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

• ClinicalTrials.gov Identifier: NCT01283373
• Recruitment Status: Completed
• First Posted: January 26, 2011
• Last Update Posted: October 4, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: DSTP3086S	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: March 2011
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Dose escalation cohorts	Drug: DSTP3086S; Escalating intravenous dose
Experimental: B; Dose expansion cohorts	Drug: DSTP3086S; DSTP3086S administered intravenously

Outcome Measures

Primary Outcome Measures :

1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 ]

Secondary Outcome Measures :

1. Area under the concentration-time curve [ Time Frame: Up to 1 year ]
2. Maximum and minimum concentrations [ Time Frame: Up to 1 year ]
3. Clearance [ Time Frame: Up to 1 year ]
4. Half-life [ Time Frame: Up to 1 year ]
5. Volume of distribution [ Time Frame: Up to 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, California

San Francisco, California, United States, 94115

United States, Illinois

Chicago, Illinois, United States, 60637

United States, Michigan

Detroit, Michigan, United States, 48201

United States, New York

New York, New York, United States, 10065

United States, Washington

Seattle, Washington, United States, 98195

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Bernard Fine, M.D.; Genentech, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Danila DC, Szmulewitz RZ, Vaishampayan U, Higano CS, Baron AD, Gilbert HN, Brunstein F, Milojic-Blair M, Wang B, Kabbarah O, Mamounas M, Fine BM, Maslyar DJ, Ungewickell A, Scher HI. Phase I Study of DSTP3086S, an Antibody-Drug Conjugate Targeting Six-Transmembrane Epithelial Antigen of Prostate 1, in Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3518-3527. doi: 10.1200/JCO.19.00646. Epub 2019 Nov 5.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01283373
• Other Study ID Numbers: DST4964g; GO00768 ( Other Identifier: Hoffmann-La Roche )
• First Posted: January 26, 2011
• Last Update Posted: October 4, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases