Pancreatic CancerPhase 1NCT00325494
A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer
A Phase 1 study testing MORAb-009 in people with Pancreatic Cancer and Mesothelioma, run by Morphotek at 3 sites in United States.
Trial summary
The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Mesothelioma, Ovarian Cancer
- What is being tested?
- MORAb-009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Female or male subjects, ≥ 18 years of age, with a histologically confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, or mesothelin-positive ovarian or non-small cell lung cancer. As nearly 100% of pancreatic adenocarcinoma and mesotheliomas express mesothelin, immunohistochemical confirmation of mesothelin-positivity is not necessary.
- Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
- Subject must have failed at least one standard chemotherapy regimen. Patients with pancreatic cancer must have received gemcitabine as part of prior therapy and be considered refractory, or in the case of ovarian cancer be considered platinum refractory or resistant.
- Life expectancy ≥ 3 months, as estimated by the investigator.
- Eastern Cooperative Oncology Group performance status or 0, 1 or 2.
- Female subjects of childbearing potential and all male subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after MORAb-009 administration. A barrier method of contraception must be included.
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- Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
- Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Hemoglobin ≥ 9 g/dL; Serum bilirubin ≤ 2.0 mg/dL; Aspartate transaminase (AST) ≤ 5 x upper limit of normal (ULN); Alanine transaminase (ALT) ≤ 5 x ULN; Alkaline Phosphatase ≤ 5 x ULN; Serum creatinine ≤ 2.0 mg/dL. If the elevations of liver functions are due to obstruction of the common bile duct extrinsic to the liver, the subject may be enrolled at the discretion of the investigator even if the elevations are greater than the limits above. Stenting to reduce liver functions to qualifying levels is permitted.
- Subject must be willing and able to provide written informed consent.
Who cannot join
- Known central nervous system (CNS) tumor involvement.
- Evidence of other active malignancy requiring treatment.
- Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
- ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
- Active serious systemic disease, including active bacterial or fungal infection.
- Active hepatitis or HIV infection.
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- Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
- Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to dosing with MORAb-009.
- Breast-feeding, pregnant, or likely to become pregnant during the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
National Cancer Institute
Bethesda, Maryland, 20892-1922
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-expressing Tumors
The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
Read the detailed description
MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane glycoprotein thought to be involved in cell adhesion and tightly associated with a range of cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers, mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers, while showing little expression in normal tissues. Preclinical experiments indicate that MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-009.
- Being tested
- MORAb-009
- Keywords
- Pancreatic Cancer, Mesothelioma, Ovarian Cancer, Non-Small Cell Lung Cancer, Mesothelin
- Medical subject headings
- Pancreatic Neoplasms, Mesothelioma, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-009Drug
Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m^2 up to 400 mg/m^2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | MORAb-009 weekly dose of 12.5 mg/m^2 Receives: Drug: MORAb-009 |
| Cohort 2 | Experimental | MORAb-009 weekly dose of 25 mg/m^2 Receives: Drug: MORAb-009 |
| Cohort 3 | Experimental | MORAb-009 weekly dose of 50 mg/m^2 Receives: Drug: MORAb-009 |
| Cohort 4 | Experimental | MORAb-009 weekly dose of 100 mg/m^2 Receives: Drug: MORAb-009 |
| Cohort 5 | Experimental | MORAb-009 weekly dose of 200 mg/m^2 Receives: Drug: MORAb-009 |
| Cohort 6 | Experimental | MORAb-009 weekly dose of 400 mg/m^2 Receives: Drug: MORAb-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events
Measured: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of clinical laboratory parameters
Measured: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of physical examinations, vital signs, and ECGs
Measured: 35 day treatment and observation period, or until disease progession occurs
Secondary outcomes (3)
Pharmacokinetics of MORAb-009
Blood samples will be analyzed using ELISA for concentration of MORAb-009.
Measured: Pre-dose, mid-infusion, end of infusion, 30 min, 60 min, 2 hours, and 4 hours post dose
Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA])
Measured: 35 day treatment and observation period
Objective Tumor Response Rate Assessed by Investigator
CT; MRI; RECIST criteria; biomarkers
Measured: 35 day treatment and observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan C. Weil, M.D., Study director, Morphotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325494
- Sponsor's protocol ID
- MORAb-009-001
- Status last verified
- Jul 2014
- First submitted
- 11 May 2006
- Last updated
- 17 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-expressing Tumors
- ClinicalTrials.gov ID
- NCT00325494
- Acronym / sponsor ID
- MORAb-009-001
- Keywords
- Pancreatic Cancer, Mesothelioma, Ovarian Cancer, Non-Small Cell Lung Cancer, Mesothelin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
Detailed description
MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane glycoprotein thought to be involved in cell adhesion and tightly associated with a range of cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers, mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers, while showing little expression in normal tissues. Preclinical experiments indicate that MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-009.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 12.5 mg/m^2 |
| Cohort 2 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 25 mg/m^2 |
| Cohort 3 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 50 mg/m^2 |
| Cohort 4 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 100 mg/m^2 |
| Cohort 5 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 200 mg/m^2 |
| Cohort 6 | Experimental | Drug: MORAb-009MORAb-009 weekly dose of 400 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or male subjects, ≥ 18 years of age, with a histologically confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, or mesothelin-positive ovarian or non-small cell lung cancer. As nearly 100% of pancreatic adenocarcinoma and mesotheliomas express mesothelin, immunohistochemical confirmation of mesothelin-positivity is not necessary.
- Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
- Subject must have failed at least one standard chemotherapy regimen. Patients with pancreatic cancer must have received gemcitabine as part of prior therapy and be considered refractory, or in the case of ovarian cancer be considered platinum refractory or resistant.
- Life expectancy ≥ 3 months, as estimated by the investigator.
- Eastern Cooperative Oncology Group performance status or 0, 1 or 2.
Key exclusion criteria (9 listed)
- Known central nervous system (CNS) tumor involvement.
- Evidence of other active malignancy requiring treatment.
- Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
- ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
- Active serious systemic disease, including active bacterial or fungal infection.
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-009Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m^2 up to 400 mg/m^2. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events
Time frame: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of clinical laboratory parameters
Time frame: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of physical examinations, vital signs, and ECGs
Time frame: 35 day treatment and observation period, or until disease progession occurs
3 secondary outcomes
Pharmacokinetics of MORAb-009
Time frame: Pre-dose, mid-infusion, end of infusion, 30 min, 60 min, 2 hours, and 4 hours post dose
Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA])
Time frame: 35 day treatment and observation period
Objective Tumor Response Rate Assessed by Investigator
Time frame: 35 day treatment and observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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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.
Susan C. Weil, M.D. study director
Morphotek
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MORAb-009 in people with Pancreatic Cancer and Mesothelioma, run by Morphotek at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events (time frame: 35 day treatment and observation period, or until disease progession occurs). The study lists 3 primary outcomes in all. 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 17 Jul 2014.