Trial · NCT00878189
A Trial In Patients With Advanced Cancer And Leukemia
NCT00878189, Phase 1, Completed, Pfizer; results first posted 2019-11-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial In Patients With Advanced Cancer And Leukemia. Trials, record NCT00878189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878189
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial In Patients With Advanced Cancer And Leukemia
- NCT number
- NCT00878189
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 72 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Neoplasms by Histologic Type
- Interventions
- PF-03084014
- First posted
- 2009-04-08
- Last updated
- 2019-11-12
- Other registries' IDs
- eudract:2010-022036-36
- Results first posted
- 2019-11-12
- Limitations and caveats
Study components related to combination therapy with dexamethasone were removed due to operational/scientific reasons. Due to halting of T-AA/LBL participant's enrollment; limited number of evaluable participants, PBR and RFS data was not collected.
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | Baseline to the end of Cycle 1 (Week 4) | Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia \>7 days; febrile neutropenia; neutropenic infection; Grade \>=3 thrombocytopenia with bleeding |
| Primary | Number of T-ALL/LBL Participants With First-Cycle DLT | Baseline to the end of Cycle 1 (Week 4) | Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) \<1000/microliter (uL), or platelet count \<30,000/uL, or hemoglobin \<8 gram/deciliter (g/dL) in a bone marrow with \<5% blasts and no evidence of leukemia or abnormal dysplasia for \>42 days |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) | Baseline up to end of study (maximum of 84 months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of casual relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect. |
| Secondary | Number of Participants With TEAEs (Treatment-Related) | Baseline up to end of study (maximum of 84 months) | An AE was any untoward medical occurrence in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) | Baseline up to end of study (maximum of 84 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE. |
| Secondary | Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) | Baseline up to end of study (maximum of 84 months) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE. |
| Secondary | Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval | Baseline up to end of study (maximum of 84 months) | Criteria for potentially important changes in ECG were defined as: maximum (max.) post-dose (post-baseline) time from electrocardiogram Q wave to the corresponding to electrical systole (QT interval) corrected for Fridericia's factor (QTcF), or QT interval corrected for Bazett's factor (QTcB): \<450, 450 -\<480, 480-\<500, and \>=500 msec. Maximum increase (inc.) from baseline in QTcF or QTcB: change (chg) \<30, 30\>=chg\<60, and chg \>=60 msec. |
| Secondary | Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) | Baseline up to end of study (maximum of 84 months) | Parameters analyzed included: white blood cell (WBC) count plus differential, absolute (abs) neutrophil count, platelets, hemoglobin, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, creatinine, glucose, uric acid, calcium, phosphate, magnesium, total protein, albumin, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), partial prothrombin time/international normalized ratio (PTT/INR). Urinalysis: pH, specific gravity, protein, glucose, ketones, blood, leukocyte esterase, and nitrites. Pregnancy test: Serum or urine pregnancy test for women of childbearing potential. There were no changes in urine protein among the solid tumor and T-ALL/LBL participants that were clinically significant. Clinical significance was judged by the investigator. |
| Secondary | Maximum Observed Serum Concentration (Cmax) After a Single Dose on Cycle 1 Day 1 | Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose) | Cmax was the maximum observed serum concentration. |
| Secondary | Dose-normalized Cmax [Cmax (dn)] After a Single Dose on Cycle 1 Day 1 | Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose) | Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | Baseline to the end of Cycle 1 (Week 4) | Solid tumor participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs. | participants | NUMBER |
| PRIMARY | Number of T-ALL/LBL Participants With First-Cycle DLT | Baseline to the end of Cycle 1 (Week 4) | T-ALL/LBL participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs (Treatment-Related) | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) | Baseline up to end of study (maximum of 84 months) | All participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) After a Single Dose on Cycle 1 Day 1 | Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose) | All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this outcome measure (OM). | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Dose-normalized Cmax [Cmax (dn)] After a Single Dose on Cycle 1 Day 1 | Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose) | All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM. | ng/mL/mg | GEOMETRIC_MEAN |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group570
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 20 mg BID in Solid Tumor Participants | 0 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 40 mg BID in Solid Tumor Participants | 0 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 80 mg BID in Solid Tumor Participants | 0 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 100 mg BID in Solid Tumor Participants | 1 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 130 mg BID in Solid Tumor Participants | 0 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 150 mg BID in Solid Tumor Participants | 1 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 220 mg BID in Solid Tumor Participants | 1 | participants | ||
| Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT) | PF-03084014 330 mg BID in Solid Tumor Participants | 2 | participants | ||
| Number of T-ALL/LBL Participants With First-Cycle DLT | PF-03084014 150 mg BID in T-ALL/LBL Participants | 1 | participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) | PF-03084014 20 mg BID in Solid Tumor Participants | No. of Participants With AEs | 3 | participants |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03084014 20 mg BID in Solid Tumor Participants | 3 | |
| Overall Study | STARTED | PF-03084014 40 mg BID in Solid Tumor Participants | 3 | |
| Overall Study | STARTED | PF-03084014 80 mg BID in Solid Tumor Participants | 4 | |
| Overall Study | STARTED | PF-03084014 100 mg BID in Solid Tumor Participants | 8 | |
| Overall Study | STARTED | PF-03084014 130 mg BID in Solid Tumor Participants | 4 | |
| Overall Study | STARTED | PF-03084014 150 mg BID in Solid Tumor Participants | 23 | |
| Overall Study | STARTED | PF-03084014 220 mg BID in Solid Tumor Participants | 16 | |
| Overall Study | STARTED | PF-03084014 330 mg BID in Solid Tumor Participants | 3 | |
| Overall Study | STARTED | PF-03084014 150 mg BID in T-ALL/LBL Participants | 8 | |
| Overall Study | COMPLETED | PF-03084014 20 mg BID in Solid Tumor Participants | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,340
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 | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 20 mg BID in Solid Tumor Participants | 0 | 3 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 40 mg BID in Solid Tumor Participants | 0 | 3 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 80 mg BID in Solid Tumor Participants | 0 | 4 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 100 mg BID in Solid Tumor Participants | 1 | 8 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 130 mg BID in Solid Tumor Participants | 0 | 4 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 150 mg BID in Solid Tumor Participants | 0 | 23 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 150 mg BID in T-ALL/LBL Participants | 0 | 8 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 220 mg BID in Solid Tumor Participants | 1 | 16 | |
| other | PRURITIS | Skin and subcutaneous tissue disorders | PF-03084014 330 mg BID in Solid Tumor Participants | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-03084014 20 mg BID in Solid Tumor Participants | 0 | 3 |
1 to 10 of 2,340Source ClinicalTrials.gov
See all 2,340 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03084014 20 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 40 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 80 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 100 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 130 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 150 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 150 mg BID in T-ALL/LBL Participants | ||
| Total, all-cause mortality | PF-03084014 220 mg BID in Solid Tumor Participants | ||
| Total, all-cause mortality | PF-03084014 330 mg BID in Solid Tumor Participants | ||
| Total, other adverse events | PF-03084014 20 mg BID in Solid Tumor Participants | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00878189
GET https://conductscience.org/api/trials/v1/NCT00878189/registered?page=2