Back to resultsA Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Carcinoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-05212384
FOLFIRI regimen
Bevacizumab
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Advanced colorectal carcinoma.
- Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
- Tumor tissue available at time of screening for molecular profiling.
- Adequate performance status.
- Adequate glucose control, bone marrow, kidney, liver, and heart function.
Exclusion Criteria:
- Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
- Prior irinotecan treatment.
- Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
- History of Gilbert's syndrome.
- Active brain metastases.
- Deep vein thrombosis in the preceding 2 months.
- History of interstitial lung disease.
- RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
Sites / Locations
- St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
- UCLA Hematology Oncology
- Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.
- Drug Management Only: UCLA West Medical Pharmacy
- UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D.
- Ronald Reagan UCLA Medical Center
- Ronald Regan UCLA Medical Center, Drug Information Center
- TRIO-US Central Administration, Regulatory Management Only
- TRIO-US Central Administration
- TRIO_US
- UCLA Hematology Oncology Administrative Address
- Westwood Bowyer Clinic, Peter Morton Medical Building
- West Valley Hematology/Oncology Med Group
- UCLA/Pasadena Healthcare
- Central Coast Medical Oncology Corporation
- UCLA Hematology Oncology
- UCLA Santa Monica Medical Center & Orthopaedic Hospital
- UCLA/Santa Clarita Valley Cancer Center
- UCLA Cancer Center
- Comprehensive Cancer Centers of Nevada Research Department
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of NV
- COmprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers for Nevada
- Metrohealth Medical Center
- Medical Group of the Carolinas - Hematology Spartanburg
- Spartanburg Regional Medical Center
- Kadlec Clinic Hematology and Oncology
- Kadlec Medical Center
- Outpatient Imaging Center
- Investigational Drug Services
- Virginia Mason Medical Center
- Spokane Valley Cancer Center
- Medical Oncology Associates, PS
- The Ottawa Hospital Cancer Centre
- Princess Margaret Cancer Centre
- Hospital Universitari Vall d'Hebron
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
PF-05212384 plus FOLFIRI
Bevacizumab plus FOLFIRI
Outcomes
Primary Outcome Measures
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy
DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).
Progression-Free Survival (PFS)
Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Outcome Measures
Number of Participants With Best Overall Response (Phase 1B)
Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.
Number of Participants With All Causality AEs by System Organ Class (SOC)
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.
Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.
Number of Participants With Hematological Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.
Number of Participants With Coagulation Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.
Number of Participants With Chemistry Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.
Number of Participants With Urinalysis Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.
Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil
Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil
Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil
Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan
Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan
Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan
Terminal Elimination Half-Life of PF-05212384 and Irinotecan
Number of Participants Meeting Maximum Post-Baseline QTc Interval Values
Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.
Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue
Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue
Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Number of Participants With Best Overall Response (Phase 2)
Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).
Duration of Response (Phase 2)
Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.
Overall Survival (Phase 2)
Overall survival is the time from randomization date to date of death due to any cause.
Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)
Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)
The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01937715
Brief Title
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Official Title
An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
B2151007 was prematurely discontinued due to Pfizer's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.
The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
PF-05212384 plus FOLFIRI
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Bevacizumab plus FOLFIRI
Intervention Type
Drug
Intervention Name(s)
PF-05212384
Intervention Description
PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Description
The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Intervention Description
5 mg/m^2 every 2 weeks or 7.5 mg/m^2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
Full dose FOLFIRI regimen every 2 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy
Description
DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).
Time Frame
Day 1 up to Day 28
Title
Progression-Free Survival (PFS)
Description
Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame
Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Best Overall Response (Phase 1B)
Description
Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).
Time Frame
Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose
Title
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.
Time Frame
Baseline up to final study evaluation (within 28 days of last dose)
Title
Number of Participants With All Causality AEs by System Organ Class (SOC)
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.
Time Frame
Baseline up to final study evaluation (within 28 days of last dose)
Title
Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.
Time Frame
Baseline up to final study evaluation (within 28 days of last dose)
Title
Number of Participants With Hematological Test Abnormalities
Description
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.
Time Frame
Day 1 and Day 15 of each cycle
Title
Number of Participants With Coagulation Test Abnormalities
Description
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.
Time Frame
Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Title
Number of Participants With Chemistry Test Abnormalities
Description
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.
Time Frame
Day 1 and Day 15 of each cycle
Title
Number of Participants With Urinalysis Test Abnormalities
Description
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.
Time Frame
Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Title
Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil
Description
Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil
Time Frame
PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil
Description
Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil
Time Frame
PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan
Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan
Time Frame
PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Title
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan
Description
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan
Time Frame
PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Title
Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan
Description
Terminal Elimination Half-Life of PF-05212384 and Irinotecan
Time Frame
PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Title
Number of Participants Meeting Maximum Post-Baseline QTc Interval Values
Description
Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.
Time Frame
Baseline, Cycle 1 Day 1, and Cycle 2 Day 2
Title
Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue
Description
Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Time Frame
Baseline and Cycle 2 Day 17
Title
Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue
Description
Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Time Frame
Baseline and Cycle 2 Day 17
Title
Number of Participants With Best Overall Response (Phase 2)
Description
Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).
Time Frame
Day 1 up to Day 28
Title
Duration of Response (Phase 2)
Description
Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.
Time Frame
Day 1 to Day 28
Title
Overall Survival (Phase 2)
Description
Overall survival is the time from randomization date to date of death due to any cause.
Time Frame
Day 1 up to Day 28
Title
Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)
Description
Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.
Time Frame
Baseline and Cycle 2 Day 17
Title
Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)
Description
The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.
Time Frame
Day 1 of each cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced colorectal carcinoma.
Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Tumor tissue available at time of screening for molecular profiling.
Adequate performance status.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Exclusion Criteria:
Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
Prior irinotecan treatment.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
History of Gilbert's syndrome.
Active brain metastases.
Deep vein thrombosis in the preceding 2 months.
History of interstitial lung disease.
RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCLA Hematology Oncology
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7349
Country
United States
Facility Name
Drug Management Only: UCLA West Medical Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7349
Country
United States
Facility Name
UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7349
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ronald Regan UCLA Medical Center, Drug Information Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TRIO-US Central Administration, Regulatory Management Only
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TRIO-US Central Administration
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TRIO_US
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Hematology Oncology Administrative Address
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Westwood Bowyer Clinic, Peter Morton Medical Building
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
West Valley Hematology/Oncology Med Group
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
UCLA/Pasadena Healthcare
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
UCLA Hematology Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Santa Monica Medical Center & Orthopaedic Hospital
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA/Santa Clarita Valley Cancer Center
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
UCLA Cancer Center
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada Research Department
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Comprehensive Cancer Centers of NV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
COmprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers for Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Medical Group of the Carolinas - Hematology Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Kadlec Medical Center
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Outpatient Imaging Center
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Investigational Drug Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Spokane Valley Cancer Center
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8 L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2151007&StudyName=A%20Study%20Of%20PF-05212384%20Plus%20FOLFIRI%20Versus%20Bevacizumab%20Plus%20FOLFIRI%20In%20Metastatic%20Colorectal%20Cancer%20
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
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