Pancreatic CancerPhase 2NCT00570713
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
A Phase 2 study testing MORAb-009 and Gemcitabine in people with Pancreatic Cancer, run by Morphotek at 45 sites in 5 countries.
Trial summary
The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MORAb-009 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 45 sitesin 5 countries
- Study dates
- Dec 2007to Dec 2009
- 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
Who may be able to join
- Female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
- Must have measurable disease, as defined by 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.
- Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
- Karnofsky performance status of greater than or equal to 70 %.
- Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
- 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.
Show all 10Show fewer
- 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 Stenting to reduce liver functions to qualifying levels is permitted.
- Subjects with liver function abnormalities greater than the ULN are eligible only if in the opinion of the investigator they are due to disease obstruction of the bile ducts or metastatic disease.
- 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 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
- Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
- Active serious systemic disease, including active bacterial or fungal infection.
- Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
Show all 10Show fewer
- Prior chemotherapy or radiation therapy for their pancreatic cancer.
- Breast-feeding, pregnant, or likely to become pregnant during the study.
- No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
- Known hypersensitivity to a monoclonal antibody or biologic therapy.
Trial locations and contacts
45 sites in 5 countries.
45 sites in 5 countries
United States26 sites
Arlington Cancer Center
Arlington, Texas, 76012
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
Gabrail Cancer Center
Canton, Ohio, 44718
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
South Carolina Oncology Associates, PA
Columbia, South Carolina, 10595
Baylor College of Medicine
Houston, Texas, 77030
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
Moores UCSD Cancer Center
La Jolla, California, 92037-0845
Providence Western Washington Oncology
Lacey, Washington, 98503
Arena Oncology Associates, P.C.
Lake Success, New York, 11042
Hematology Oncology Associates of the Palm Beaches
Lake Worth, Florida, 33461
Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MD
Metairie, Louisiana, 70006
Medical College of Wisconsin Clinical Cancer Center
Milwaukee, Wisconsin, 53226
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
South Texas Onocology Hemotology, PA
San Antonio, Texas, 78229
Southern California Permanente Medical Group
San Diego, California, 92108
Sharp Memorial Hospital
San Diego, California, 92123
Hematology-Oncology Associates of Illinois, LLC
Skokie, Illinois, 60076
Providence Cancer Center, Oncology, Clinical Trials
Southfield, Michigan, 48075
Cancer Center of Central Connecticut
Southington, Connecticut, 06489
Connecticut Oncology & Hematology
Torrington, Connecticut, 06790
Carle Clinic Assoc.
Urbana, Illinois, 61801
Kaiser Permanente
Vallejo, California, 94589
University of Kansas Medical Center
Westwood, Kansas, 66205
Hanover Medical Specialists, MD
Wilmington, North Carolina, 28401
Germany7 sites
Charité, Universitätsmedizin Berlin
Berlin, D 13353
Stadtische Kliniken Bielefeld-Mitte, Klinik fur Hamatologie und Onkologie
Bielefeld, North Rhine-Westphalia, D 33604
Klinik fuer Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Baden Wurttemburg, D 79106
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
Heidelberg, Baden Wurttemburg, D 69120
SLK-Kliniken Heilbronn GmbH, Medizinische Klinik III
Heilbronn, Baden Wurttemburg, D 74078
II. Medizinische Klinik des Klinikums rechts der Isar
München, Bavaria, D 81675
Universitätsklinikum Ulm, Innere Medizin I
Ulm, Baden Wurttemburg, D 89081
Spain5 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025
Hospital Madrid
Madrid, Madrid, 28010
Hospital Clinico Universitario San Carlos
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Canada4 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
London Regional Cancer Program London Health Sciences Centre
London, Ontario, N6A 4L6
Jewish General Hospital - Montreal
Montreal, Quebec, H2W 1S6
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Belgium3 sites
Centre Hospitalier Jolimont-Lobbes
Haine-Saint-Paul, Hainaut, 7100
Services de gastro-entérologie et d'oncologie, CHC Saint-Joseph
Liège, 4000
AZ Sint Maarten - digestive oncology unit - campus
Mechelen, 2800
About this study
Official title: A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer.
The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- MORAb-009, Placebo, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-009Drug
Monoclonal antibody administered once weekly by intravenous injection.
PlaceboDrug
As per package insert.
GemcitabineDrug
Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
| Study group | Role | What they receive |
|---|---|---|
| MORAb-009 | Experimental | MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Receives: Drug: MORAb-009; Drug: Gemcitabine |
| Placebo | Active comparator | Placebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Receives: Drug: Placebo; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
Measured: 1-21 Months
Secondary outcomes (2)
Progression-free Survival
Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.
Measured: 1-21 Months
Best Overall Response Rate
Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.
Measured: Baseline to response up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570713
- Sponsor's protocol ID
- MORAb-009-002
- Status last verified
- Sep 2015
- First submitted
- 7 Dec 2007
- Last updated
- 9 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Placebo-controlled, Double-blind Study of the Efficacy of MORAb-009 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT00570713
- Acronym / sponsor ID
- MORAb-009-002
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Posted 27 Mar 2012
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 investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORAb-009 | Experimental | Drug: MORAb-009, Drug: GemcitabineMORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. |
| Placebo | Active comparator | Drug: Placebo, Drug: GemcitabinePlacebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. |
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 cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
- Must have measurable disease, as defined by 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.
- Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
- Karnofsky performance status of greater than or equal to 70 %.
- Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
Key exclusion criteria (10 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 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
- Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [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-009Monoclonal antibody administered once weekly by intravenous injection. | Drug | MORAb-009 |
| PlaceboAs per package insert. | Drug | Placebo |
| GemcitabineGemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. | Drug | MORAb-009, Placebo |
Primary outcome
Overall Survival (OS)
Time frame: 1-21 Months
This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
2 secondary outcomes
Progression-free Survival
Time frame: 1-21 Months
Best Overall Response Rate
Time frame: Baseline to response up to 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
45 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 and Gemcitabine in people with Pancreatic Cancer, run by Morphotek at 45 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?
The sponsor lists 10 inclusion and 10 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Germany, Spain, Canada, Belgium. 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 27 Mar 2012). 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?
Overall Survival (OS) (time frame: 1-21 Months). 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 9 Sep 2015.