Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Pat… (NCT02732938) | Clinical Trial Compass
TerminatedPhase 2
Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients
Stopped: Pfizer made a business-related decision on 04May2017 to terminate study based on change in portfolio prioritization, and is not due to safety or efficacy.
United States22 participantsStarted 2016-05-04
Plain-language summary
The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309 and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically proven diagnosis of metastatic ductal adenocarcinoma of the pancreas.
✓. 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.
✓. Patient must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
✓. Measurable disease as per RECIST v. 1.1.
✓. Resolved acute effects of any prior therapy to baseline severity or Grade ≤1 NCI CTCAE.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
✓. Age ≥18 years.
✓. Adequate Bone Marrow, Renal and liver Functions.
Exclusion criteria
✕. Patients with known symptomatic brain metastases requiring steroids.
What they're measuring
1
Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b]
Timeframe: Day 1 to Day 28
2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b]
Timeframe: 1 year
3
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b]
Timeframe: 1 year
4
Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b]
Timeframe: 1 year
5
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
Timeframe: 1 year
6
Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
. Prior therapy with modulators of monocyte or TAM function.
✕. 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.
✕. 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 carcinoma.
✕. Known hypersensitivity to nab-paclitaxel or to gemcitabine or to any of the excipients.
✕. 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.
✕. Concurrent administration of herbal preparations.
✕. 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.