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An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00570713
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : March 27, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Morphotek

Tracking Information
First Submitted Date  ICMJE December 7, 2007
First Posted Date  ICMJE December 11, 2007
Results First Submitted Date December 8, 2011
Results First Posted Date March 27, 2012
Last Update Posted Date September 9, 2015
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Overall survival [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT00570713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
  • Progression-free Survival [ Time Frame: 1-21 Months ]
    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.
  • Best Overall Response Rate [ Time Frame: Baseline to response up to 21 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Progression-free survival; Overall response based on RECIST criteria; Change in Karnofsky Performance Status (KPS) [ Time Frame: One year ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: MORAb-009
    Monoclonal antibody administered once weekly by intravenous injection.
  • Drug: Placebo
    As per package insert.
  • Drug: Gemcitabine
    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 Arms
  • Experimental: MORAb-009
    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.
    Interventions:
    • Drug: MORAb-009
    • Drug: Gemcitabine
  • Active Comparator: Placebo
    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.
    Interventions:
    • Drug: Placebo
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2012)
155
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
152
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
  2. 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.
  3. Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
  4. Karnofsky performance status of greater than or equal to 70 %.
  5. 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.
  6. 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.
  7. 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.

  8. Must be willing and able to provide written informed consent.

Exclusion Criteria:

  1. Known central nervous system (CNS) tumor involvement.
  2. Evidence of other active malignancy requiring treatment.
  3. 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).
  4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
  5. Active serious systemic disease, including active bacterial or fungal infection.
  6. Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
  7. Prior chemotherapy or radiation therapy for their pancreatic cancer.
  8. Breast-feeding, pregnant, or likely to become pregnant during the study.
  9. No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
  10. Known hypersensitivity to a monoclonal antibody or biologic therapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570713
Other Study ID Numbers  ICMJE MORAb-009-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Morphotek
Study Sponsor  ICMJE Morphotek
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Morphotek
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP