Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma

NCT00399113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-07-14

No results posted yet for this study

Summary

The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.

Conditions

Interventions

DRUG

188Re-PTI-6D2

monoclonal antibody

Sponsors & Collaborators

  • Pain Therapeutics

    lead INDUSTRY

Principal Investigators

  • Eithan Galun, M.D. · Hadassah Hebrew University Hospital

  • Jacob Schachter, M.D. · Chaim Sheba Medical Center

  • Tzila Zwas, M.D. · Chaim Sheba Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-06-30

Countries

  • Israel

Study Locations

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Entities

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 NCT00399113 on ClinicalTrials.gov