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(EMR 200592-001)
- Conditions
- Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
- Registration Number
- JPRN-jRCT2080222461
- Lead Sponsor
- Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 660
1.At least 18 years of age (At least 20 years of age in Japan)
2.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;
- Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy;
3.Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
4.Documentation of disease progression since any prior therapy
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6.Life expectancy of at least 3 months
7.Acceptable liver, renal function and acceptable hematological status
8.Other protocol defined inclusion criteria may apply
- 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
- Symptomatic ischemic heart disease
- Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
- 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
- Severe chronic obstructive or other pulmonary disease with hypoxemia
- Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
- Prior therapy with a hypoxic cytotoxin
- Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
- Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
- Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
- Other protocol defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method