A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer

NCT ID: NCT00992745

Last Updated: 2011-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-09-30

Brief Summary

This is an open-label study comparing the imaging characteristics of 123-I-MIP-1072 and ProstaScint® (111-In-capromab pendetide)in patients with metastatic prostate cancer. Eligible patients will receive a dose of 123-I-MIP-1072 and have imaging studies and safety assessments (physical examination, vital signs, electrocardiogram, clinical laboratory tests) performed during the subsequent 24 hours. Two weeks later, patients will return for additional safety assessments and will receive ProstaScint® if they don't already have a pre-existing ProstaScint scan. Final assessments will be performed two weeks after the ProstaScint® scan unless there is a difference between the 123-I-MIP-1072 and ProstaScint® scans. If this is the case, another dose of 123-I-MIP-1072 will be given 12 weeks later, and imaging studies repeated.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Previous ProstaScint®

Subjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone.

Group Type: EXPERIMENTAL

123-I-MIP-1072

Intervention Type: DRUG

Single 10 mCi intravenous injection

123-I-MIP-1072

Intervention Type: DRUG

Single 5 mCi intravenous injection

No Previous ProstaScint®

Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.

Group Type: EXPERIMENTAL

123-I-MIP-1072

Intervention Type: DRUG

Single 10 mCi intravenous injection

111-In capromab pendetide

Intervention Type: DRUG

Single 5 mCi intravenous injection

123-I-MIP-1072

Intervention Type: DRUG

Single 5 mCi intravenous injection

Interventions

123-I-MIP-1072

Single 10 mCi intravenous injection

Intervention Type: DRUG

111-In capromab pendetide

Single 5 mCi intravenous injection

Intervention Type: DRUG

123-I-MIP-1072

Single 5 mCi intravenous injection

Intervention Type: DRUG

Other Intervention Names

Trofex; ProstaScint®; Trofex

Eligibility Criteria

Exclusion Criteria

1. Karnofsky performance status of < 50

2. Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants

3. Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment

4. Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study

5. Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment

6. Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal

7. Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study

8. Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations

9. Subject is determined by the Investigator to be clinically unsuitable for the study

10. If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Molecular Insight Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Dobkin, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Coast Imaging

Stanley Goldsmith, MD

Role: PRINCIPAL_INVESTIGATOR

NY Presbyterian Hospital - Weill Cornell Medical Center

Edward Coleman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Arif Hussain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Mack Roach, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kevin Slawin, MD

Role: PRINCIPAL_INVESTIGATOR

Vanguard Urologic Research Foundation

Samuel L Kipper, MD

Role: PRINCIPAL_INVESTIGATOR

West Coast Radiology Centerse

Locations

West Coast Radiology Centers

Laguna Niguel, California, United States

Pacific Coast Imaging

Newport Beach, California, United States

University of California - San Francisco

San Francisco, California, United States

University of Maryland

Baltimore, Maryland, United States

New York Presbyterian Hospital - Weill Cornell Medical College

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Vanguard Urologic Research Foundation

Houston, Texas, United States

Countries

United States

Other Identifiers

TX-P103

Identifier Type: -

Identifier Source: org_study_id