Clinical trialPhase 1 / Phase 2Completed
Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer
A Phase Ib/II Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- January 2008
- Expected end
- December 2013
- Enrollment
- 80 participants
- Sites
- 11
- Primary outcomes
- safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
- Sponsor
- Industry
- Results posted
- No
- Last update
- 16 August 2021
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Brief summary public domain (ClinicalTrials.gov)
This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.