Trial · NCT01876251
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
NCT01876251, Phase 1, Terminated, Pfizer; results first posted 2019-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer. Trials, record NCT01876251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876251
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
- NCT number
- NCT01876251
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Breast Cancer Metastatic
- Interventions
- PF-03084014, PF-03084014, PF-03084014, Docetaxel, Docetaxel
- First posted
- 2013-06-12
- Last updated
- 2019-03-15
- Other registries' IDs
- eudract:2013-000659-41
- Results first posted
- 2019-03-15
Source ClinicalTrials.gov
Registered outcomes21
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 Days 1-21 | Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia (Grade more than or equal to \[\>=\] 3 and body temperature \>=38.5 degrees Celsius); Grade \>=3 neutropenic infection; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade \>=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities. |
| Primary | Progression-free Survival (PFS) at 6 Months - Expansion Cohort | Baseline till 6 months post-dose | The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Secondary | Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. 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. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE. |
| Secondary | Number of Participants With Laboratory Abnormalities | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick). |
| Secondary | Percentage of Participants With Objective Response (OR) | Baseline, every 6 weeks from Cycle 2 onwards up to 26 months | OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 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 millimeters \[mm\]). 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, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Secondary | Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort | Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12) | Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1). |
| Secondary | AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| Secondary | Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1) |
| Secondary | Cmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1) |
| Secondary | Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 Days 1-21 | All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period. | participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) at 6 Months - Expansion Cohort | Baseline till 6 months post-dose | The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m\^2). Due to early study termination, only 7 participants were treated in the expansion cohort. | months | MEDIAN |
| SECONDARY | Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | All 29 participants who received study treatment were included in the AE summarization/analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Baseline up to 28-35 days after treatment discontinuation (up to Day 280) | All 29 participants who received study treatment were included in the safety analyses. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Baseline, every 6 weeks from Cycle 2 onwards up to 26 months | All 29 participants who received study treatment were included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort | Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | nanogram (ng)*hour (hr)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | nanogram (ng)*hour (hr)/milliliter (mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Docetaxel in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort | C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12) | All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point. | hr | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group237
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 100 mg BID + Docetaxel 75 mg/m^2 | 1 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 1 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 4 | participants | ||
| Progression-free Survival (PFS) at 6 Months - Expansion Cohort | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 4.1 | 95% Confidence Interval 1.3 to 8.1 | months | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | All causality TEAEs | 15 | participants | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | All causality TEAEs | 3 | participants | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | All causality TEAEs | 11 | participants | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | Treatment-related (TR) TEAEs | 15 | participants | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | Treatment-related (TR) TEAEs | 3 | participants | |
| Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | Treatment-related (TR) TEAEs | 11 | participants |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 15 | |
| Overall Study | STARTED | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 3 | |
| Overall Study | STARTED | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 11 | |
| Overall Study | COMPLETED | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 0 | |
| Overall Study | COMPLETED | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 0 | |
| Overall Study | COMPLETED | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 15 | |
| Overall Study | NOT COMPLETED | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 3 | |
| Overall Study | NOT COMPLETED | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 11 |
Source ClinicalTrials.gov
Adverse events531
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 | Anaemia | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 10 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 5 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 3 | 15 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 1 | 3 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 0 | 11 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 0 | 15 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 0 | 3 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 1 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 10 | 15 |
1 to 10 of 531Source ClinicalTrials.gov
See all 531 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | ||
| Total, all-cause mortality | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | ||
| Total, all-cause mortality | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | ||
| Total, other adverse events | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 15 | 15 |
| Total, other adverse events | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 3 | 3 |
| Total, other adverse events | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 11 | 11 |
| Total, serious adverse events | PF-03084014 100 mg BID + Docetaxel 75 mg/m^2 | 4 | 15 |
| Total, serious adverse events | PF-03084014 100 mg BID + Docetaxel 100 mg/m^2 | 3 | 3 |
| Total, serious adverse events | PF-03084014 150 mg BID + Docetaxel 75 mg/m^2 | 6 | 11 |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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