 8
Olaparib (for levels 1 and 5)drug
Olaparib 100 mg bid oral, Days 1 and 8
Olaparib (for dose level 2)drug
Olaparib 100mg bid oral, Day 1-3, Day 8-10
Mitomycin-Cdrug
Mitomycin 5 mg/m2 IV, Day 1