Trial · NCT00878189
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| 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. |
| Secondary | Area Under the Time-Concentration Curve From Time 0 to the Dosing Interval (AUCtau) 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) | AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). CV is the coefficient of variation. |
| Secondary | Dose-normalized AUCtau [AUCtau (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) | AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. NE is not estimable. |
| Secondary | Time to Reach Cmax (Tmax) 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) | Tmax was the time to reach maximum serum concentration (Cmax). |
| Secondary | Cmax After Multiple Dose on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Cmax was the maximum observed serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. CV is the coefficient of variation. |
| Secondary | Time to Reach Cmax (Tmax) After Multiple Dose on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Tmax was the time to reach maximum serum concentration (Cmax). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
| Secondary | AUCtau After Multiple Dose on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
| Secondary | Apparent Volume of Distribution (Vz/F) on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
| Secondary | Serum Decay Half-Life (t1/2) After Multiple Dose on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Serum decay half-life (t1/2) is the time measured for the serum concentration to decrease by one half. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
| Secondary | Apparent Oral Clearance (CL/F) on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
| Secondary | Minimum Observed Serum Concentration (Cmin) After Multiple Dose on Cycle 1 Day 21 | Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose) | Cmin was the minimum serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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