Study to assess the efficacy of budesonide in preventing diarrhea caused by treatment with cabazitaxel (CABARESC)

Phase 1

• Conditions: metastatic prostate cancer; MedDRA version: 18.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003346-40-NL
• Lead Sponsor: Erasmus MC-Daniël den Hoed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-08
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Metastatic castrate resistant prostate cancer (mCRPC) patients with documented disease progression
-If measureable disease: documented disease progression as defined in RECIST criteria v 1.1
-If non-measurable disease: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesions
•Previous treatment with a docetaxel-containing regimen
•Age ? 18 years;
•WHO performance status ? 1 (see appendix B);
•Adequate renal and hepatic functions defined as (serum creatinin <150µmol/l (<1.7mg/dl), total bilirubin < 1.0 xULN; alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) <1.5x ULN, in case of liver metastasis < 5 ULN; alkaline phosphatase (AF) < 5x ULN) In case of bone metastasis, AF < 10x ULN is accepted;
•Adequate hematological blood counts defined as (absolute neutrophil count (ANC) > 1.5 x 109/L and platelets > 100 x 109/L);
•Castration, either surgically or by continued LHRH agonist therapy
•Written informed consent according to ICH-GCP

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

•Impossibility or unwillingness to take oral drugs;
•Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
•Use of medications or dietary supplements known to induce or inhibit CYP3A (see section 5.11)
•Use of hormonal agents other than Gn-RH agonists
•Chemotherapy within the last 4 weeks before randomization
•Radiotherapy within the last 4 weeks before randomization
•Known hypersensitiveness to corticosteroids
•Systemic or local bacterial, viral, fungal - or yeast infection.
•Hepatic impairment (Child-Pugh score B-C)
•Portal hypertension (grade 1-4 CTC-NCI criteria)
•Ulcerative colitis, Crohn’s disease or celiac disease
•Simultaneous yellow fever vaccine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified