Status:
COMPLETED
A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
OncoMed Pharmaceuticals, Inc.
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety and determine the optimal dose of a new experimental drug, demcizumab (OMP-21M18), when given in combination with gemcitabine with or without (+/-) Abra...
Detailed Description
Current cancer therapies often produce an initial reduction in tumour size but may not have long term benefits. One possible explanation for this is the presence cancer cell known as a cancer stem cel...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects must have histologically or cytologically confirmed locally advanced or metastatic pancreatic cancer. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on Computed Topography (CT) or Magnetic Resonance Imaging (MRI). Prior chemotherapy or radiotherapy is not allowed.
- Age \>21 years
- Eastern Cooperative Oncology Group (ECOG) performance status \<2 (see Appendix B)
- Life expectancy of more than 3 months
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes \>3.5 x 109/L
- Absolute neutrophil count \>1.25 x 109/L
- Hemoglobin \>100 g/L
- Platelets \>125 X 109/L
- Total bilirubin \<2 X institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \<5 X institutional ULN
- Alkaline phosphatase \<5 X institutional ULN
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within institutional ULN
- Creatinine \<1.5 X institutional ULN OR
- Calculated creatinine clearance \>60 mL/min using the Cockcroft and Gault formula as follows:
- Creatinine clearance (mL/min) = (140 - age) x ideal body weight \[kg\] 0.814 x serum creatinine \[µmol/L\] For women, multiply the value from the equation above by 0.85. Where age is in years, weight is in kg, and serum creatinine is in µmol/L
- Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study drug, the Investigator should be informed immediately.
- Ability to understand and the willingness to sign a written informed consent document
- Exclusion Criteria
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Subjects receiving any other investigational agents or anti-cancer therapy.
- Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
- Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- New York Heart Association Classification II, III, or IV
- Subjects with a blood pressure (BP) of \>140/90 mmHg. Subjects taking antihypertensive medications must be taking ≤2 medications to obtain this level of BP control.
- Subjects with tumors that are currently involving the lumen of the gastrointestinal tract
- Subjects with current evidence of cardiac ischemia or heart failure within the last 6 months, subjects who are receiving any medications for cardiac ischemia, subjects with a B-type natriuretic peptide (BNP) value of \>100 pg/mL, subjects with a LVEF of \<50%, subjects with pulmonary hypertension defined as a peak tricuspid velocity \>3.4 m/s on doppler echocardiogram or subjects that have received a total cumulative dose of ≥400 mg/m2 doxorubicin
- Subjects with electrocardiogram (ECG) evidence of ischemia or ≥ Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01189929
Start Date
August 1 2010
End Date
December 1 2016
Last Update
September 9 2020
Active Locations (6)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
3
The Austin Hospital
Heidelberg, Victoria, Australia
4
Christchurch Hospital
Christchurch, New Zealand