MedDataX Logo

MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

NCT ID: NCT00070837

Last Updated: 2007-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma
* Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma
* 18 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):

1. Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
2. Progressive bone metastasis (presence of new lesion(s) on a bone scan)
3. 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.

Exclusion Criteria

* 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)
* Serum creatinine \>2.0 mg/dL, or creatinine clearance \<60 mL/min if serum creatinine \>2.0 mg/dL
* AST or ALT \>1.5 x ULN
* Bilirubin (total) \>1.25 x 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Weill Medical College of Cornell University/ New York Presbyterian Hospital

New York, New York, United States

Site Status

Duke University Medical Center, Box 3532

Durham, North Carolina, United States

Site Status

Cleveland Clinic, Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M59102-051

Identifier Type: -

Identifier Source: org_study_id

NCT00074347

Identifier Type: -

Identifier Source: nct_alias