NL-OMON40361
Completed
Phase 3
A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma - MAESTRO study
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck
- Enrollment
- 15
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1\. At least 18 years of age.
- •2\. Ability to understand the purposes and risks of the trial and has signed a written informed consent form approved by the investigator\*s Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •3\. Locally advanced unresectable or metastatic pancreatic ductal 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 or adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy.
- •4\. Measurable disease (at least one target lesion outside of previous radiation fields) or non\-measurable disease by RECIST 1\.1 criteria.
- •5\. Documentation of disease progression since any prior therapy.
- •6\. ECOG performance status of 0 or 1\. Two observers must assess performance status \<\=5 days prior to randomization. If discrepant, the poorer performance status is used.
- •7\. Life expectancy of at least 3 months.
- •8\. Acceptable liver function: bilirubin \<\=1\.5 times upper limit of normal (ULN) (not applicable to subjects with Gilbert\*s syndrome) and aspartate aminotransferase (AST \[SGOT]) and alanine aminotransferase (ALT \[SGPT]) \<\=3 times ULN (if liver metastases are present, then \<\=5 times ULN is allowed).
- •9\. Acceptable renal function: serum creatinine \<\=1\.5 times ULN or calculated creatinine clearance \>\=60 mL/min (Cockcroft\-Gault formula).
- •10\. Acceptable hematologic status (without growth factor support or transfusion dependency): absolute neutrophil count (ANC) \>\=1500 cells/µL, platelet count \>\=100,000/µL, hemoglobin \>\=9\.0 g/dL.
Exclusion Criteria
- •1\. New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease.
- •2\. Symptomatic ischemic heart disease.
- •3\. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months).
- •4\. Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non\-melanoma skin cancer or pre\-invasive cancer of the cervix.
- •5\. Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia, or oxygen saturation \<90% by pulse oximetry after a 2\-minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia.
- •6\. Major surgery, other than diagnostic surgery, \<\=28 days prior to the date of randomization. Subject must have completely recovered from surgery.
- •7\. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •8\. Treatment of pancreatic cancer with radiation therapy or surgery \<\=28 days prior to the date of randomization.
- •9\. Prior therapy with a hypoxic cytotoxin.
- •10\. Subjects who participated in an investigational drug or device trial \<\=28 days prior to Day 1 of the first cycle.
Investigators
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