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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283373
• Other study ID #: DST4964g
• Secondary ID: GO00768
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2011
• Last updated: October 3, 2016
• Start date: March 2011
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• DSTP3086S
DSTP3086S administered intravenously
• DSTP3086S
Escalating intravenous dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Days 1-21	No
Secondary	Area under the concentration-time curve		Up to 1 year	No
Secondary	Maximum and minimum concentrations		Up to 1 year	No
Secondary	Clearance		Up to 1 year	No
Secondary	Half-life		Up to 1 year	No
Secondary	Volume of distribution		Up to 1 year	No