At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 214 enrolled
Drug / intervention
Gemzar (Gemcitabine) +2 moredrug
Likely dose
Gemzar (Gemcitabine) 1,000 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 Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Gemzar (Gemcitabine) and TH-302 for Pancreatic Adenocarcinoma. Completed, enrolled 214 participants across 59 sites.
Detailed Summary
The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Adenocarcinoma
CountriesUnited States
CollaboratorsPRA Health Sciences
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionSep 2013
Study CompletionDec 2014
TodayJul 2026
First PostedJun 15, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.0 years ago
Interventions
Gemzar (Gemcitabine)drug
1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
TH-302drug
240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
TH-302drug
340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.