A Study of Gemcitabine Plus OMP-21M18 as 1st-line Treatment in Subjects With Pancreatic Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01189929
• Date of registration: 25/08/2010
• Primary sponsor: OncoMed Pharmaceuticals, Inc.
• Public title: A Study of Gemcitabine Plus OMP-21M18 as 1st-line Treatment in Subjects With Pancreatic Cancer
• Scientific title: A Phase 1b Study of Gemcitabine Plus OMP-21M18 as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer
• Date of first enrolment: August 2010
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01189929
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, New Zealand, Spain

Contacts

• Name: Robert Stagg, PharmD

Key inclusion & exclusion criteria

Inclusion criteria

1. 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.

2. Age >21 years

3. Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix B)

4. Life expectancy of more than 3 months

5. 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

6. 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.

7. 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:

1. Subjects receiving any other investigational agents or anti-cancer therapy.

2. 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

3. History of a significant allergic reaction attributed to humanized or human
monoclonal antibody therapy

4. 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

5. Pregnant women or nursing women

6. Subjects with known HIV infection

7. Known bleeding disorder or coagulopathy

8. Subjects receiving heparin, warfarin, or other similar anticoagulants. Note:
Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory
agents.

9. Subjects with known clinically significant gastrointestinal disease including, but
not limited to, inflammatory bowel disease

10. New York Heart Association Classification II, III, or IV

11. 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.

12. Subjects with tumors that are currently involving the lumen of the gastrointestinal
tract

13. 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

14. 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Cancer

Intervention(s)

Drug: OMP-21M18

Primary Outcome(s)

- To determine the maximum tolerated dose of OMP-21M18 when combined with gemcitabine [Time Frame: Until disease progression]

Secondary Outcome(s)

To determine population pharmacokinetics [Time Frame: Until disease progression]

To determine the exploratory biomarker changes of gemcitabine plus OMP-21M18 [Time Frame: Until disease progression]

To determine the preliminary efficacy of gemcitabine plus OMP-21M18 [Time Frame: Until disease progression]

To determine the rate of immunogenicity of gemcitabine plus OMP-21M18 [Time Frame: Until disease progression]

To determine the safety of gemcitabine plus OMP-21M18 [Time Frame: Until disease progression]

Secondary ID(s)

M18-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novotech (Australia) Pty Ltd