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Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

Sponsor
EMD Serono Research & Development Institute, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03116971
Collaborator
Merck KGaA, Darmstadt, Germany (Industry)
2
Enrollment
80
Locations
2
Arms
9.2
Actual Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter Study With an Open Label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and PK of M3814 in Combination With Etoposide and Cisplatin in Subjects With Treatment-naïve Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
Actual Study Start Date :
May 25, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: 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).
Other Names:
  • MSC2490484A
  • Peposertib

    • Drug: Cisplatin
    Cisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1.

    Drug: 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).
    Experimental: 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.

    Drug: 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).
    Other Names:
  • MSC2490484A
  • Peposertib

    • Drug: Cisplatin
    Cisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1.

    Drug: 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).

    Outcome Measures

    Primary Outcome Measures

    1. Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. [up to 21 days]

    2. Phase Ib: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of M3814 in Combination With Cisplatin and Etoposide for the Phase II Part of the Study [up to 11 months]

    3. Phase II: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1 [Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 24 months]

      PFS time will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause.

    Secondary Outcome Measures

    1. Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

      An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.

    2. Phase Ib: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs) [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

      Subjects will be analyzed for vital signs (eg, body temperature, respiratory rate, heart rate, and blood pressure), laboratory parameters and 12-lead ECG recorded at baseline and after administration of M3814. Number of subjects with abnormal values for laboratory values, vital signs and electrocardiograms (ECGs) will be reported.

    3. Phase Ib: Change in Eastern Cooperative Oncology Group performance status (ECOG PS) [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

    4. Phase Ib: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1 [Post randomization with period tumor evaluations until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy, assessed up to 11 months]

      The Objective Response Rate (ORR) is defined as the percentage of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the Investigator.

    5. Phase Ib: Duration of Response (DoR) According to RECIST v1.1 [First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months]

      The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator.

    6. Phase Ib: Percentage of Subjects With Disease Control [First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months]

      Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported.

    7. Phase Ib: Progression Free Survival (PFS) According to RECIST v1.1 [Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 11 months]

      The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. The PFS will be derived according to RECIST v1.1 as assessed by the Investigator.

    8. Phase Ib: Overall Survival (OS) [Time from randomization to death due to any cause, assessed up to 11 months]

      The OS time is defined as the date from randomization to death due to any cause.

    9. Phase Ib: Area under the concentration-time curve from 0 to 4 hours (AUC 0-4), 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide [Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose, C3D1 Pre-dose and 3.5 hrs post dose]

    10. Phase Ib: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide [Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    11. Phase Ib: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose]

    12. Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose]

    13. Phase Ib: Apparent Terminal Half-life (t1/2) for M3814 [C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose]

    14. Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814 [C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose]

    15. Phase Ib: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814 [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose]

    16. Phase Ib: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hr post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    17. Phase Ib: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814 [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    18. Phase Ib: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    19. Phase Ib: Terminal rate constant (λz) for M3814, Cisplatin and Etoposide [Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    20. Phase Ib: Changes in Cmax for M3814 Between Day -1 and C2D1 [Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    21. Phase Ib: Changes in AUC for M3814 Between Day -1 and C2D1 [Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    22. Phase Ib: Changes in AUC for Etoposide From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels) [Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    23. Phase Ib: Changes in Cmax for Etoposide From C1D1 and C2D1 [Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    24. Phase Ib: Changes in AUC for Cisplatin From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels) [Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    25. Phase Ib: Changes in Cmax for Cisplatin From C1D1 and C2D1 [Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose]

    26. Phase II: Overall Survival (OS) [Time from randomization to death due to any cause, assessed up to 24 months]

    27. Phase II: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1 [Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months]

      The Objective Response Rate (ORR) is defined as the proportion of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) Version 1.1 as assessed by the Investigator.

    28. Phase II: Duration of Response (DoR) According to RECIST v1.1 [First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months]

      The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator.

    29. Phase II: Percentage of Subjects With Disease Control [First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months]

      Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported.

    30. Phase II: Percentage of Subjects Who Received Prophylactic Cranial Irradiation (PCI) and/or Thorax Irradiation After 6 Cycles of Treatment [After 6 Cycles of treatment, assessed up to 24 months]

    31. Phase II: Tumor shrinkage From Baseline in target lesions [Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months]

    32. Phase II: Number of subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

      An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.

    33. Phase II: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs) [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

    34. Phase II: Change in Eastern Cooperative Oncology Group performance status (ECOG PS) [From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment]

    35. Phase II: Primary Health-Related Quality of Life (HRQoL) Based on Time to Definitive Deterioration (TUDD) as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months]

    36. Phase II: Primary HRQoL based on TUDD Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) [Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months]

    37. Phase II: Primary HRQoL based on TUDD Assessed Using European Quality of Life 5- dimensions questionnaire (EQ-5D) [Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months]

    38. Phase II: Area under the concentration-time curve from 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    39. Phase II: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    40. Phase II: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    41. Phase II: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    42. Phase II: Apparent Terminal Half-life (t1/2) for M3814 [C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose]

    43. Phase II: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814 [C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose]

    44. Phase II: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814 [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    45. Phase II: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide [Time Frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    46. Phase II: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814 [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    47. Phase II: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide [C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research site Mesa Arizona United States 85206
    2 Research site 1 Santa Rosa California United States 95403
    3 Research site Santa Rosa California United States 95403
    4 Research site Whittier California United States 90603
    5 Research site Danbury Connecticut United States 06810
    6 Research site Norwalk Connecticut United States 06850
    7 Research site Columbus Georgia United States 31904
    8 Research site Newnan Georgia United States 30265
    9 Research site Topeka Kansas United States 66606
    10 Research site Ashland Kentucky United States 41101
    11 Research site Billings Montana United States 59101
    12 Research site Pinehurst North Carolina United States 28374
    13 Research site Cincinnati Ohio United States 45229
    14 Research site Portland Oregon United States 97213
    15 Research site Philadelphia Pennsylvania United States 19124
    16 Research site Houston Texas United States 77030
    17 Research site Aalst Belgium 9300
    18 Research site Charleroi Belgium 6000
    19 Research site Edegem Belgium 2650
    20 Research site Gent Belgium 9000
    21 Research site Libramont Belgium 6800
    22 Research site Liège Belgium 4000
    23 Research site Roeselare Belgium 8800
    24 Research site Yvoir Belgium 5530
    25 Research site 4 Sofia Bulgaria 1330
    26 Research site 2 Sofia Bulgaria 1407
    27 Research site 6 Sofia Bulgaria 1431
    28 Reasearch site 5 Sofia Bulgaria 1527
    29 Research site 3 Sofia Bulgaria 1632
    30 Research site 1 Sofia Bulgaria 1784
    31 Research site Calgary Alberta Canada T2N 4N2
    32 Research site St. John New Brunswick Canada E2L 4L2
    33 Research site London Ontario Canada N6A 5W9
    34 Research site Toronto Ontario Canada M5G 2M9
    35 Research site Benesov Czechia 256 01
    36 Research site Olomouc Czechia 775 20
    37 Research site Aalborg Denmark 9100
    38 Research site Herlev Denmark 2730
    39 Research site Odense C Denmark 5000
    40 Research site Freiburg Baden Wuerttemberg Germany 79106
    41 Research site Gauting Bavaria Germany 82131
    42 Research site Nuernberg Bavaria Germany 90419
    43 Research site Hannover Lower Saxony Germany 30625
    44 Research site Chemnitz Saxony Germany 9113
    45 Research site Kiel Schleswig-Holstein Germany 24105
    46 Research site Luebeck Schleswig-Holstein Germany 23538
    47 Research site 1 Berlin Germany 10117
    48 Research site 2 Berlin Germany 10967
    49 Research site 1 Budapest Hungary 1121
    50 Research site 2 Budapest Hungary 1121
    51 Research site 3 Budapest Hungary 1125
    52 Research site Farkasgyepu Hungary 8582
    53 Research site Szekszard Hungary 7100
    54 Research site Szolnok Hungary 5000
    55 Research site Rozzano Milano Italy 20089
    56 Research site Catania Italy 95123
    57 Research site Genova Italy 16132
    58 Research site Napoli Italy 80131
    59 Research site Ravenna Italy 48121
    60 Research site Reggio Emilia Italy 42100
    61 Research site Roma Italy 168
    62 Research site Torino Italy 10126
    63 Research site Olsztyn Poland 10-357
    64 Research site Poznan Poland 60-569
    65 Research site Warszawa Poland 02-781
    66 Research site Wodzislaw Slaski Poland 44-300
    67 Research site Baia Mare Romania 430291
    68 Research site Cluj-Napoca Romania 400015
    69 Research site Cluj-Napoca Romania 400058
    70 Research site Craiova Romania 200347
    71 Research site Timisoara Romania 300210
    72 Research site Badajoz Spain 6080
    73 Research site 1 Madrid Spain 28040
    74 Research site 4 Madrid Spain 28040
    75 Research site 3 Madrid Spain 28046
    76 Research site 2 Madrid Spain 28050
    77 Research site Hull East Riding Of Yorkshire United Kingdom HU16 5JQ
    78 Research site London Greater London United Kingdom W1G 6AD
    79 Research site Sheffield South Yorkshire United Kingdom S10 2SJ
    80 Research site Glasgow Strathclyde United Kingdom G12 OYN

    Sponsors and Collaborators

    • EMD Serono Research & Development Institute, Inc.
    • Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMD Serono Research & Development Institute, Inc.
    ClinicalTrials.gov Identifier:
    NCT03116971
    Other Study ID Numbers:
    • MS100036-0022
    First Posted:
    Apr 17, 2017
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by EMD Serono Research & Development Institute, Inc.
    M3814, Small Cell Lung Cancer (SCLC), Deoxyribonucleic acid-dependent protein kinase inhibitor, Chemotherapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Etoposide
    Peposertib

    Study Results

    No Results Posted as of Sep 16, 2020