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 - Full Text View

Sponsored by:	Synta Pharmaceuticals, Corp.
Information provided by:	Synta Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:	NCT00808418

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Elesclomol Sodium Drug: Docetaxel	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)

Further study details as provided by Synta Pharmaceuticals, Corp.:

Primary Outcome Measures:

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 [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer [ Time Frame: Jan 2011 ] [ Designated as safety issue: No ]
Evaluate OS [ Time Frame: Jan 2011 ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics of elesclomol metabolites [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	34
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort: Experimental	Drug: Elesclomol Sodium Chemotherapy agent Drug: Docetaxel Chemotherapy agent

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808418

Locations

United States, California
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States, 92708
United States, Maryland
Mayo Clinic
Rochester, Maryland, United States, 55905
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
United States, Texas
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Synta Pharmaceuticals, Corp.

More Information

No publications provided

Responsible Party:	Synta Pharmaceuticals ( David Hynds, Clinical Trials Manager )
Study ID Numbers:	4783-12
Study First Received:	December 12, 2008
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00808418 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals, Corp.:

prostate
cancer
metastatic
castration
refractory

elesclomol
sodium
docetaxel
prednisone

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Docetaxel
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009