Trial · NCT00557856
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
NCT00557856, Phase 1, Completed, Pfizer; results first posted 2015-08-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors. Trials, record NCT00557856. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00557856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
- NCT number
- NCT00557856
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 70 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Advanced Solid Tumors
- Interventions
- PF-03446962
- First posted
- 2007-11-14
- Last updated
- 2015-10-19
- Other registries' IDs
- eudract:2007-001422-27
- Results first posted
- 2015-08-13
- Limitations and caveats
- Results for tumor vascular function adopting dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) was not reported as per change in planned analysis.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs). |
| Primary | Recommended Phase 2 Dose (RP2D): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | RP2D was defined as the lower dose level to MTD based on the safety profile. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). 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. Non-SAE included all AE minus SAE. Treatment-emergent events 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. |
| Secondary | Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Total time from onset of adverse event till the event is resolved. Treatment-emergent events 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. |
| Secondary | Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Laboratory tests included hematology (hemoglobin, lymphocytes absolute \[abs\], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute \[NCI\] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 \[mild AE: did not cause any significant problem, no dose adjustment required\]; grade 2 \[moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event\]; grade 3 \[severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event\] and grade 4 \[life threatening AE\]). Overall data of the 4 grades is reported. |
| Secondary | Percentage of Participants With Objective Response: Part 1 and Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as \>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. |
| Secondary | Percentage of Participants With Disease Control: Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: \>=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase. |
| Secondary | Time To Progression (TTP): Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\] per RECIST). PD: \>=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | milligram/kilogram (mg/kg) | NUMBER |
| PRIMARY | Recommended Phase 2 Dose (RP2D): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | mg/kg | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned. | ||
| SECONDARY | Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response: Part 1 and Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control: Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Time To Progression (TTP): Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Safety population included all participants who received at least one dose of study drug. | months | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD): Part 1 | PF-03446962 | 10.0 | milligram/kilogram (mg/kg) | ||
| Recommended Phase 2 Dose (RP2D): Part 1 | PF-03446962 | 7.0 | mg/kg | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 0.5 mg/kg: Part 1 | All causalities | 5 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 1 mg/kg | All causalities | 5 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 2 mg/kg : Part 1 | All causalities | 6 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 3 mg/kg: Part 1 | All causalities | 3 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 4.5 mg/kg: Part 1 | All causalities | 4 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 6.75 mg/kg: Part 1 | All causalities | 8 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 10 mg/kg: Part 1 | All causalities | 7 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | PF-03446962 15 mg/kg: Part 1 | All causalities | 6 | participants |
1 to 10 of 1,210Source ClinicalTrials.gov
See all 1,210 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 0.5 mg/kg: Part 1 | 7 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 1 mg/kg: Part 1 | 5 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 2 mg/kg : Part 1 | 6 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 3 mg/kg: Part 1 | 3 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 4.5 mg/kg: Part 1 | 4 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 6.75 mg/kg: Part 1 | 8 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 10 mg/kg: Part 1 | 7 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 15 mg/kg: Part 1 | 6 | |
| Part 1: Dose Escalation Phase | STARTED | PF-03446962 7 mg/kg: Part 2 | 0 | |
| Part 1: Dose Escalation Phase | Treated | PF-03446962 0.5 mg/kg: Part 1 | 5 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events204
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-03446962 | 5 | 68 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-03446962 | 1 | 68 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-03446962 | 2 | 68 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PF-03446962 | 10 | 68 | |
| other | Vertigo | Ear and labyrinth disorders | PF-03446962 | 1 | 68 | |
| other | Conjunctival haemorrhage | Eye disorders | PF-03446962 | 1 | 68 | |
| other | Eye discharge | Eye disorders | PF-03446962 | 1 | 68 | |
| other | Eye pain | Eye disorders | PF-03446962 | 1 | 68 | |
| other | Eyelid oedema | Eye disorders | PF-03446962 | 2 | 68 | |
| other | Abdominal distension | Gastrointestinal disorders | PF-03446962 | 2 | 68 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03446962 | ||
| Total, other adverse events | PF-03446962 | 68 | 68 |
| Total, serious adverse events | PF-03446962 | 24 | 68 |
Source ClinicalTrials.gov
Papers2
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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