Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT02109445
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- Histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the pancreas.
- 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
- Symptomatic brain metastases requiring steroids
- 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
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Descriptive Information | |||||||
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Brief Title ICMJE | Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies | ||||||
Official Title ICMJE | PHASE 1/2 STUDY OF PF-03084014 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA | ||||||
Brief Summary | This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Metastatic Cancer Pancreas | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 3 | ||||||
Original Estimated Enrollment ICMJE | 193 | ||||||
Actual Study Completion Date ICMJE | November 6, 2014 | ||||||
Actual Primary Completion Date | November 6, 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02109445 | ||||||
Other Study ID Numbers ICMJE | A8641019 2013-005574-21 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Academic GI Cancer Consortium (AGICC) | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |