Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

Recruiting in Palo Alto (17 mi)

+58 other locations

Overseen byMitesh Borad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Threshold Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

At least 18 years of age

Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Radiosensitizing doses of 5-fluorouracil;

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Treatment Details

Interventions

Gemcitabine (Anti-metabolite)
TH-302 (Alkylating agent)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: 340 mg/m2 TH-302 + GemcitabineExperimental Treatment2 Interventions

TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle. Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Group II: 240 mg/m2 TH-302 + GemcitabineExperimental Treatment2 Interventions

TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Group III: GemcitabineActive Control1 Intervention

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: