Multicenter, prospective, non-randomized, phase II trial designed to evaluate the activity of Cabazitaxel in patients with advanced Adreno-Cortical
- Conditions
- MedDRA version: 21.1Level: PTClassification code 10061588Term: Adrenal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Histologically confirmed diagnosis of ACCLocally advanced or metastatic disease not amenable to radical surgery resectionTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001591-35-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 25
•Histologically confirmed diagnosis of ACC
•Locally advanced or metastatic disease not amenable to radical surgery resection
•Radiologically monitorable disease
•Progressing disease after one to three cytotoxic chemotherapy regimes (including a platin-based protocol)
•ECOG performance status 0-2
•Life expectancy = 3 months
•Age = 18 years
•Adequate bone marrow reserve (neutrophils = 1500/mm³ and platelets > 100.000/mm³)
•Effective contraception in pre-menopausal female and male patients
•Patient´s written informed consent
•Ability to comply with the protocol procedures
•Mitotane intake should be stopped one months before the study entry
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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
•History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
•Serum creatinine > 1.5 x ULN, BCC <60 mL/min) or hepatic insufficiency (ALT / AST > 1.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN) Hemoglobin <10.0 g/dL;
•Total bilirubin >1x ULN,
•Creatinine < 1.5 ULN;
•Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
•Pregnancy or breast feeding
•Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
•Patients with serum levels of mitotane (evaluated one week before the study start) in the therapeutic range (14-20 mcg/ml).History of severe hypersensitivity reaction (=grade 3) to docetaxel
•History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
•Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
•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) (see Annex 1 and Annex 2)
•Concomitant vaccination with yellow fever vaccine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the clinical benefit as measured by a non progressing rate after 4 months of the cabazitaxel in patients with locally advanced or metastatic ACC who progressed after cytotoxic therapy.;Secondary Objective: •Assessment of Objective Response Rates (ORR), evaluated by RECIST criteria<br>•Assessment of hormone response<br>•Assessment of overall survival, defined as the time from the date of the study start to <br>date of death due to any cause<br>•Assessment of quality of life by EORTC QLQ-C30<br>•Assessment of toxicity, evaluated by NCI CTCAE V4.03 criteria.<br>;Primary end point(s): To assess the clinical benefit as measured by a non progressing rate after 4 months of the cabazitaxel in patients with locally advanced or metastatic ACC who progressed after cytotoxic therapy.;Timepoint(s) of evaluation of this end point: Day1<br>Cycle 2 until disease progression<br>(max 6 cycles)Discontinues from treatment<br>28 days after last dose)<br>Every 30 days for 6 months<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Assessment of Objective Response Rates (ORR), evaluated by RECIST criteria<br>•Assessment of hormone response<br>•Assessment of overall survival, defined as the time from the date of the study start to <br>date of death due to any cause<br>•Assessment of quality of life by EORTC QLQ-C30<br>•Assessment of toxicity, evaluated by NCI CTCAE V4.03 criteri<br>;Timepoint(s) of evaluation of this end point: Every 8 weeks for the first 4 months and every 12 weeks