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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival (OS)

Outcome Description:

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.

Outcome Time Frame:

1-21 Months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-009-002

NCT ID:

NCT00570713

Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Southern California Permanente Medical GroupDowney, California  90242
Arlington Cancer CenterArlington, Texas  76012
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Sharp Memorial HospitalSan Diego, California  92123
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Kaiser PermanenteSacramento, California  
Gabrail Cancer CenterCanton, Ohio  44718
Palm Beach Institute of Hematology and OncologyBoynton Beach, Florida  33435
Cancer Center of Central ConnecticutSouthington, Connecticut  
Connecticut Oncology & HematologyTorrington, Connecticut  06790
Hematology Oncology Associates of the Palm BeachesLake Worth, Florida  33461
Hematology-Oncology Associates of Illinois, LLCSkokie, Illinois  60076
Carle Clinic Assoc.Urbana, Illinois  61801
Jayne Gurtler, MD, Laura Brinz, MD, & Angelo Russo, MDMetairie, Louisiana  70006
Providence Cancer Center, Oncology, Clinical TrialsSouthfield, Michigan  48075
Arena Oncology Associates, P.C.Lake Success, New York  11042
Hanover Medical Specialists, MDWilmington, North Carolina  28401
South Texas Onocology Hemotology, PASan Antonio, Texas  78229
Providence Western Washington OncologyLacey, Washington  98503
Medical College of Wisconsin Clinical Cancer CenterMilwaukee, Wisconsin  53226