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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00808418
First received: December 12, 2008
Last updated: January 31, 2014
Last verified: January 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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 ]

Enrollment: 34
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Corp.
ClinicalTrials.gov Identifier: NCT00808418     History of Changes
Other Study ID Numbers: 4783-12
Study First Received: December 12, 2008
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
prostate
cancer
metastatic
castration
refractory
elesclomol
sodium
docetaxel
prednisone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 10, 2014