Trial · NCT02109445
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT02109445, Phase 2, Terminated, Pfizer; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies. Trials, record NCT02109445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02109445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
- NCT number
- NCT02109445
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Metastatic Cancer Pancreas
- Interventions
- PF-03084014, Gemcitabine, Nab-paclitaxel, PF-03084014, Gemcitabine, Nab-paclitaxel, Gemcitabine, Nab-paclitaxel
- First posted
- 2014-04-09
- Last updated
- 2019-01-10
- Other registries' IDs
- eudract:2013-005574-21
- Results first posted
- 2017-06-12
- Limitations and caveats
- Due to early termination of the study, only 3 participants were enrolled. Phase 2 was not carried out. As such, there is limited data for Phase 1 and no data for Phase 2.
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | Cycle 1 (28 days) | DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. |
| Primary | Overall Survival (OS) in Phase 2 | From start of study treatment, collected every 3 months until death (up to 5 years) | Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. |
| Secondary | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | Baseline up to 28-35 days post last administration of study drug | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening. |
| Secondary | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2 | Baseline up to 28-35 days post last administration of study drug | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening. |
| Secondary | Number of Participants With Laboratory Abnormalities in Phase 1 | Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy\[if urine tested positive for blood or protein\]). |
| Secondary | Number of Participants With Laboratory Abnormalities in Phase 2 | Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy\[if urine tested positive for blood or protein\]). |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2 | Baseline up to 28-35 days after treatment discontinuation | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate, weight and body surface area. |
| Secondary | Number of Participants With Worsening QTc Results in Phase 1 | Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (\>=) 501 msec on at least 2 seperate ECGs=Grade 3, \>=501 or more than (\>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4. |
| Secondary | Number of Participants With Worsening QTc Results in Phase 2 | Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (\>=) 501 msec on at least 2 seperate ECGs=Grade 3, \>=501 or more than (\>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4. |
| Secondary | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast). |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | Cycle 1 (28 days) | All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs. | participants | NUMBER |
| PRIMARY | Overall Survival (OS) in Phase 2 | From start of study treatment, collected every 3 months until death (up to 5 years) | All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | Baseline up to 28-35 days post last administration of study drug | All enrolled participants in Phase 1 who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2 | Baseline up to 28-35 days post last administration of study drug | No participants were analyzed since Phase 2 was not performed. | ||
| SECONDARY | Number of Participants With Laboratory Abnormalities in Phase 1 | Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug | All participants who received any study treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities in Phase 2 | Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug | Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis. | ||
| SECONDARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2 | Baseline up to 28-35 days after treatment discontinuation | All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed. | ||
| SECONDARY | Number of Participants With Worsening QTc Results in Phase 1 | Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment | All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014. | participants | NUMBER |
| SECONDARY | Number of Participants With Worsening QTc Results in Phase 2 | Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment | Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure. | ||
| SECONDARY | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | nanogram*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | 2 | participants | ||
| Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | All-causality TEAEs | 3 | participants | |
| Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | Treatment-related TEAEs | 3 | participants | |
| Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | Grade 3 or 4 TEAEs | 3 | participants | |
| Number of Participants With Laboratory Abnormalities in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | 3 | participants | ||
| Number of Participants With Worsening QTc Results in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | NA | participants | ||
| Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | AUClast for PF-03084014 on Day 3 (n=3) | 1122 | Geometric Coefficient of Variation 913 | nanogram*hour/milliliter (ng*hr/mL) |
| Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | AUClast for PF-03084014 on Day 15 (n=1) | 1770 | Geometric Coefficient of Variation NA | nanogram*hour/milliliter (ng*hr/mL) |
| Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | AUCinf for nab-paclitaxel on Day 1 (n=3) | 5774 | Geometric Coefficient of Variation 11 | nanogram*hour/milliliter (ng*hr/mL) |
| Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | AUClast for nab-paclitaxel on Day 1 (n=3) | 5185 | Geometric Coefficient of Variation 9 | nanogram*hour/milliliter (ng*hr/mL) |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03084014+Nab-Paclitaxel+Gemcitabine | 3 | |
| Overall Study | COMPLETED | PF-03084014+Nab-Paclitaxel+Gemcitabine | 0 | |
| Overall Study | NOT COMPLETED | PF-03084014+Nab-Paclitaxel+Gemcitabine | 3 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ascites | Gastrointestinal disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 2 | 3 | |
| other | Vomiting | Gastrointestinal disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 2 | 3 | |
| other | Chills | General disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 1 | 3 | |
| other | Fatigue | General disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 3 | 3 | |
| other | Mucosal inflammation | General disorders | PF-03084014+Nab-Paclitaxel+Gemcitabine | 1 | 3 | |
| other | Candida infection | Infections and infestations | PF-03084014+Nab-Paclitaxel+Gemcitabine | 1 | 3 | |
| other | Fall | Injury, poisoning and procedural complications | PF-03084014+Nab-Paclitaxel+Gemcitabine | 1 | 3 | |
| other | Alanine aminotransferase increased | Investigations | PF-03084014+Nab-Paclitaxel+Gemcitabine | 2 | 3 | |
| other | Aspartate aminotransferase increased | Investigations | PF-03084014+Nab-Paclitaxel+Gemcitabine | 2 | 3 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03084014+Nab-Paclitaxel+Gemcitabine | ||
| Total, other adverse events | PF-03084014+Nab-Paclitaxel+Gemcitabine | 3 | 3 |
| Total, serious adverse events | PF-03084014+Nab-Paclitaxel+Gemcitabine | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02109445
GET https://conductscience.org/api/trials/v1/NCT02109445/registered?page=2