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3P-14-1: 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

Description

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.

Phase

Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.

Inclusion and Exclusion 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

  • 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

Sites

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