CABozantinib in Non-Small Cell Lung Cancer (NSCLC) Patients With MET Deregulation
NCT ID: NCT03911193
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2018-09-21
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cabozantinib
Elegible NSCLC patients with MET exon 14 skipping mutations or MET amplification will be treated with open label orally cabozantinib 60 mg/daily, cycles each 28 days.
Cabozantinib
Patients will be treated with cabozantinib 60 mg/daily (cycles each 28 days) until progression, toxicity or patient refusal.
Interventions
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Cabozantinib
Patients will be treated with cabozantinib 60 mg/daily (cycles each 28 days) until progression, toxicity or patient refusal.
Eligibility Criteria
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Inclusion Criteria
2. Tissue samples available for MET analysis (archivial tissue or tissue collected at study entry); patients without archival tumor tissue or refusing new biopsy at study entry, are eligible if MET mutation is detected in cf-DNA
3. Presence of MET mutations (exon 14 skipping mutation ONLY) detected in tissue or cf-DNA at the local lab or in the central lab or MET amplification (MET/CEP7 ratio \> 2.2) detected in the central lab ONLY.
4. Measurable disease according to RECIST criteria version 1.1
5. At least 1 prior line of standard therapy (chemotherapy and/ or immunotherapy)
6. Performance status 0-1 (ECOG)
7. Age ≥18 years
8. Patients potentially fertile using adequate methods of contraception in order to avoid childbearing. Contraceptive methods must be respected by male and female patients and their partners during study treatment period and at least 4 months after completing therapy
9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment:
1. ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support
2. Platelet count ≥ 100,000/μL without transfusion
3. Hemoglobin ≥ 9.0 g/dL Patients may be transfused to meet this criterion
4. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions:
* Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN
* Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN.
5. Serum bilirubin ≤ 1.25 × ULN
6. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled
7. Calculated creatinine clearance (CRCL) ≥ 45 mL/min or calculated CRCL must be ≥ 60 mL/min
10. Patient compliance to the study procedure
11. Written informed consent
Exclusion Criteria
2. No possibility to assess MET status
3. Absence of any measurable disease according to RECIST criteria
4. Co-existence of driver events, including EGFR mutations, KRAS mutations, ALK rearrangements or ROS-1 rearrangements
5. No prior therapy
6. Concomitant chemotherapy or immunotherapy or radiotherapy
7. Symptomatic brain metastasis
8. Uncontrolled significant inter-current or recent illness, including cardio-vascular disorders and gastro-intestinal disorders
9. Major surgery within 2 months before first dose of study treatment
10. Concomitant anti-coagulation with oral anti-coagulants or plated inhibitors
11. History of significant bleeding, trachea-bronchial tree/major blood vessels invading tumors, cavity pulmonary lesions and GI disorders associated with a risk of perforation or fistula formation
12. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basalioid)
13. Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Fondazione Ricerca Traslazionale
OTHER
Responsible Party
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Principal Investigators
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Federico Cappuzzo
Role: PRINCIPAL_INVESTIGATOR
AUSL Romagna- P.O. di Ravenna
Locations
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A.O. "S.Giuseppe Moscati"
Avellino, AV, Italy
IRCCS Oncologico Giovanni Paolo II
Bari, BA, Italy
A.O.U. Careggi
Florence, FI, Italy
Irccs Irst
Meldola, FO, Italy
Ospedale Infermi Rimini
Rimini, FO, Italy
A.O. Papardo
Messina, ME, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Ospedale San Gerardo
Monza, MI, Italy
AOU Policlinico di Modena
Modena, MO, Italy
Casa di Cura La Maddalena
Palermo, PA, Italy
Istituto Oncologico Veneto
Padua, PD, Italy
A.O. S.M. Misericordia
Perugia, PG, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy
Azienda Ospedaliero- Universitaria di Parma
Parma, PR, Italy
AUSL Reggio Emilia- IRCCS Arcispedale S.M. Nuova
Reggio Emilia, RE, Italy
Fondazione Policlinico Gemelli
Roma, RM, Italy
Istituto Nazionale Tumori Regina Elena
Roma, RO, Italy
A.O.U. S. Luigi Gonzaga
Orbassano, Torino, Italy
AUSL della Romagna
Ravenna, , Italy
Azienda Ospedaliero Universitaria Integrata di Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CABinMET
Identifier Type: -
Identifier Source: org_study_id
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