Patologia: Tumori del colon retto
Osservazionale-Sperimentale: Sperimentale
Randomizzato: No
Fase di studio: 1, I B, II
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Terza/N linea
Criteri di inclusione:
- Histological documentation of adenocarcinoma of the colon or rectum.
- Progression or recurrence following irinotecan, oxaliplatin, fluoropyrimidine containing regimen and anti-EGFR containing regimens for metastatic disease.
- Best response according to Response Evaluation Criteria in Solid Tumours criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
- Measurable disease according to RECIST criteria.
- N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Criteri di esclusione:
- Previous treatment with PI3K inhibitor.
- Brain metastases, with the exception of patients with previously treated brain metastases (including radiation
and/or surgery) > 4 weeks before the Screening Visit and only if clinically stable, and not receiving corticosteroids.
- NCI CTCAE v5.0 Grade ≥ 2 diarrhoea.
- History of significant, uncontrolled or active cardiovascular disease.
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL.
- Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
- Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.
Trattamento sperimentale:
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Cetuximab once per week as intravenous infusion.
Trattamento di controllo:
NA
Obiettivi primari dello studio:
Step 1:
• To determine the RP2D of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
Step 2:
• To assess the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
Obiettivi secondari dello studio:
• To assess the safety and tolerability of MEN1611 in combination with cetuximab.
• To assess the pharmacokinetic (PK) profile of MEN1611 when given in combination with cetuximab.
Note generali:
Data fine arruolamento: luglio 2023
Data di inizio dell'arruolamento: 20.07.2020
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Riferimento: Prof. Alberto Sobrero
Telefono: 0105553301
Email: alberto.sobrero@hsanmartino.it
Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Riferimento: Prof. Salvatore Siena
Email: oncologia@ospedaleniguarda.it
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
Riferimento: Prof. Armando Santoro
Telefono: 0282244080
Email: armando.santoro@humanitas.it
AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Riferimento: Dr.ssa Chiara Cremolini
Telefono: 050992192
Email: chiaracremolini@gmail.com
Numero di iscrizione a registro: 2019-003727-38
Data di inserimento: 20.10.2020
Data di aggiornamento: 04.02.2022
Menarini
IQVIA
IEO - Istituto Europeo di Oncologia
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Localita: Milano