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Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients

NCT01254279•Sanofi

View on ClinicalTrials.gov

Summary

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Metastatic Hormone Refractory Prostate Cancer (mHRPC) previously treated with a docetaxel-containing regimen
•Disease Progression during or after docetaxel-containing regimen for mHRPC
•Surgical or medical castration
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
•Life-expectancy ≥3 months
•Adequate bone marrow, liver, and renal function: Neutrophils\> 1500 /mm3; Hemoglobin \> 10 g/dL; Platelets \> 100 x109/L; Bilirubin \< ULN; SGOT (AST) \< 1.5xULN; SGPT (ALT) \< 1.5xULN; Creatinine \< 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \< 60 mL/min should be excluded.

Exclusion Criteria

•Prior radiotherapy to ≥ 40% of bone marrow
•Prior radionuclide therapy (samarium-153, strontium-89, P-32…)
•Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
•Active grade ≥2 peripheral neuropathy
•Active grade ≥2 stomatitis
•Active infection requiring systemic antibiotic or anti-fungal medication
•Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years (except superficial basal cell skin cancer)
•Known brain or leptomeningeal involvement
•History of severe hypersensitivity reaction (≥grade 3) to docetaxel
•History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
+6 more criteria

Locations (165)

Investigational Site Number 036004

Box Hill, Australia

Investigational Site Number 036020

Campbelltown, Australia

Investigational Site Number 036001

Camperdown, Australia

Investigational Site Number 036002

Camperdown, Australia

Investigational Site Number 036011

Douglas, Australia

Investigational Site Number 036019

Nambour, Australia

Investigational Site Number 036023

North Adelaide, Australia

Investigational Site Number 036008

Parkville, Australia

Investigational Site Number 036005

Perth, Australia

Investigational Site Number 036003

Port Macquarie, Australia

Key Dates

Start Date

December 1, 2010

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

January 21, 2015

Enrollment

984

ACTUAL participants

Conditions

Prostate Cancer Metastatic

Interventions

CABAZITAXEL

DRUG

PSMA PET for Surveillance After Focal Therapy

NCT07115914

Prostate Cancer (Adenocarcinoma)Prostate Cancer (Diagnosis)+1 more

View study

RECRUITINGNA

Exercise in Prostate Cancer

NCT06165302

Prostate Cancer MetastaticProstate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Inclusion Criteria

Exclusion Criteria

PSMA PET for Surveillance After Focal Therapy

Exercise in Prostate Cancer

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