Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitab… (NCT01144455) | Clinical Trial Compass
CompletedPhase 2
Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma
United States214 participantsStarted 2010-06
Plain-language summary
The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 18 years of age
✓. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
✓. Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven either by histology or cytology previously untreated with chemotherapy or systemic therapy other than:
✓. Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields)
✓. Documentation of disease progression since any prior therapy
✓. ECOG performance status of 0 or 1
✓. Life expectancy of at least 3 months
✓. Acceptable liver function:
Exclusion criteria
✕. New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
✕. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
✕. Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
✕
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
. 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
✕. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery