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Spots Global Cancer Trial Database for Safety and Efficacy Study of 90Y-hPAM4 at Different Doses

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Trial Identification

Brief Title: Safety and Efficacy Study of 90Y-hPAM4 at Different Doses

Official Title: A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer

Study ID: NCT00597129

Interventions

90Y-hPAM4

Study Description

Brief Summary: Safety study to determine highest dose of 90Y-hPAM4 can be safety administered

Detailed Description: radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4 in this population. Secondary objectives include the assessment of tumor targeting, biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4, as determined by development of human anti-humanized antibodies (HAHA), and to obtain preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Goshen Cancer Center, Goshen, Indiana, United States

Nebraska Medical Center, Omaha, Nebraska, United States

University of Medicine and Dentistry, Newark, New Jersey, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Contact Details

Name: William Wegener, MD, PhD

Affiliation: Gilead Sciences

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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