Trial · NCT00953758
A Study Of PF-04449913 In Select Hematologic Malignancies
NCT00953758, Phase 1, Completed, Pfizer; results first posted 2024-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of PF-04449913 In Select Hematologic Malignancies. Trials, record NCT00953758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953758
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of PF-04449913 In Select Hematologic Malignancies
- NCT number
- NCT00953758
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hematologic Malignancies
- Interventions
- PF-04449913
- First posted
- 2009-08-06
- Last updated
- 2024-04-25
- Other registries' IDs
- eudract:2009-011285-29
- Results first posted
- 2024-04-25
- Limitations and caveats
- Some participants were administered the lead-in dose at other times (other than Day -6 as stated) due to changes in the timing of the lead-in dose as the protocol was amended a few times.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Cycle 1 Day 1 to end of Cycle 1 (28 days) | Any DLT event in Cycle 1: 1) Grade \>=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (\>) 42 days from the point of detection in a normal bone marrow (less than \[\<\] 500 per microliter \[/uL\] or platelet count \<10,000/uL, or hemoglobin \<8 gram per deciliter \[g/dL\] with \<5% blasts and no evidence of disease or dysplasia), 3) inability to deliver \>= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. |
| Secondary | Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) | An AE was any untoward medical occurrence in a participant. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported. |
| Secondary | Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | Screening up to maximum of 537 days | Participants with systolic blood pressure (BP) less than (\<) 90 millimeters of mercury (mmHg), maximum increase and decrease from baseline systolic BP of more than or equal to (\>=) 30 mmHg, diastolic BP \<50 mmHg, maximum increase and decrease from baseline diastolic BP \>=20 mmHg, and a heart rate of more than (\>) 120 beats per minute (bpm) at any time post dose were summarized. |
| Secondary | Number of Participants With Laboratory Test Abnormalities | Screening to EOT (maximum duration: 537 days) | Number of participants with laboratory test abnormalities without regard to baseline abnormality as per the pre defined criteria were reported. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). |
| Secondary | Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21 | Baseline, Cycle 1 Day 21 | Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
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 First Cycle Dose-limiting Toxicities (DLTs) | Cycle 1 Day 1 to end of Cycle 1 (28 days) | Only participants who did not have major treatment deviations in Cycle 1 were evaluable for DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade | Baseline up to 28 days post last dose of study medication (maximum duration: 537 days) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | Screening up to maximum of 537 days | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities | Screening to EOT (maximum duration: 537 days) | The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21 | Baseline, Cycle 1 Day 21 | The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of PF-04449913 and had at least 1 PD parameter in at least 1 treatment period. Results were not collected and reported for the other reporting arms since none of the participants in those arms had evaluable PD samples. | ratio | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) | The pharmacokinetic (PK) analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in | Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6) | The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. | hours | MEDIAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21 | Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21 | PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm. | hours | MEDIAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group463
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 First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 5 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 10 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 20 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 40 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 80 mg | 1 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 120 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 180 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 270 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 400 mg | 0 | Participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | PF-04449913 600 mg | 1 | Participants |
1 to 10 of 463Source ClinicalTrials.gov
See all 463 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-04449913 5 mg | 3 | |
| Overall Study | STARTED | PF-04449913 10 mg | 3 | |
| Overall Study | STARTED | PF-04449913 20 mg | 4 | |
| Overall Study | STARTED | PF-04449913 40 mg | 4 | |
| Overall Study | STARTED | PF-04449913 80 mg | 8 | |
| Overall Study | STARTED | PF-04449913 120 mg | 3 | |
| Overall Study | STARTED | PF-04449913 180 mg | 3 | |
| Overall Study | STARTED | PF-04449913 270 mg | 5 | |
| Overall Study | STARTED | PF-04449913 400 mg | 9 | |
| Overall Study | STARTED | PF-04449913 600 mg | 5 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2,870
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-04449913 5 mg | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 10 mg | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 20 mg | 3 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 40 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 80 mg | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 120 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 180 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 270 mg | 1 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 400 mg | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04449913 600 mg | 2 | 5 |
1 to 10 of 2,870Source ClinicalTrials.gov
See all 2,870 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-04449913 5 mg | ||
| Total, all-cause mortality | PF-04449913 10 mg | ||
| Total, all-cause mortality | PF-04449913 20 mg | ||
| Total, all-cause mortality | PF-04449913 40 mg | ||
| Total, all-cause mortality | PF-04449913 80 mg | ||
| Total, all-cause mortality | PF-04449913 120 mg | ||
| Total, all-cause mortality | PF-04449913 180 mg | ||
| Total, all-cause mortality | PF-04449913 270 mg | ||
| Total, all-cause mortality | PF-04449913 400 mg | ||
| Total, all-cause mortality | PF-04449913 600 mg |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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.
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