Stage II with advanced Castration-Resistant Prostate Cancer (CRPC)
Conditions
Interventions
Trade Name: Jevtana®
Product Name: Jevtana®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cabazitaxel acetone solvate
CAS Number: 183133-96-2
Current Sponsor code: RP
Sponsors
CESAR Central European Society for Anticancer Drug Research - EWIV
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Capable of understanding the protocol requirements and risks, and providing written informed consent. (2)Patients with histologically or cytologically proven, castration-resistant prostate adenocarcinoma, that progressed during or after completion of previous docetaxel treatment. (3)Patients with a formal indication for monotherapy with IV cabazitaxel at 3-weekly cycles. (4)Measurable or non-measurable (evaluable) disease according to the RECIST criteria, version 1.1. (5)ECOG Performance Status (ECOG-PS) status 0-2. (6)Male patients at least 18 years of age at randomization. (7)Patients have received prior castration by orchiectomy and/or a Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist with or without antiandrogens, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents (antiandrogen treatment is continued during study treatment). (8)Patients may also having received prior abiraterone acetate, TAK700 or enzalutamide. (9)Sexually active men must use acceptable contraceptive methods (condom). (10)Patients suffering from asymptomatic brain metastases can be enrolled in case corticosteroid therapy is not indicated. Prior irradiation must be completed at least 2 week prior to initiating cabazitaxel chemotherapy within the study. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: (1)Previous treatment with cabazitaxel. (2)Prior isotope therapy or radiotherapy to =30% of the bone marrow. (3)Adverse events grade >1 (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy at the time of randomization. (4)Prior malignancy. Adequately treated basal-cell or squamous-cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed = 5 years ago and from which the patient has been disease-free for = 5 years. (5)Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. (6)Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (7)Inadequate organ and bone marrow function as evidenced by: a.Hemoglobin 1.5•ULN (>5•ULN in case of liver metastases) e.Total bilirubin >1.0•ULN (>2.5•ULN in case of liver metastases) f.Serum creatinine >1.5•ULN. If creatinine 1.0-1.5xULN, creatinine clearance will be calculated according to the CKD-EPI formula and patients with creatinine clearance 2 (13)Treatment with cytotoxic or biologic agents or any experimental drug within the 2 weeks prior to beginning treatment on this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the CAINTA study is to apply individualized cabazitaxel dosing in patients with advanced CRPC. By applying the prespecified dosing algorithm in the experimental treatment group (Arm B), the clinical feasibility rate is expected to increase from 40% in the conventional treatment Arm A to 75% in the experimental treatment Arm B (all toxicity grading according to the CTCAE version 4.0). Clinical feasibility is defined as the absence of any of the following criteria: Grade 4 neutropenia, grade 4 thrombocytopenia, thrombocytopenia of any grade with bleeding, febrile neutropenia, grade 3-4 non-hematological toxicity, withdrawal due to cabazitaxel-related toxicity or death. At the same time, progression-free survival (PFS) and overall survival (OS) must not be affected by individualized dosing of cabazitaxel.;Secondary Objective: •PSA-response in patients with a baseline PSA-value of 20 µg/L, defined as a 50% decline of PSA and best PSA Response •Time to PSA-progression, defined as an increase of PSA by = 25% from the nadir and an absolute increase of = 5 ng/mL from the nadir •Tumor response acc. to the RECIST v.1.1 •All AEs will be ass. acc. to the NCI CTCAE v.4.0 crit.until 30 days after study treatment with cabazitaxel ended •The rate of severe (grade 3 and 4, acco. to the RECIST v.1.1 crit.) neutropenia until 30 days after study treat. with cabazitaxel ended •Progression-free survival (PFS), defined as follows: Time from registration until one of the following events (whichever occurs first): -Progression assessment acco. to the RECIST criteria -Death of any cause •Overall survival (OS) and survival rate after 6,12 and 18 months •Area-under-the concentration-time curve (AUC) of cabazitaxel from the final population pharmac. model •Quality-of-life according to the EORTC QLQ-C30 questionnaire ;Primary end point(s): The primary endpoint of the present protocol is the clinical feasibility rate, defined as the absence of any of the | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •PSA-response in patients with a baseline PSA-value of =20 µg/L [14], defined as a =50% decline of PSA and best PSA response •Time to PSA-progression, defined as an increase of PSA by = 25% from the nadir and an absolute increase of = 5 ng/mL from the nadir •Tumor response according to the RECIST v.1.1 criteria •All AEs will be assessed according to the NCI CTCAE v.4.0 criteria until 30 days after study treatment with cabazitaxel ended •The rate of severe (grade 3 and 4, according to the RECIST v.1.1 criteria) neutropenia until 30 days after study treatment with cabazitaxel ended •Progression-free survival (PFS), defined as follows: Time from registration until one of the following events (whichever occurs first): -Progression assessed according to the RECIST criteria -Death of any cause •Overall survival (OS) and survival rate after 6,12 and 18 months •Area-under-the concentration-time curve (AUC) of cabazitaxel from the final population pharmacokinetic model •Quality-of-life according to the EORTC QLQ-C30 questionnaire ;Timepoint(s) of evaluation of this end point: the occurance of one the above mentioned criteria | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactSponsor
CESAR Central European Society for Anticancer Drug Research - EWIV
Outcome results
None listed