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Clinical Trials/JPRN-jRCT2080222461
JPRN-jRCT2080222461
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(EMR 200592-001)

Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)0 sites660 target enrollmentStarted: April 15, 2014Last updated:
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Overview

Phase
Phase 3
Status
Completed
Sponsor
Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)
Enrollment
660
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •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

Exclusion Criteria

  • •\- 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

Investigators

Sponsor
Merck KGaA, (in all countries except the US and Japan), EMD Serono, Inc., (in the US), Meck Serono Co., Ltd. (in Japan)

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