A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01283373 |
Recruitment Status :
Completed
First Posted : January 26, 2011
Last Update Posted : October 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: DSTP3086S | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Dose escalation cohorts
|
Drug: DSTP3086S
Escalating intravenous dose |
Experimental: B
Dose expansion cohorts
|
Drug: DSTP3086S
DSTP3086S administered intravenously |
- Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 ]
- Area under the concentration-time curve [ Time Frame: Up to 1 year ]
- Maximum and minimum concentrations [ Time Frame: Up to 1 year ]
- Clearance [ Time Frame: Up to 1 year ]
- Half-life [ Time Frame: Up to 1 year ]
- Volume of distribution [ Time Frame: Up to 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283373
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 |
Study Director: | Bernard Fine, M.D. | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01283373 |
Other Study ID Numbers: |
DST4964g GO00768 ( Other Identifier: Hoffmann-La Roche ) |
First Posted: | January 26, 2011 Key Record Dates |
Last Update Posted: | October 4, 2016 |
Last Verified: | October 2016 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |