metatastatic colorectal carcinoma MedDRA version: 21.0 Level: LLT Classification code 10001172 Term: Adenocarcinoma of colon stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: KADCYLA - 100 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO
Product Name: KADCYLA
Pharmaceutical Form: Powder for solution f
Sponsors
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological/confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery. 2. Progression (PD) after therapy with lapatinib plus trastuzumab combination within the HERACLES - A trial. 3. ECOG PS 2.5xUNL, alkaline phosphatase liver fraction must be ¿ 2.5xUNL 8. Adequate contraception for all fertile patients 9. Negative pregnancy test. Non mandatory pre-treatment biopsy is strongly encouraged. 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases 2. Active infection 3. Interval from last anti HER2 therapy 150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; chronic heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication, baseline Left Ventricular Ejection Fraction (LVEF) = 55% measured by echocardiography (ECHO) 6. Major surgery in the two weeks prior to entering the clinical trial 7. Concurrent treatment with any other anti-cancer therapy 8. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons 9. Pregnant and lactating women 10. Men and women of childbearing potential who are not using an effective method of contraception 11. Participation in another clinical trial 12. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Define the efficacy of trastuzumab-emtansine in HER2 amplified metastatic CRC patients with advanced disease refractory to chemotherapy, anti EGFR monoclonals, antiangiogenics and lapatinib plus trastuzumab combination (i.e. patients progressing within the HERACLES trial). ;Secondary Objective: Define the safety profile of T-DM1 in patients pre-treated with trastuzumab-lapatinib. Define the response duration to T-DM1 Define the time to progression to T-DM1;Primary end point(s): Objective Response Rate according to RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: first assessment after 6 weeks, then every 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Description of the frequency and severity of Adverse Events based on the NCI ¿CTCAE V4.0; DCR; TTP;Timepoint(s) of evaluation of this end point: thoughtout the study; thoughtout the study; thoughtout the study | — |
Countries
Italy
Contacts
Public ContactClinical Trial Coordination Unit
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed