Lung Cancer Clinical Trial
Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
Summary
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
Full Description
The study was intended to be a phase I/II trial, but the study never moved forward to Phase II due to recruitment challenges.
Eligibility Criteria
Inclusion Criteria:
To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria:
Male or female participants at least 18 years of age
Histological or cytological diagnosis of SCLC
Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator])
Participants eligible for first line platinum-based chemotherapy
Measurable or evaluable disease according to RECIST v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to (<=) 2
Life expectancy of greater than equals to (≥) 3 months
Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy Note: Other protocol defined criteria could apply.
Exclusion Criteria:
Participants are not eligible for the study if they fulfill any of the following exclusion criteria:
Prior anticancer therapy for extensive disease (ED) SCLC including experimental agents.
Concurrent use of other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug M3814.
Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by Investigator judgment)
Prior bone marrow/stem cell transplantation within 5 years before study start (Phase II only)
Major surgical intervention within 28 days prior to the first dose of investigational drug administration. Intervention(s) to establish the diagnosis for SCLC is permitted within 28 days as long as participants are cleared by the medical and surgical teams.
Poor vital organ functions defined as:
Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deci liter (g/dL) (5.7 micromole per liter (μmol/L)), absolute neutrophil count < 1.5 × 109/L, platelets < 100 × 109/L
Renal impairment as evidenced by calculated creatinine clearance < 60 mL/minutes (min) (according to the Cockcroft-Gault formula)
Liver function abnormality as defined by total bilirubin greater than (>) 1.5 × upper limit of normal (ULN) or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × ULN (participants with liver involvement: a maximum of AST/ALT 5 × ULN)
Contraindication to the use of etoposide or cisplatin
Participants currently receiving (or unable to stop using prior to receiving the first dose of investigational drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP) 3A and CYP2C19 (unless treatment can be discontinued at least 1 week prior to receiving the first dose of investigational drug) or potent inducers of CYP3A and CYP2C19 (unless treatment can be discontinued at least 3 weeks prior to receiving the first dose of investigational drug). Note: Other protocol defined criteria could apply.
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There are 76 Locations for this study
Mesa Arizona, 85206, United States
Santa Rosa California, 95403, United States
Santa Rosa California, 95403, United States
Whittier California, 90603, United States
Danbury Connecticut, 06810, United States
Norwalk Connecticut, 06850, United States
Columbus Georgia, 31904, United States
Newnan Georgia, 30265, United States
Topeka Kansas, 66606, United States
Ashland Kentucky, 41101, United States
Billings Montana, 59101, United States
Pinehurst North Carolina, 28374, United States
Cincinnati Ohio, 45229, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19124, United States
Houston Texas, 77030, United States
Aalst , 9300, Belgium
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Libramont , 6800, Belgium
Liège , 4000, Belgium
Roeselare , 8800, Belgium
Yvoir , 5530, Belgium
Sofia , 1330, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1632, Bulgaria
Sofia , 1784, Bulgaria
Calgary Alberta, T2N 4, Canada
St. John New Brunswick, E2L 4, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 2, Canada
Benesov , 256 0, Czechia
Olomouc , 775 2, Czechia
Aalborg , 9100, Denmark
Herlev , 2730, Denmark
Odense C , 5000, Denmark
Freiburg Baden Wuerttemberg, 79106, Germany
Gauting Bavaria, 82131, Germany
Nuernberg Bavaria, 90419, Germany
Hannover Lower Saxony, 30625, Germany
Chemnitz Saxony, 9113, Germany
Kiel Schleswig-Holstein, 24105, Germany
Luebeck Schleswig-Holstein, 23538, Germany
Berlin , 10117, Germany
Berlin , 10967, Germany
Budapest , 1121, Hungary
Budapest , 1121, Hungary
Budapest , 1125, Hungary
Farkasgyepu , 8582, Hungary
Szekszard , 7100, Hungary
Szolnok , 5000, Hungary
Rozzano Milano, 20089, Italy
Catania , 95123, Italy
Genova , 16132, Italy
Napoli , 80131, Italy
Ravenna , 48121, Italy
Reggio Emilia , 42100, Italy
Roma , 168, Italy
Torino , 10126, Italy
Olsztyn , 10-35, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Wodzislaw Slaski , 44-30, Poland
Baia Mare , 43029, Romania
Cluj-Napoca , 40001, Romania
Cluj-Napoca , 40005, Romania
Craiova , 20034, Romania
Timisoara , 30021, Romania
Badajoz , 6080, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Hull East Riding Of Yorkshire, HU16 , United Kingdom
London Greater London, W1G 6, United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
Glasgow Strathclyde, G12 O, United Kingdom
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