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

NCT01144455 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	ImmunoGenesis
Phase	Phase 2
Status	COMPLETED
Enrolment	214
Start date	2010-06
Completion	2014-12

Conditions

• Pancreatic Adenocarcinoma

Interventions

• Gemzar (Gemcitabine)
• TH-302
• TH-302

Primary outcomes

• Progression-free Survival (PFS) — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Countries

United States