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A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer

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)

NCT01228760•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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
+10 more criteria

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
+5 more criteria

Locations (4)

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

The Karmanos Cancer Institute

Detriot, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Wisconsin Madison, Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

June 7, 2013

Enrollment

ACTUAL participants

Conditions

Prostate Neoplasms

Interventions

ASG-5ME

DRUG

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

NCT03181867

Prostate NeoplasmsProstatic Cancer+3 more

View study

TERMINATEDNA

Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator

NCT00999960

Prostatic NeoplasmsCancer of Prostate+2 more

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: June 7, 2013Data 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 Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator

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