Trial · NCT00738582
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
NCT00738582, Phase 2, Completed, Morphotek; results first posted 2022-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma. Trials, record NCT00738582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
- NCT number
- NCT00738582
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Malignant Pleural Mesothelioma
- Interventions
- MORAb-009 (Amatuximab), Pemetrexed, Cisplatin
- First posted
- 2008-08-20
- Last updated
- 2022-09-22
- Other registries' IDs
- eudract:2008-005448-18
- Results first posted
- 2022-09-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 | Month 6 | Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions. |
| Secondary | Overall Response Rate (ORR) | From the date of first dose until evidence of CR or PR, up to approximately 5 years | ORR, defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR) as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. A confirmed response required a repeat observation on two occasions 4 weeks apart. ORR = CR + PR. |
| Secondary | Duration of Response (DR) | From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years | DR was derived for those participants who achieved a PFS Response and had an objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression or death \[as determined by independent radiologist based on the modified RECIST utilizing the total tumor measurement (performed by CT/ MRI) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement\]. Tumor assessments performed up to the initiation of further anticancer therapy were considered. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions. |
| Secondary | Time to Tumor Response (TTR) | From the date of the first dose to first documentation of objective response, up to approximately 5 years | TTR was derived for those participants with objective evidence of CR or PR. TTR was defined as the time from the date of the first dose of amatuximab to first documentation of objective tumor response. CR was defined as the disappearance of all target lesions with no evidence of tumor elsewhere, and PR was defined as at least a 30% reduction in the total tumor measurement. |
| Secondary | Overall Survival (OS) | From the date of first dose to the date of death, up to approximately 5 years | OS was defined as the time from the date of the first dose of amatuximab to the date of death. |
| Secondary | Overall Progression Free Survival | From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years | Overall PFS was defined as the time from the date of first dose of amatuximab to the date of disease progression or death due to any cause. In the absence of confirmation of death, the survival time was censored at the date of the last follow-up contact. Tumor assessments performed up to the initiation of further anticancer therapy were considered. PD as measured by Modified RECIST was defined as an increase of at least 20% in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions. |
| Other | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab | From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years | An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as an AE that developed or worsened in severity during the on-treatment period (from first dose of amatuximab to 30 days after last dose of amatuximab). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 | Month 6 | Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analyzed are first 77 enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | From the date of first dose until evidence of CR or PR, up to approximately 5 years | Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years | Primary Efficacy Population: all participants who received at least 1 dose of amatuximab, met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analysed included responders (CR or PR). | Months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | From the date of the first dose to first documentation of objective response, up to approximately 5 years | Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). Here, number of participants analysed included responders (CR or PR). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of first dose to the date of death, up to approximately 5 years | Safety population consisted of all participants who received at least 1 dose of amatuximab. | Months | MEDIAN |
| SECONDARY | Overall Progression Free Survival | From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years | Primary Efficacy Population: all participants who received at least 1 dose of amatuximab and met key eligibility criteria (had measurable disease at screening, had unresectable disease, and had at least 1 response assessment or died after starting treatment with amatuximab). | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab | From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years | Safety population included all participants who received at least 1 dose of amatuximab. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 | All Participants | PFS Responders | 26 | Participants | |
| Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 | All Participants | PFS non-responders | 51 | Participants | |
| Overall Response Rate (ORR) | All Participants | 34.5 | Percentage of participants | ||
| Duration of Response (DR) | All Participants | 9.2 | 95% Confidence Interval 6.0 to 16.2 | Months | |
| Time to Tumor Response (TTR) | All Participants | 2.3 | 95% Confidence Interval 2.1 to 3.8 | Months | |
| Overall Survival (OS) | All Participants | 14.8 | 95% Confidence Interval 12.4 to 18.8 | Months | |
| Overall Progression Free Survival | All Participants | 6.3 | 95% Confidence Interval 6.0 to 7.8 | Months | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab | Amatuximab/Pemetrexed/Cisplatin | Participants with at least 1 TEAE | 89 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab | Amatuximab | Participants with at least 1 TEAE | 52 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab | Amatuximab/Pemetrexed/Cisplatin | Participants with at least 1 SAE | 38 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Combination Therapy | STARTED | Amatuximab/Pemetrexed/Cisplatin | 89 | |
| Combination Therapy | STARTED | Amatuximab | 0 | |
| Combination Therapy | COMPLETED | Amatuximab/Pemetrexed/Cisplatin | 56 | |
| Combination Therapy | COMPLETED | Amatuximab | 0 | |
| Combination Therapy | NOT COMPLETED | Amatuximab/Pemetrexed/Cisplatin | 33 | |
| Combination Therapy | NOT COMPLETED | Amatuximab | 0 | |
| Maintenance Therapy | STARTED | Amatuximab/Pemetrexed/Cisplatin | 0 | |
| Maintenance Therapy | STARTED | Amatuximab | 56 | |
| Maintenance Therapy | COMPLETED | Amatuximab/Pemetrexed/Cisplatin | 0 | |
| Maintenance Therapy | COMPLETED | Amatuximab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events822
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain Lower | Gastrointestinal disorders | Amatuximab/Pemetrexed/Cisplatin | 1 | 89 | |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Amatuximab | 1 | 56 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | Amatuximab/Pemetrexed/Cisplatin | 1 | 89 | |
| other | Abdominal Tenderness | Gastrointestinal disorders | Amatuximab | 1 | 56 | |
| other | Anal Fissure | Gastrointestinal disorders | Amatuximab/Pemetrexed/Cisplatin | 1 | 89 | |
| other | Anal Fissure | Gastrointestinal disorders | Amatuximab | 0 | 56 | |
| other | Anorectal Discomfort | Gastrointestinal disorders | Amatuximab/Pemetrexed/Cisplatin | 1 | 89 | |
| other | Anorectal Discomfort | Gastrointestinal disorders | Amatuximab | 0 | 56 | |
| other | Bowel Movement Irregularity | Gastrointestinal disorders | Amatuximab/Pemetrexed/Cisplatin | 1 | 89 | |
| other | Bowel Movement Irregularity | Gastrointestinal disorders | Amatuximab | 0 | 56 |
1 to 10 of 822Source ClinicalTrials.gov
See all 822 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amatuximab/Pemetrexed/Cisplatin | 4 | 89 |
| Total, all-cause mortality | Amatuximab | 0 | 56 |
| Total, other adverse events | Amatuximab/Pemetrexed/Cisplatin | 89 | 89 |
| Total, other adverse events | Amatuximab | 52 | 56 |
| Total, serious adverse events | Amatuximab/Pemetrexed/Cisplatin | 38 | 89 |
| Total, serious adverse events | Amatuximab | 15 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amatuximab/Pemetrexed/Cisplatin vs Amatuximab: deaths from any cause | Trial comparisons |
| Amatuximab/Pemetrexed/Cisplatin vs Amatuximab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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The record and each of its lists are JSON, twenty rows a page. No key.
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