MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

NCT00070837 | Completed Phase 1

• 1 other identifier: M59102-051
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times 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, broken down and eliminated by the body.

Conditions

Prostatic Neoplasms

Interventions

MLN2704 (DM1 conjugated monoclonal antibody MLN591) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma
• Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma
• years of age or older
• Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone \<50 ng/dL):
• 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 (as defined in Section 3.6.1)
• Subjects who have received an anti-androgen must have shown progression of disease following discontinuation of the anti-androgen
• Subjects must remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration of the trial unless surgically castrate
• Agree to use an effective barrier method of contraception.

You may not qualify if:

• Testosterone \>50 ng/dL
• Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of dosing
• Use of PC-SPES within 4 weeks of dosing
• Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of dosing
• Use of anti-androgen therapy (eg, flutamide, bicalutamide, nilutamide) within 6 weeks of dosing
• Prior monoclonal antibody administration, including Prostascint®
• Peripheral neuropathy of \> Grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE)
• History of CNS metastasis, including incompletely treated epidural disease
• History of Hepatitis B or C
• 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 \<27 percent
• Abnormal coagulation profile (elevated PT, and/or INR, PTT)

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (4)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Medical College of Cornell University/ New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Duke University Medical Center, Box 3532

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic, Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 8, 2003
• First Posted: October 13, 2003
• Study Start: October 1, 2003
• Study Completion: October 1, 2004
• Last Updated: July 13, 2007

Record last verified: 2007-07

Locations

US (4)