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A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00052000•Millennium Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

All ages

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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.
+1 more criteria

Exclusion Criteria

•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
+12 more criteria

Locations (2)

The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins

Baltimore, Maryland, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

November 1, 2002

Last Updated

March 1, 2007

Enrollment

Estimated participants

Conditions

Prostate Cancer

Interventions

MLN2704 (DM1 conjugated monoclonal antibody MLN591)

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC