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Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients

Last updated on March 14, 2019

Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Pancreatic Ductal Adenocarcinoma
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Histologically or cytologically proven diagnosis of metastatic ductal adenocarcinoma
of the pancreas.

2. All patients must provide a baseline tumor sample at registration. If an archival
sample is not available, patients must have a metastatic biopsy collected at the
screening visit.

3. Patient must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease.

4. Measurable disease as per RECIST v. 1.1.

5. Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 NCI

6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

7. Age ≥18 years.

8. Adequate Bone Marrow, Renal and liver Functions.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Patients with known symptomatic brain metastases requiring steroids.

2. Prior therapy with modulators of monocyte or TAM function.

3. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4
weeks of registering for the current study and/or during study participation.

4. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell carcinoma, or squamous cell skin carcinoma or in situ cervical

5. Known hypersensitivity to nab-paclitaxel or to gemcitabine or to any of the

6. Any one of the following currently or in the previous 6 months: myocardial infarction,
severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, cerebrovascular accident, transient ischemic attack;
symptomatic pulmonary embolism; congenital long QT syndrome, torsades de points,
arrhythmias (including sustained ventricular tachyarrhythmia and ventricular
fibrillation), right bundle branch block and left anterior hemiblock (bifascicular
block), ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of
any grade, or QTc interval >470 msec at screening.

7. Concurrent administration of herbal preparations.

8. Use of oral anticoagulants. Use of subcutaneous anti coagulation is allowed.
Concurrent use of potent or moderate inhibitors or inducers of CYP3A4 and/or CYP2C8.

9. Active and clinically significant bacterial, fungal or viral infection including
hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or
acquired immunodeficiency syndrome (AIDS) related illness.

10. History of interstitial lung disease, or slowly progressive dyspnea and unproductive
cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
hypersensitivity pneumonitis or multiple allergies.

11. Other severe acute or chronic medical or psychiatric condition, including recent
(within the past year) or active suicidal ideation or behavior) or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the Investigator, would make the patient
inappropriate for entry into this study.

12. Pregnant female patients; breastfeeding female patients; males patients with partners
currently pregnant, male patients able to father children and female patients of
childbearing potential who are unwilling or unable to use two (2) highly effective
methods of contraception as outlined in this protocol for the duration of the study
and for 28 days after last dose of PF-04136309, and for 6 months after last dose of
nab-paclitaxel, gemcitabine, or both.

13. Patients who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
Investigator, or patients who are Pfizer employees directly involved in the conduct of
the trial.

Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients


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