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

Conditions

Pancreatic Cancer

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.