Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
NCT ID: NCT03116971
Last Updated: 2020-09-16
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2017-05-25
2018-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
NCT01450761
Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
NCT00043927
Cisplatin Plus Etoposide With or Without Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT00003299
Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
NCT00321815
S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
NCT00045162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
M3814 PiC with Etoposide and Cisplatin
Participants received M3814 100 milligram (mg) powder in capsule (PiC) orally once daily in combination with Etoposide 100 mg/m\^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 milligram per square meter (mg/m\^2) over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until progressive disease (PD).
Cisplatin
Cisplatin 75 milligram per square meter (mg/m\^2) was administered over a 60-minute intravenous infusion on Day 1.
M3814
Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
Etoposide
Etoposide 100 mg/m\^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).
M3814 (HME Tablet + PiC) with Etoposide and Cisplatin
Participants received M3814 100 mg hot melt extrusion (HME) tablet orally 5 days prior to Day 1 and M3814 100 mg PiC, orally once daily from Day 1 in combination with Etoposide 100 mg/m\^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 mg/m\^2 over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until PD.
Cisplatin
Cisplatin 75 milligram per square meter (mg/m\^2) was administered over a 60-minute intravenous infusion on Day 1.
M3814
Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
Etoposide
Etoposide 100 mg/m\^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cisplatin
Cisplatin 75 milligram per square meter (mg/m\^2) was administered over a 60-minute intravenous infusion on Day 1.
M3814
Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
Etoposide
Etoposide 100 mg/m\^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research site
Mesa, Arizona, United States
Research site 1
Santa Rosa, California, United States
Research site
Santa Rosa, California, United States
Research site
Whittier, California, United States
Research site
Danbury, Connecticut, United States
Research site
Norwalk, Connecticut, United States
Research site
Columbus, Georgia, United States
Research site
Newnan, Georgia, United States
Research site
Topeka, Kansas, United States
Research site
Ashland, Kentucky, United States
Research site
Billings, Montana, United States
Research site
Pinehurst, North Carolina, United States
Research site
Cincinnati, Ohio, United States
Research site
Portland, Oregon, United States
Research site
Philadelphia, Pennsylvania, United States
Research site
Houston, Texas, United States
Research site
Aalst, , Belgium
Research site
Charleroi, , Belgium
Research site
Edegem, , Belgium
Research site
Ghent, , Belgium
Research site
Libramont, , Belgium
Research site
Liège, , Belgium
Research site
Roeselare, , Belgium
Research site
Yvoir, , Belgium
Research site 4
Sofia, , Bulgaria
Research site 2
Sofia, , Bulgaria
Research site 6
Sofia, , Bulgaria
Reasearch site 5
Sofia, , Bulgaria
Research site 3
Sofia, , Bulgaria
Research site 1
Sofia, , Bulgaria
Research site
Calgary, Alberta, Canada
Research site
Saint John, New Brunswick, Canada
Research site
London, Ontario, Canada
Research site
Toronto, Ontario, Canada
Research site
Benešov, , Czechia
Research site
Olomouc, , Czechia
Research site
Aalborg, , Denmark
Research site
Herlev, , Denmark
Research site
Odense C, , Denmark
Research site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Research site
Gauting, Bavaria, Germany
Research site
Nuremberg, Bavaria, Germany
Research site
Hanover, Lower Saxony, Germany
Research site
Chemnitz, Saxony, Germany
Research site
Kiel, Schleswig-Holstein, Germany
Research site
Lübeck, Schleswig-Holstein, Germany
Research site 1
Berlin, , Germany
Research site 2
Berlin, , Germany
Research site 1
Budapest, , Hungary
Research site 2
Budapest, , Hungary
Research site 3
Budapest, , Hungary
Research site
Farkasgyepű, , Hungary
Research site
Szekszárd, , Hungary
Research site
Szolnok, , Hungary
Research site
Rozzano, Milano, Italy
Research site
Catania, , Italy
Research site
Genova, , Italy
Research site
Napoli, , Italy
Research site
Ravenna, , Italy
Research site
Reggio Emilia, , Italy
Research site
Roma, , Italy
Research site
Torino, , Italy
Research site
Olsztyn, , Poland
Research site
Poznan, , Poland
Research site
Warsaw, , Poland
Research site
Wodzisław Śląski, , Poland
Research site
Baia Mare, , Romania
Research site
Cluj-Napoca, , Romania
Research site
Cluj-Napoca, , Romania
Research site
Craiova, , Romania
Research site
Timișoara, , Romania
Research site
Badajoz, , Spain
Research site 1
Madrid, , Spain
Research site 4
Madrid, , Spain
Research site 3
Madrid, , Spain
Research site 2
Madrid, , Spain
Research site
Hull, East Riding Of Yorkshire, United Kingdom
Research site
London, Greater London, United Kingdom
Research site
Sheffield, South Yorkshire, United Kingdom
Research site
Glasgow, Strathclyde, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MS100036-0022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.