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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Metastatic Pancreatic Cancer, Pancreatic Cancer

In brief

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).

Key facts

Study ID

NCT01956812

Run by

Gilead Sciences

People needed

334

Starts

2013-12-01

Expected to finish

2016-11-01

Last updated by the study team

2021-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Metastatic disease
• Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
• At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
• Completed at least one cycle of the treatment
• Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
• Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
• Progression was documented,
• Preferentially radiologically by tumor growth or new lesions, or by
• Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
• KPS >/= 70
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function

You may not qualify if…

• CNS metastatic disease
• Bulky disease (any single mass >10 cm).
• >Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.
• Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
• Patients with clinically significant severe cardiorespiratory disease.
• Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Whittingham Cancer Center — Norwalk, Connecticut, United States
• Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Mountain States Tumor Institute at St. Luke's Regional Medical Center — Boise, Idaho, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Indiana University Health Goshen Center for Cancer Care — Goshen, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Ashland-Bellefonte Cancer Center — Ashland, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• New York Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Banner MD Anderson — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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