Trial · NCT01307267
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
NCT01307267, Phase 1, Completed, Pfizer; results first posted 2020-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab. Trials, record NCT01307267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01307267
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
- NCT number
- NCT01307267
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 190 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Squamous Cell of Head and Neck, Malignant Melanoma
- Interventions
- PF-05082566, rituximab, PF-05082566
- First posted
- 2011-03-02
- Last updated
- 2020-03-17
- Other registries' IDs
- eudract:2011-002799-17
- Results first posted
- 2020-03-17
Source ClinicalTrials.gov
Registered outcomes46
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 First 2 Cycles of Portion A | Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days) | DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days. |
| Primary | Number of Participants With DLTs in First 2 Cycles of Portion B | Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days) | DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | Up to approximately 2 years | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator. |
| Secondary | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Up to approximately 2 years | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). |
| Secondary | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Up to approximately 2 years | Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here. |
| Secondary | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Up to approximately 2 years | Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here. |
| Secondary | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | Up to approximately 2 years | For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator. |
| Secondary | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose | Cmax of PF-05082566 was observed directly from data. |
| Secondary | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | Day 1 pre-dose of Cycle 2 | Ctrough of PF-05082566 was observed directly from data. |
| Secondary | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose. | Tmax of PF-05082566 was observed directly from data as time of Cmax. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
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 First 2 Cycles of Portion A | Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days) | All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With DLTs in First 2 Cycles of Portion B | Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days) | All participants who received at least 1 dose of PF-05082566 and 1 dose of rituximab in the first 2 cycles of Portion B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A | Up to approximately 2 years | All participants who received at least 1 dose of PF-05082566 in Portion A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A | Up to approximately 2 years | All participants who received at least 1 dose of PF-05082566 in Portion A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Up to approximately 2 years | All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A | Up to approximately 2 years | Number of Participants Analyzed represents all participants who received at least 1 dose of PF-05082566 in Portion A and had chemistries laboratory test data. Number Analyzed represents all participants who received at least 1 dose of PF-05082566 in Portion A and had data for the specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A | Up to approximately 2 years | All participants who received at least 1 dose of PF-05082566 in Portion A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A | Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose | All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category. | micrograms per milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A | Day 1 pre-dose of Cycle 2 | All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A | Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose. | All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. Number Analyzed represents those participants who had data for each specified category. | hours (hr) | MEDIAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group2,014
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 First 2 Cycles of Portion A | Portion A: PF-05082566 0.006mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.03mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.06mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.12mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.18mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.24mg/kg | 1 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.3mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 0.6mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 1.2mg/kg | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A | Portion A: PF-05082566 2.4mg/kg | 0 | Participants |
1 to 10 of 2,014Source ClinicalTrials.gov
See all 2,014 results by groupParticipant flow69
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Portion A: PF-05082566 0.006mg/kg | 4 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.03mg/kg | 3 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.06mg/kg | 6 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.12mg/kg | 4 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.18mg/kg | 3 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.24mg/kg | 42 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.3mg/kg | 3 | |
| Overall Study | STARTED | Portion A: PF-05082566 0.6mg/kg | 4 | |
| Overall Study | STARTED | Portion A: PF-05082566 1.2mg/kg | 31 | |
| Overall Study | STARTED | Portion A: PF-05082566 2.4mg/kg | 5 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 participant flowAdverse events5,497
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 | Portion A: PF-05082566 0.006mg/kg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.03mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.06mg/kg | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.12mg/kg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.18mg/kg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.24mg/kg | 4 | 42 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.3mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 0.6mg/kg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 1.2mg/kg | 5 | 31 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Portion A: PF-05082566 2.4mg/kg | 0 | 5 | 0 |
1 to 10 of 5,497Source ClinicalTrials.gov
See all 5,497 adverse eventsAdverse event totals69
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Portion A: PF-05082566 0.006mg/kg | 4 | 4 |
| Total, all-cause mortality | Portion A: PF-05082566 0.03mg/kg | 3 | 3 |
| Total, all-cause mortality | Portion A: PF-05082566 0.06mg/kg | 5 | 6 |
| Total, all-cause mortality | Portion A: PF-05082566 0.12mg/kg | 3 | 4 |
| Total, all-cause mortality | Portion A: PF-05082566 0.18mg/kg | 1 | 3 |
| Total, all-cause mortality | Portion A: PF-05082566 0.24mg/kg | 27 | 42 |
| Total, all-cause mortality | Portion A: PF-05082566 0.3mg/kg | 2 | 3 |
| Total, all-cause mortality | Portion A: PF-05082566 0.6mg/kg | 2 | 4 |
| Total, all-cause mortality | Portion A: PF-05082566 1.2mg/kg | 21 | 31 |
| Total, all-cause mortality | Portion A: PF-05082566 2.4mg/kg | 2 | 5 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 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/NCT01307267
GET https://conductscience.org/api/trials/v1/NCT01307267/registered?page=2