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CLXH254X2102: A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma - NCT02974725

Studio Clinico

Patologia: Neoplasie del polmone, Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- ≤ 18 years
- Patients must have advanced or metastatic NSCLC or melanoma
- Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (melanoma) in tumor tissue
- All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Criteri di esclusione: 

Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. (Patients with KRAS mutant NSCLC with prior G12C inhibitor treatments are also excluded in the LXH254+trametinib expansion part). BRAF mutant patients group: Prior treatment with any EGFR, ALK, ROS1, KRAS, RAF (both BRAFV600 selective and pan-RAF), MEK1/2 and/or ERK1/2 inhibitors (for patients with BRAF V600 mutant NSCLC, prior treatments with BRAF and MEK1/2 inhibitors are allowed).
Patients who have received more than 3 lines of anti-cancer therapy are excluded.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
- Patients with Gilbert's syndrome or other heritable diseases of bile processing.
Other protocol-defined inclusion/exclusion criteria may apply

Trattamento sperimentale: 

- LXH254+LTT462
- LXH254+Trametinib
- LXH254+Ribociclib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [ Time Frame: up to 5 years ]
- Dose limiting toxicities (DLTs) (dose escalation only) [ Time Frame: up to 3 years ]
- Tolerability measured by the number of subjects who have interruptions/reductions of study treatment and reason for interruptions/reductions [ Time Frame: up to 5 years ]
- Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intentity [ Time Frame: Up to 5 years

Obiettivi secondari dello studio: 

- Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]
- Duration of response (DOR) [ Time Frame: Up to 5 years ]
- Disease Control Rate (DCR) [ Time Frame: Up to 5 years ]
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
- Overall Survival (OS) - (dose expansion part only) [ Time Frame: Up to 6 years ]
- Derived PK parameter (Cmax) for LXH254 & LTT462: [ Time Frame: Up to 5 years ]
- Derived PK parameter (AUC) for LXH254 & LTT462 [ Time Frame: Up to 5 years ]
- Changes from baseline of pharmacodynamics (PD) marker DUSP6 in tumor samples [ Time Frame: up to 5 years ]
- Derived PK parameter (Cmax) for LXH254 & trametinib [ Time Frame: up to 5 years ]
- Derived PK parameter (AUC) for LXH254 & trametinib [ Time Frame: Up to 5 years ]
- Derived PK parameter (Cmax) for LXH254 & ribociclib [ Time Frame: Up to 5 years ]
- Derived PK parameter (AUC) for LXH254 & ribociclib [ Time Frame: Up to 5 years ]

Note generali: 

Oltre al centro sotto riportato, allo studio partecipano diverse altre strutture ubicate nelle seguenti città:
- Milano (CAP 20133)
- Milano (CAP 20162)
- Verona (CAP 37126)
- Napoli (CAP 80131)

Centri partecipanti

Nord Italia

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282246280
Email: armando.santoro@cancercenter.humanitas.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-004293-18

Data di inserimento: 22.03.2021

Promotore

Novartis Pharmaceuticals

CRO

/

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano

Riferimento: Prof. Armando Santoro

Telefono: 0282246280

Email: armando.santoro@cancercenter.humanitas.it

Localita: Rozzano (MI)

 

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