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A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Days 1-21

Safety Issue:

No

Principal Investigator

Bernard Fine, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

DST4964g

NCT ID:

NCT01283373

Start Date:

March 2011

Completion Date:

November 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Albany, New York  12208
Seattle, Washington  98195
Flint, Michigan  48532