Malignant Pleural MesotheliomaPhase 2AmatuximabNCT00738582
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
A Phase 2 study testing MORAb-009 (Amatuximab), Pemetrexed and Cisplatin in people with Malignant Pleural Mesothelioma, run by Morphotek at 28 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- MORAb-009 (Amatuximab), Pemetrexed and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 31 Dec 2008to 10 Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States12 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21201
NIH/National Cancer Institute
Bethesda, Maryland, 20892
University of Alabama, Birmingham
Birmingham, Alabama, 35294
University of Chicago Medical Center
Chicago, Illinois, 60637
University of California, San Diego
La Jolla, California, 92093
UCLA Medical Hematology & Oncology
Los Angeles, California, 90095
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
Columbia University Medical Center
New York, New York, 10032
Christiana Care Health System
Newark, Delaware, 19713
University of California, San Francisco
San Francisco, California, 94115
Germany7 sites
HELIOS Klinikum Emil von Behring
Berlin, 14165
Asklepios Fachkliniken Müchen-Gauting
Gauting, 82131
Krankenhaus Großhansdorf
Großhansdorf, 22927
Asklepios Klinik Harburg
Hamburg, 21075
Medizinsche Hochschule Hannover
Hanover, 30625
Fachklinik für Lungenerkrankungen Immenhausen
Immenhausen, 34376
Medizinische Klinik (Hämatologie/Onkologie)
München, 81657
Spain5 sites
H. de la Santa Creu i Sant Pau
Barcelona, 08025
Consorci Sanitari Parc Taulí
Barcelona, 08208
H. Son Dureta
Palma de Mallorca, 07014
Clínica Universitaria de Navarra
Pamplona, 31008
H. Virgen del Rocío
Seville, 41013
Canada2 sites
Hopital Laval
Quebec, PQ, G1V 3E6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Netherlands2 sites
Medisch Spectrum Twente
Enschede, 7513 ER
Erasmus MC
Rotterdam, 3015 CE
About this study
Official title: An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
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.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- MORAb-009 (Amatuximab), Pemetrexed, Cisplatin
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-009 (Amatuximab)Drug
MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
PemetrexedDrug
Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
CisplatinDrug
Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Pemetrexed, Cisplatin and MORAb-009 (Amatuximab) Receives: Drug: MORAb-009 (Amatuximab); Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at 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.
Measured: Month 6
Secondary outcomes (5)
Overall Response Rate (ORR)
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.
Measured: From the date of first dose until evidence of CR or PR, up to approximately 5 years
Duration of Response (DR)
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.
Measured: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years
Time to Tumor Response (TTR)
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.
Measured: From the date of the first dose to first documentation of objective response, up to approximately 5 years
Overall Survival (OS)
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
Measured: From the date of first dose to the date of death, up to approximately 5 years
Overall Progression Free Survival
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.
Measured: From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study start31 Dec 2008
- Primary completion30 Jun 2011
- Study completion10 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Wallin, MD, Study director, Morphotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738582
- Sponsor's protocol ID
- MORAb-009-003 Amatuximab
- Other IDs
- 2008-005448-18, 2008
- Acronym
- Amatuximab
- Status last verified
- Nov 2015
- First submitted
- 19 Aug 2008
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
- ClinicalTrials.gov ID
- NCT00738582
- Acronym / sponsor ID
- Amatuximab / MORAb-009-003 Amatuximab
- Conditions
- Malignant Pleural Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2008 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: MORAb-009 (Amatuximab), Drug: Pemetrexed, Drug: CisplatinPemetrexed, Cisplatin and MORAb-009 (Amatuximab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORAb-009 (Amatuximab)MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles. | Drug | Open Label |
| PemetrexedPemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles | Drug | Open Label |
| CisplatinCisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles | Drug | Open Label |
Primary outcome
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
Time frame: 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.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: From the date of first dose until evidence of CR or PR, up to approximately 5 years
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
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
Overall Survival (OS)
Time frame: From the date of first dose to the date of death, up to approximately 5 years
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Wallin, MD study director
Morphotek
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORAb-009 (Amatuximab), Pemetrexed and Cisplatin in people with Malignant Pleural Mesothelioma, run by Morphotek at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Spain, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.