Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: TH-302; Nab-paclitaxel; Gemcitabine
Intervention description: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.; Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.; Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TH-302; Nab-paclitaxel; Gemcitabine; Evofosfamide

Summary:

      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.
    

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