Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT ID: NCT02109445
Last Updated: 2019-01-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2014-09-03
2014-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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Phase 1
PF-03084014 in combination with gemcitabine and nab-paclitaxel
PF-03084014
Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
Phase 2 Arm A
PF-03084014 in combination with gemcitabine and nab-paclitaxel
PF-03084014
Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1.
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
Phase 2 Arm B
Gemcitabine plus nab-Paclitaxel
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
Interventions
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PF-03084014
Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
PF-03084014
Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1.
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
Gemcitabine
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
Nab-paclitaxel
Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic disease. Prior adjuvant therapy with 5-FU or gemcitabine (± gemcitabine post radiation) administered as radiosensitizer allowed, provided at least 6 months have elapsed between the last dose and study registration
* Tumor tissue available (Archival 6 months old or de novo biopsy)
* Measurable disease as per RECIST 1.1
* Performance Status (ECOG) 0 or 1
Exclusion Criteria
* Prior therapy with gamma secretase inhibitors or other Notch pathway inhibitor
* Major surgery within 4 weeks of registration in the current study
* Known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients
* Current or anticipated need for food or drugs that are strong/moderate CYP3A4 inhibitors or inducers
* Diagnosis of any second malignancy within 3 years prior to registration
18 Years
ALL
No
Sponsors
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Academic GI Cancer Consortium (AGICC)
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anschutz Inpatient Pavilion
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Colorado Denver, CTO (CTRC)
Aurora, Colorado, United States
University of Rochester Investigational Drug Pharmacy
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-005574-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8641019
Identifier Type: -
Identifier Source: org_study_id
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