Open-label, multicentre, phase IB/II study of MEN1611, a PI3K inhibitor, and cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens - MEN1611-02 (C-PRECISE)

Studio Clinico

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

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-003727-38

Data di inserimento: 20.10.2020

Data di aggiornamento: 04.02.2022

Promotore

Menarini

CRO

IQVIA

Principal Investigator ITALIA

IEO - Istituto Europeo di Oncologia

Riferimento: Prof. Giuseppe Curigliano

Telefono: 0257489599

Email: giuseppe.curigliano@ieo.it

Localita: Milano