NCT01956812

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Metastatic Pancreatic Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	IMMU-107	Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
DRUG	placebo	placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
DRUG	Gemcitabine	Gemcitabine, 200 mg/m2, given weekly x 4 in both arms

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-10-08
• Last updated: 2021-08-16

Locations

64 sites across 8 countries: United States, Austria, Belgium, Canada, France, Israel, Poland, Spain