Metastatic Colorectal CarcinomaPhase 1/2NCT01937715
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
A Phase 1/2 study testing PF-05212384, FOLFIRI regimen and Bevacizumab in people with Metastatic Colorectal Carcinoma, run by Pfizer at 39 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma
- What is being tested?
- PF-05212384, FOLFIRI regimen and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Feb 2014to Aug 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States35 sites
Metrohealth Medical Center
Cleveland, Ohio, 44109
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada Research Department
Henderson, Nevada, 89014
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
UCLA Hematology Oncology
Irvine, California, 92604
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Comprehensive Cancer Centers of NV
Las Vegas, Nevada, 89128
COmprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Comprehensive Cancer Centers for Nevada
Las Vegas, Nevada, 89169
Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.
Los Angeles, California, 90095-7349
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles, California, 90095-7349
UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D.
Los Angeles, California, 90095-7349
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Ronald Regan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095
TRIO-US Central Administration, Regulatory Management Only
Los Angeles, California, 90095
TRIO-US Central Administration
Los Angeles, California, 90095
TRIO_US
Los Angeles, California, 90095
UCLA Hematology Oncology Administrative Address
Los Angeles, California, 90095
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California, 90095
West Valley Hematology/Oncology Med Group
Northridge, California, 91328
UCLA/Pasadena Healthcare
Pasadena, California, 91105
Kadlec Medical Center
Richland, Washington, 99352
Outpatient Imaging Center
Richland, Washington, 99352
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
UCLA Hematology Oncology
Santa Monica, California, 90404
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404
Investigational Drug Services
Seattle, Washington, 98101
Virginia Mason Medical Center
Seattle, Washington, 98101
Medical Group of the Carolinas - Hematology Spartanburg
Spartanburg, South Carolina, 29303
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Medical Oncology Associates, PS
Spokane, Washington, 99208
Spokane Valley Cancer Center
Spokane Valley, Washington, 99216
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, 91355
UCLA Cancer Center
Westlake Village, California, 91361
Canada2 sites
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8 L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28009
About this study
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
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.
- Conditions
- Metastatic Colorectal Carcinoma
- Being tested
- PF-05212384, FOLFIRI regimen, Bevacizumab, FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05212384Drug
PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
FOLFIRI regimenDrug
The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
BevacizumabBiological
5 mg/m^2 every 2 weeks or 7.5 mg/m^2 every 3 weeks
FOLFIRIDrug
Full dose FOLFIRI regimen every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | PF-05212384 plus FOLFIRI Receives: Drug: PF-05212384; Drug: FOLFIRI regimen |
| Arm B | Active comparator | Bevacizumab plus FOLFIRI Receives: Biological: Bevacizumab; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 up to Day 28
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.
Measured: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)
Secondary outcomes (21)
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).
Measured: Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose
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.
Measured: Baseline up to final study evaluation (within 28 days of last dose)
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.
Measured: Baseline up to final study evaluation (within 28 days of last dose)
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.
Measured: Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With Hematological Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.
Measured: Day 1 and Day 15 of each cycle
Number of Participants With Coagulation Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.
Measured: Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Number of Participants With Chemistry Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.
Measured: Day 1 and Day 15 of each cycle
Number of Participants With Urinalysis Test Abnormalities
Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.
Measured: Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil
Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil
Measured: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
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
Measured: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
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
Measured: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
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
Measured: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan
Terminal Elimination Half-Life of PF-05212384 and Irinotecan
Measured: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
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.
Measured: Baseline, Cycle 1 Day 1, and Cycle 2 Day 2
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.
Measured: Baseline and Cycle 2 Day 17
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.
Measured: Baseline and Cycle 2 Day 17
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).
Measured: Day 1 up to Day 28
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.
Measured: Day 1 to Day 28
Overall Survival (Phase 2)
Overall survival is the time from randomization date to date of death due to any cause.
Measured: Day 1 up to Day 28
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.
Measured: Baseline and Cycle 2 Day 17
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.
Measured: Day 1 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937715
- Sponsor's protocol ID
- B2151007
- Other IDs
- 2013-002096-18
- Status last verified
- Jul 2016
- First submitted
- 27 Aug 2013
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01937715
- Acronym / sponsor ID
- B2151007
- Conditions
- Metastatic Colorectal Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 18 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PF-05212384, Drug: FOLFIRI regimenPF-05212384 plus FOLFIRI |
| Arm B | Active comparator | Biological: Bevacizumab, Drug: FOLFIRIBevacizumab plus FOLFIRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-05212384PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly | Drug | Arm A |
| FOLFIRI regimenThe RP2D/MTD dose of FOLFIRI regimen every 2 weeks | Drug | Arm A |
| Bevacizumab5 mg/m^2 every 2 weeks or 7.5 mg/m^2 every 3 weeks | Biological | Arm B |
| FOLFIRIFull dose FOLFIRI regimen every 2 weeks | Drug | Arm B |
Primary outcome
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy
Time frame: Day 1 up to Day 28
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)
Time frame: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)
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.
21 secondary outcomes
Number of Participants With Best Overall Response (Phase 1B)
Time frame: Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness
Time frame: Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With All Causality AEs by System Organ Class (SOC)
Time frame: Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade
Time frame: Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With Hematological Test Abnormalities
Time frame: Day 1 and Day 15 of each cycle
Number of Participants With Coagulation Test Abnormalities
Time frame: Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Number of Participants With Chemistry Test Abnormalities
Time frame: Day 1 and Day 15 of each cycle
Number of Participants With Urinalysis Test Abnormalities
Time frame: Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles
Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil
Time frame: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil
Time frame: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan
Time frame: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan
Time frame: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan
Time frame: PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.
Number of Participants Meeting Maximum Post-Baseline QTc Interval Values
Time frame: Baseline, Cycle 1 Day 1, and Cycle 2 Day 2
Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue
Time frame: Baseline and Cycle 2 Day 17
Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue
Time frame: Baseline and Cycle 2 Day 17
Number of Participants With Best Overall Response (Phase 2)
Time frame: Day 1 up to Day 28
Duration of Response (Phase 2)
Time frame: Day 1 to Day 28
Overall Survival (Phase 2)
Time frame: Day 1 up to Day 28
Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)
Time frame: Baseline and Cycle 2 Day 17
Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)
Time frame: Day 1 of each cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Metastatic Colorectal Carcinoma
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PF-05212384, FOLFIRI regimen and Bevacizumab in people with Metastatic Colorectal Carcinoma, run by Pfizer at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy (time frame: Day 1 up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.