A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01283373
First received: January 21, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S a dministered as a single agent by intravenous (IV) infusion to patients with meta static Castration-Resistant Prostate Cancer (CRPC).


Condition Intervention Phase
Prostate Cancer
Drug: DSTP3086S
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration-time curve [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Maximum and minimum concentrations [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Clearance [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Half-life [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Volume of distribution [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dose escalation cohorts
Drug: DSTP3086S
Escalating intravenous dose
Experimental: B
Dose expansion cohorts
Drug: DSTP3086S
DSTP3086S administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Histologic documentation of adenocarcinoma of the prostate
  • Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
  • Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
  • For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting
  • Evaluable or measurable disease
  • Documented willingness to use an effective means of contraception

Exclusion Criteria:

  • Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1
  • Major surgical procedure within 4 weeks prior to Day 1
  • Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
  • Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent
  • Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is >/= 8 weeks since completion of radiotherapy and >/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants
  • Dose expansion cohort (B): no prior chemotherapy is allowed
  Contacts and Locations
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: NCT01283373

Contacts
Contact: Reference Study ID Number: DST4964g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
San Francisco, California, United States, 94115
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Washington
Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Bernard Fine, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01283373     History of Changes
Other Study ID Numbers: DST4964g, GO00768
Study First Received: January 21, 2011
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014