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

Status: Recruiting
Phase: Phase 1
Diagnosis: Gastrointestinal Malignancies, Pancreatic Cancer
NCT ID: NCT02047500 (View complete trial on
DFCI Protocol ID: 13-542


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.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Eunice Kwak, MD, Massachusetts General Hospital

Site-responsible Investigators:
Brian Wolpin, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

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
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