Neuroendocrine Carcinomas MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TEMODAL - 5 MG CAPSULA RIGIDA 1 FLACONE 20 CAPSULE USO ORALE
Product Name: temodal
Product Code: temozolomide
Pharmaceutical Form: Capsule, hard
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient’s awareness and willingness to comply with the study requirements. - Patients =18 years of age. - Histologically confirmed Metastatic Neuroendocrine Carcinoma (Ki67>20% Ki67 must be quantified in percentage) with documented progression of disease per investigator assessment following or during first-line platinum-based treatment. - ECOG performance status (PS) of 0-2. - At least 28 days since prior radiation therapy or surgery and recovery from treatment. - Patients must have measurable disease which must be evaluable per RECIST v1.1. - Estimated life expectancy of =12 weeks. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Patients 1.5 except for patients on stable anticoagulant therapy b. aPTT =1.5 times ULN or greater than the lower limit of the therapeutic range Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1, Cycle 1. Serum chemistry: a. Total bilirubin >1.5 times ULN b. AST or ALT >2 times ULN (>5 times ULN for patients with known liver involvement) c. ALP >2 times ULN (>5 times ULN for patients with known liver involvement and >7 times ULN for patients with known bone involvement).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of Temozolomide for second-line treatment of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy;Secondary Objective: To assess the clinical benefit of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy;Primary end point(s): -Overall response rate (ORR);Timepoint(s) of evaluation of this end point: 9 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical Benefit Rate (CBR) - Second Line Progression Free Survival (PFS) - Overall survival (OS) - 1 Year OS - Safety and tolerability - Duration of response - Quality of Life (QoL) ;Timepoint(s) of evaluation of this end point: 9 WEEKS | — |
Countries
Italy
Contacts
Public ContactOncologia Medica Addominale
Istituto Tumori di Napoli
Outcome results
None listed