MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

Millennium Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00070837

M59102-051

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.