A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer

February 28, 2007 updated by: Millennium Pharmaceuticals, Inc.

A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer

This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.

Study Type

Interventional

Enrollment

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

Each subject must meet the following inclusion criteria to be eligible for enrollment in the study:

  • Histologic diagnosis (recent or remote) of prostate adenocarcinoma

  • Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following:

    • Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
    • Progressive bone metastasis (presence of new lesion(s) on a bone scan)
    • Progressive PSA levels despite castrate levels of testosterone
    • Patients who have received an anti-androgen must have shown progression of disease off of the anti-androgen prior to enrollment
  • Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate)
  • LHRH (Luteinizing Hormone-Releasing Hormone)analog therapy:
  • If subject is being treated with LHRH analog therapy at the time of screening the therapy must be maintained for the duration of the trial.
  • If subject discontinued LHRH therapy prior to screening, the therapy must be discontinued ≥10 weeks prior to enrollment for 1 month depot preparations, 24 weeks for 3 month depot preparations, and 32 weeks for 4 month depot preparations.
  • Agree to use an effective method of barrier contraception. Effective method of barrier contraception includes a condom with spermicidal jelly, a diaphragm with spermicidal jelly, or abstinence.

Exclusion Criteria

Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment
  • Use of PC-SPES (herbal supplement) within 4 weeks of enrollment
  • Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment
  • Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment
  • Prior monoclonal antibody administration, including Prostacint®
  • Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC)
  • History of CNS metastasis, including epidural disease
  • History of seizure disorder requiring active treatment and/or stroke
  • History of HIV infection
  • Platelet count ≤100,000/mm3
  • Absolute neutrophil count (ANC) ≤1,500/mm3
  • Hematocrit ≤30 percent
  • Abnormal coagulation profile (PT, and/or INR, PTT)
  • Creatinine clearance <60 mL/min or Serum creatinine >2.0 mg/dL
  • AST or ALT >1.5 X ULN
  • Bilirubin (total) >ULN
  • Serum calcium ≥12.5 mg/dL
  • Active serious infection not controlled by antibiotics
  • Active angina pectoris or NY Heart Association Class III-IV heart disease
  • Karnofsky Performance Status <60
  • Life expectancy <6 months
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Registration Dates

First Submitted

January 21, 2003

First Submitted That Met QC Criteria

January 21, 2003

First Posted (Estimate)

January 22, 2003

Study Record Updates

Last Update Posted (Estimate)

March 1, 2007

Last Update Submitted That Met QC Criteria

February 28, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M59102-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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