A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer
This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc.
First received: January 21, 2003
Last updated: February 28, 2007
Last verified: February 2007
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.
Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer
| Estimated Enrollment:
| Study Start Date:
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Each subject must meet the following inclusion criteria to be eligible for enrollment in the study:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052000
|The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins
|Baltimore, Maryland, United States, 21231 |
|Memorial Sloan-Kettering Cancer Center
|New York, New York, United States, 10021 |
Millennium Pharmaceuticals, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 21, 2003
||February 28, 2007
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists