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Clinical Trials/EUCTR2012-002957-42-DE
EUCTR2012-002957-42-DE
Active, not recruiting
Phase 1

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

Threshold Pharmaceuticals0 sites660 target enrollmentStarted: April 29, 2013Last updated:
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Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
660
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •\- At least 18 years of age.
  • •\- Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by
  • •histology or cytology and previously untreated with chemotherapy or systemic therapy
  • •\- Measurable disease (at least one target lesion outside of previous radiation fields) or
  • •non\-measurable disease by RECIST 1\.1 criteria (see Appendix III).
  • •\- Documentation of disease progression since any prior therapy.
  • •\- Life expectancy of at least 3 months.
  • •\- Acceptable liver function.
  • •\- Acceptable renal function.
  • •\- Acceptable hematologic status.

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
  • •6\. Major surgery, other than diagnostic surgery, \=28 days prior to the date of randomization.

Investigators

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