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

NCT00808418 | Completed Phase 1

• 1 other identifier: 4783-12
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; metastatic; castration; refractory; elesclomol; sodium; docetaxel; prednisone

Outcome Measures

Primary Outcomes (3)

• 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

  Jan 2011

• To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel

  Jan 2011

• To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population

  Jan 2011

Secondary Outcomes (3)

• To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer

  Jan 2011

• Evaluate OS

  Jan 2011

• To characterize the pharmacokinetics of elesclomol metabolites

  Jan 2011

Study Arms (1)

Cohort

EXPERIMENTAL

Drug: Elesclomol Sodium; Drug: Docetaxel

Interventions

Elesclomol Sodium DRUG

Chemotherapy agent

Cohort

Docetaxel DRUG

Chemotherapy agent

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (5)

Pacific Coast Hematology/Oncology Medical Group

Fountain Valley, California, 92708, United States

Location

Mayo Clinic

Rochester, Maryland, 55905, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (5)