NCT00052000

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2003

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

January 21, 2003

Last Update Submit

February 28, 2007

Conditions

Prostate Cancer

Interventions

MLN2704 (DM1 conjugated monoclonal antibody MLN591)DRUG

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2003

First Posted

January 22, 2003

Study Start

November 1, 2002

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

US(2)