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 September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01283373
First received: January 21, 2011
Last updated: September 2, 2014
Last verified: September 2014

January 21, 2011
September 2, 2014
March 2011
June 2016   (final data collection date for primary outcome measure)
Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01283373 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: DSTP3086S
Escalating intravenous dose
Experimental: A
Intervention: Drug: DSTP3086S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
67
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Reference Study ID Number: DST4964g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01283373
DST4964g, GO00768
Not Provided
Genentech
Genentech
Not Provided
Study Director: Bernard Fine, M.D. Genentech
Genentech
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP