XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00417079

Purpose

This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

Condition	Intervention	Phase
Neoplasms Prostatic Neoplasms	Drug: XRP6258 (RPR116258) Drug: mitoxantrone Drug: prednisone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Open Label Multi-Center Study of XRP6258 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

overall survival defined as the time interval from the date of randomization to the date of death due to any cause. [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PSA levels [ Time Frame: at screening, day 1 of every treatment cycle, end of study treatment, and in follow-up until documented progression ] [ Designated as safety issue: No ]
Anti-tumor activity via Computerized Tomography / Magnetic Resonance Imaging (and bone scans, as indicated) [ Time Frame: study period ] [ Designated as safety issue: No ]
Pain via an analgesic consumption score and the Present Pain Index over a one-week period [ Time Frame: study period ] [ Designated as safety issue: No ]
Adverse events; laboratory abnormalities; vital signs [ Time Frame: Study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	720
Study Start Date:	December 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Active Comparator	Drug: mitoxantrone administered by IV route Drug: prednisone administered by oral route
Arm B: Experimental	Drug: XRP6258 (RPR116258) administered by IV route Drug: prednisone administered by oral route

Eligibility

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

Criteria

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate.
Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising PSA levels or appearance of new lesion.
Surgical or hormone-induced castration
Life expectancy > 2 months
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

Previous treatment with mitoxantrone
Prior radiotherapy to ≥ 40% of bone marrow
Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
Known brain or leptomeningeal involvement
Other concurrent serious illness or medical conditions
Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417079

Show 27 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6193
Study First Received:	December 28, 2006
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00417079 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada

Keywords provided by Sanofi-Aventis:

Cancer
Prostate

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
Hormones

Glucocorticoids
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Mitoxantrone
Analgesics
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010