Clinical trialPhase 3Terminated
Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)
- Outcome
- Stopped earlyThe DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo. (Other)
- Phase
- Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- December 2013
- Expected end
- November 2016
- Enrollment
- 334 participants
- Sites
- 64
- Primary outcomes
- overall survival
- Sponsor
- Industry
- Results posted
- No
- Last update
- 16 August 2021
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Brief summary public domain (ClinicalTrials.gov)
The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).
Papers 6
- BackgroundMapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic duc… DOI 10.1186/1476-4598-12-143↗
- BackgroundPAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. DOI 10.1002/cncr.27762↗
- BackgroundFractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced panc… DOI 10.1002/cncr.27592↗
- BackgroundFirst-line treatment of metastatic pancreatic cancer. DOI 10.6092/1590-8577/722↗
- BackgroundTreatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. DOI 10.1158/1078-0432.ccr-10-2579↗
- BackgroundCombination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human… DOI 10.1158/1535-7163.mct-11-0115↗