Trial record 1 of 1 for:
NCT02357147
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) (ARTEMIS)
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| ClinicalTrials.gov Identifier: NCT02357147 |
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Recruitment Status :
Terminated
(Due to business reasons)
First Posted : February 6, 2015
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
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Sponsor:
Morphotek
Information provided by (Responsible Party):
Morphotek
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Mesothelioma, Malignant |
| Interventions |
Drug: Placebo Drug: Amatuximab Drug: Pemetrexed Drug: Cisplatin |
| Enrollment | 124 |
Participant Flow
| Recruitment Details | Participants took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018. |
| Pre-assignment Details | A total of 124 participants were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in participant flow excluding those that occurred after treatment discontinuation. |
| Arm/Group Title | Amatuximab + Pemetrexed + Cisplatin | Placebo + Pemetrexed + Cisplatin |
|---|---|---|
 Arm/Group Description |
During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression. | During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression. |
| Period Title: Combination Treatment Phase | ||
| Started | 52 | 56 |
| Treated | 52 | 54 |
| Completed | 26 | 29 |
| Not Completed | 26 | 27 |
| Reason Not Completed | ||
| Progressive Disease (Radiographic test) | 3 | 3 |
| Progressive Disease(Clinical assessment) | 0 | 1 |
| Investigator Discretion | 1 | 1 |
| Withdrawal by Subject | 4 | 2 |
| Test Article Held (Greater than 21 Days) | 4 | 1 |
| Adverse Event | 12 | 4 |
| Death | 1 | 1 |
| Sponsor Decision | 0 | 12 |
| Other | 1 | 0 |
| Not treated | 0 | 2 |
| Period Title: Maintenance Treatment Phase | ||
| Started | 26 | 29 |
| Treated | 25 | 29 |
| Completed | 0 | 0 |
| Not Completed | 26 | 29 |
| Reason Not Completed | ||
| Progressive Disease (Radiographic test) | 15 | 10 |
| Withdrawal by Subject | 0 | 1 |
| Test Article Held (Greater than 21 Days) | 10 | 0 |
| Adverse Event | 0 | 3 |
| Sponsor Decision | 0 | 15 |
| Not Treated | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Amatuximab + Pemetrexed + Cisplatin | Placebo + Pemetrexed + Cisplatin | Total | |
|---|---|---|---|---|
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Arm/Group Description |
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression. | During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 52 | 54 | 106 | |
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Baseline Analysis Population Description |
The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 52 participants | 54 participants | 106 participants | |
| 67.9 (6.08) | 66.9 (7.96) | 67.4 (7.08) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 52 participants | 54 participants | 106 participants | |
| Female |
15 28.8%
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14 25.9%
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29 27.4%
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| Male |
37 71.2%
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40 74.1%
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77 72.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 52 participants | 54 participants | 106 participants | |
| Hispanic or Latino |
1 1.9%
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7 13.0%
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8 7.5%
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| Not Hispanic or Latino |
42 80.8%
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37 68.5%
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79 74.5%
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| Unknown or Not Reported |
9 17.3%
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10 18.5%
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19 17.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 52 participants | 54 participants | 106 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 1.9%
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0 0.0%
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1 0.9%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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1 1.9%
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1 0.9%
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| White |
45 86.5%
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46 85.2%
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91 85.8%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
6 11.5%
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7 13.0%
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13 12.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
The study was terminated due to business decision. No safety concerns involved in decision to terminate this study.
More Information
Results Point of Contact
| Name/Title: | Eisai Medical Information |
| Organization: | Eisai Inc. |
| Phone: | 1-888-274-2378 |
| EMail: | esi_oncmedinfo@eisai.com |
| Responsible Party: | Morphotek |
| ClinicalTrials.gov Identifier: | NCT02357147 |
| Other Study ID Numbers: |
MORAb-009-201 2014-004489-85 ( EudraCT Number ) |
| First Submitted: | January 14, 2015 |
| First Posted: | February 6, 2015 |
| Results First Submitted: | March 4, 2020 |
| Results First Posted: | March 17, 2020 |
| Last Update Posted: | March 17, 2020 |