Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

NCT02109445

Last updated date
Study Location
Anschutz Inpatient Pavilion
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Cancer Pancreas
Sex
Females and Males
Age
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.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Metastatic Cancer PancreasStudy Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT02109445
  1. Aurora, Colorado
  2. Aurora, Colorado
  3. Aurora, Colorado
  4. Rochester, New York
  5. Rochester, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: PF-03084014
    Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID
  • Drug: Gemcitabine
    Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
  • Drug: Nab-paclitaxel
    Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
    Other Name: Abraxane
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Phase 1
    PF-03084014 in combination with gemcitabine and nab-paclitaxel
    Interventions:
    • Drug: PF-03084014
    • Drug: Gemcitabine
    • Drug: Nab-paclitaxel
  • Experimental: Phase 2 Arm A
    PF-03084014 in combination with gemcitabine and nab-paclitaxel
    Interventions:
    • Drug: PF-03084014
    • Drug: Gemcitabine
    • Drug: Nab-paclitaxel
  • Active Comparator: Phase 2 Arm B
    Gemcitabine plus nab-Paclitaxel
    Interventions:
    • Drug: Gemcitabine
    • Drug: Nab-paclitaxel
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
 (submitted: July 28, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Academic GI Cancer Consortium (AGICC)
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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