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Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer

NCT01956812 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2021-08-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • William Wegener, MD, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Israel
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956812 on ClinicalTrials.gov