Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
TerminatedPhase 2Results postedLast updated 10 January 2019
What this trial tests
Phase 2 trial testing PF-03084014 in Metastatic Cancer Pancreas in 3 participants. Terminated before completion.
18 and older, any sex, with Metastatic Cancer Pancreas. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1Primary· 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.
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
2
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1Secondary· 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.
All-causality TEAEs
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
3
Treatment-related TEAEs
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
3
Grade 3 or 4 TEAEs
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
3
Number of Participants With Laboratory Abnormalities in Phase 1Secondary· 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\[if urine tested positive for blood or protein\]).
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
3
Number of Participants With Worsening QTc Results in Phase 1Secondary· 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, mor
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
NA
Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1Secondary· 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).
AUClast for PF-03084014 on Day 3 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
1122
± 913
AUClast for PF-03084014 on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
1770
± NA
AUCinf for nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5774
± 11
AUClast for nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5185
± 9
AUCinf for nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5050
± NA
AUClast for nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
4600
± NA
AUCinf for gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5316
± 172
AUClast for gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5262
± 176
Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1Secondary· 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.
Cmax for PF-03084014 on Day 3 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
527.3
± 710
Cmax for PF-03084014 on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
943.0
± NA
Cmax for nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
6023
± 6
Cmax for nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5140
± NA
Cmax for gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
10760
± 212
Cmax for gemcitabine on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
3620
± NA
Systemic Clearance (CL) of Nab-paclitaxel in Phase 1Secondary· Cycle 1 Days 1-3, and 15-17
Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
37.88
± 25
Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
38.60
± NA
Systemic Clearance (CL) of Gemcitabine in Phase 1Secondary· Cycle 1 Days 1 and 15
Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
5.434
± 165
Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
8.160
± NA
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1Secondary· 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.
Tmax of PF-03084014 on Day 3 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
1.23
0.517 – 4.13
Tmax of PF-03084014 on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.900
NA – NA
Tmax of nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.550
0.517 – 0.583
Tmax of nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.217
NA – NA
Tmax of gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.517
0.250 – 0.533
Tmax of gemcitabine on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.350
NA – NA
Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1Secondary· Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)
Vss of nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
64.46
± 6
Vss of nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
60.80
± NA
Vss of gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
61.76
± 186
Vss of gemcitabine on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
201.0
± NA
Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1Secondary· Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)
t1/2 of nab-paclitaxel on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
2.500
± 0.26851
t1/2 of nab-paclitaxel on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
2.030
± NA
t1/2 of gemcitabine on Day 1 (n=3)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.2813
± 0.14838
t1/2 of gemcitabine on Day 15 (n=1)
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0.2230
± NA
Number of Participants With Objective Response (OR) in Phase 1Secondary· Screening till 28-35 days post last administration of study drug
Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (\<) 10 mm). No new lesions. PR was defined as more than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, w
Group
Value
95% CI
PF-03084014 + Nab-Paclitaxel + Gemcitabine
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through and including 28 calendar days after the last administration of the investigational product..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02299635 — A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
· Phase 2
· terminated
NCT01876251 — A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
· Phase 1
· terminated
NCT01981551 — Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis
· Phase 2
· completed
NCT00878189 — A Trial In Patients With Advanced Cancer And Leukemia
· Phase 1
· completed
NCT02955446 — Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
· no longer available
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 10 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02109445.