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NCT00738582 · REGISTRY CONDITION SEARCH

An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-09-22

This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Duration of Response (DR)

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outcome · POSTED

Time to Tumor Response (TTR)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Overall Progression Free Survival

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outcome · POSTED

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Primary Inclusion Criteria: * Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content. * Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging \[MRI\]). * KPS of greater than or equal to 70% at Screening. * Life expectancy of at least 3 months Primary Exclusion Criteria: * Sarcomatous type of mesothelioma * Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted. * Confirmed presence of CNS tumor involvement. * Evidence of other active malignancy requiring treatment.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
    intervention Names
    1. Drug: MORAb-009 (Amatuximab)
    2. Drug: Pemetrexed
    3. Drug: Cisplatin
    label
    Open Label
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Open Label
    description
    MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
    name
    MORAb-009 (Amatuximab)
    type
    DRUG
  2. arm Group Labels
    1. Open Label
    description
    Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
    name
    Pemetrexed
    type
    DRUG
  3. arm Group Labels
    1. Open Label
    description
    Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
    name
    Cisplatin
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
89
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    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.
    measure
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
    time Frame
    From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
    time Frame
    Month 6
secondary Outcomes
  1. description
    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.
    measure
    Overall Response Rate (ORR)
    time Frame
    From the date of first dose until evidence of CR or PR, up to approximately 5 years
  2. description
    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.
    measure
    Duration of Response (DR)
    time Frame
    From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
  3. description
    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.
    measure
    Time to Tumor Response (TTR)
    time Frame
    From the date of the first dose to first documentation of objective response, up to approximately 5 years
  4. description
    OS was defined as the time from the date of the first dose of amatuximab to the date of death.
    measure
    Overall Survival (OS)
    time Frame
    From the date of first dose to the date of death, up to approximately 5 years
  5. description
    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.
    measure
    Overall Progression Free Survival
    time Frame
    From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
Full study description
brief Summary
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-2e0ac63521464428872a
      requested nct id
      NCT00738582
      primary nct id
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      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      payload sha256
      b94d72b73328f87f77e729eeb18592ded32b23c1165cd13edc1fb9eb468299f9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-2e0ac63521464428872a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00738582
      occurrences
      1. context exact
        NCT00738582
        end
        11
        exact text
        NCT00738582
        start
        0
      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
      /studies/9/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2cb59c672f9255395da1fb97d689b848fb5a4014d2754bffd20a5a72c8c6d7cf

    Preserved source evidence · Not medical advice