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

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Subjects greater than or equal to (>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than: - Radiosensitizing doses of 5-fluorouracil; - Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine; - Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection; - Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy - Subjects may have measurable or non-measurable disease according to RECIST 1.1. - Eastern cooperative oncology group (ECOG) performance status of 0 or 1 - Acceptable hematological status, liver and renal function as defined in the protocol - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Significant cardiac or peripheral vascular arterial disease - Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months) - Severe chronic obstructive or other pulmonary disease with hypoxemia - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy - Subjects receiving concomitant treatment with radiotherapy or other investigational drugs - Other protocol defined exclusion criteria could apply

Last updated:

5/2/2014

NCT ID:

NCT02047500

IRB Number:

13-007128