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

Last updated on August 9, 2018

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

NCT02109445
Pfizer
Terminated
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

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Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
Phase 1/2 Study Of Pf-03084014 In Combination With Gemcitabine And Nab-paclitaxel In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Cancer Pancreas
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
November 6, 2014
November 6, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02109445
A8641019
2013-005574-21 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Academic GI Cancer Consortium
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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