MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen-Independent Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591)


Participation Criteria
=================
Eligibility Criteria
-----------------
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): 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |