Pancreatic Cancer Research

Clinical trialPhase 1Terminated

Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Outcome
Stopped earlyThe trial has been terminated earlier following the company decision to discontinue the clinical development of Evofosfamide (Business decision)
Phase
Phase 1
Status
Terminated
Study type
Interventional
Start
January 2014
Expected end
May 2016
Enrollment
19 participants
Sites
5
Primary outcomes
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
Sponsor
Industry
Results posted
2017-12-15
Last update
11 May 2025

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Brief summary public domain (ClinicalTrials.gov)

This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Subjects Experiencing Dose Limiting Toxicity (DLT) [Up to Day 28 of Cycle 1]. Count Of Participants, Participants. TH-302 Plus Nab-paclitaxel Plus Gemcitabine (n=18): 1.