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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

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Trial Information

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


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 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

- Measurable disease (at least one target lesion outside of previous radiation fields)
or non-measurable disease by RECIST v.1.1 criteria

- Documentation of disease progression since any prior therapy

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least 3 month

- Acceptable liver, renal function and acceptable hematological status

- Other protocol defined inclusion criteria may apply

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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

Overall survival time is defined as time from randomization to death or last day known to be alive.

Outcome Time Frame:

Anticipated up to 4 years

Safety Issue:

No

Principal Investigator

Robert J. Fram, MD, FACP

Investigator Role:

Study Director

Investigator Affiliation:

EMD Serono Inc., an Affiliate of Merck KGaA, Darmstadt, Germany

Authority:

United States: Food and Drug Administration

Study ID:

EMR 200592-001

NCT ID:

NCT01746979

Start Date:

December 2012

Completion Date:

May 2016

Related Keywords:

  • Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
  • TH-302; Pancreatic Cancer; EMR200592-001
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Please Contact U.S. Medical Information Located inRockland, Massachusetts