Clinical trial NCT00808418: A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
Official title: A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate
cancer
metastatic
castration
refractory
elesclomol
sodium
docetaxel
prednisone
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.

Detailed description: This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.

Eligibility criteria: Inclusion Criteria

* Confirmed metastatic prostate cancer
* No more than one prior chemotherapy on which the disease progressed
* ECOG performance status of less than or equal to 2
* Adequate bone marrow, renal and hepatic functions as defined in the protocol
* Neuropathy less than or equal to 2
* Reliable venous access for frequent study drug infusions

Exclusion Criteria

* Significant cardiovascular disease
* Known active brain metastases
* Subjects that have received treatment for other malignancies with in the past 5 years
* Other clinically significant uncontrolled conditions

Primary outcomes:
measure: To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
timeFrame: Jan 2011
measure: To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
timeFrame: Jan 2011
measure: To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
timeFrame: Jan 2011
Secondary outcomes:
measure: To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer
timeFrame: Jan 2011
measure: Evaluate OS
timeFrame: Jan 2011
measure: To characterize the pharmacokinetics of elesclomol metabolites
timeFrame: Jan 2011
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Maryland
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: San Antonio
country: United States
facility: University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
References: