A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects With Castration-Resistant Prostate Cancer (CRPC)

Astellas Pharma Inc4 sites in 1 country46 target enrollmentStarted: October 2010Last updated: June 7, 2013

ConditionsProstate Neoplasms

InterventionsASG-5ME

DrugsASG-5ME

Overview

Phase: Phase 1
Status: Completed
Sponsor: Astellas Pharma Inc
Enrollment: 46
Locations: 4
Primary Endpoint: Safety assessed by recording of adverse events, laboratory assessments and vital signs

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).

Detailed Description

The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: Male
Accepts Healthy Volunteers: No

Inclusion Criteria

•Subject has histologically-confirmed castration-resistant prostate cancer and meets at least 1 of the following criteria:
•subject's disease has progressed on or after available standard therapy -OR-
•there is no effective standard therapy available for treating the subject's disease -OR-
•subject or his disease is not suitable for standard therapy -OR-
•subject chooses to defer or decline standard therapy (subject is adequately informed of the availability of clinically meaningful therapy and chooses instead to partake in this research using a product with no documented clinical activity)
•Testosterone ≤ 50 ng/dL
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy of \> 6 months as evaluated and documented by the investigator
•Hematologic function, as follows (no red blood cell (RBC) or platelet transfusions are allowed within 4 weeks of the first dose of ASG-5ME):
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

Exclusion Criteria

•History of central nervous system metastasis, including incompletely treated epidural disease
•History of other primary malignancy (including premalignant myeloid malignancy e.g. myelodysplastic syndrome), unless:
•Curatively resected non-melanomatous skin cancer
•Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
•Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outsubject medication
•The following treatments are not allowed within 4 weeks of enrollment: cytotoxic chemotherapy, radiation therapy or the dietary supplement PC-SPES
•Use of prednisone (or equivalent corticosteroids) \> 20 mg/day are not allowed. Doses \< 20 mg/day are allowed only if they have been at the same dose for \> 4 weeks
•Use of anti-androgen therapy (ie, flutamide, bicalutamide and nilutamide) within 6 weeks of study enrollment; non-responders to second-line anti-androgen therapy do not require the 6 week withdrawal period
•Monoclonal antibody therapy within 3 months of enrollment with the exception of denosumab (prior or concurrent use of denosumab is allowed)
•Peripheral neuropathy of ≥ grade 2 as defined by the CTCAE criteria version 4.0