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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00570713
First received: December 7, 2007
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: MORAb-009
Drug: Placebo
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 1-21 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 1-21 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 155
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: MORAb-009
Monoclonal antibody administered once weekly by intravenous injection.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570713

  Show 45 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00570713     History of Changes
Other Study ID Numbers: MORAb-009-002
Study First Received: December 7, 2007
Results First Received: December 8, 2011
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 29, 2014