A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01307267 |
Recruitment Status :
Completed
First Posted : March 2, 2011
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
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 |
Drug: PF-05082566 Drug: rituximab |
Enrollment | 190 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | There was 1 participant who was enrolled but withdrew the consent before starting any of the treatment arms; therefore, this participant was not included in the participant flow table. |
Arm/Group Title | Portion A: PF-05082566 0.006mg/kg | Portion A: PF-05082566 0.03mg/kg | Portion A: PF-05082566 0.06mg/kg | Portion A: PF-05082566 0.12mg/kg | Portion A: PF-05082566 0.18mg/kg | Portion A: PF-05082566 0.24mg/kg | Portion A: PF-05082566 0.3mg/kg | Portion A: PF-05082566 0.6mg/kg | Portion A: PF-05082566 1.2mg/kg | Portion A: PF-05082566 2.4mg/kg | Portion A: PF-05082566 5mg/kg | Portion A: PF-05082566 10mg/kg | Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2 |
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Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. |
Period Title: Overall Study | |||||||||||||||||||||||
Started | 4 | 3 | 6 | 4 | 3 | 42 | 3 | 4 | 31 | 5 | 6 | 11 | 3 | 3 | 4 | 3 | 3 | 3 | 4 | 32 | 3 | 5 | 4 |
Completed | 0 | 0 | 1 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 3 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 |
Not Completed | 4 | 3 | 5 | 3 | 1 | 41 | 2 | 4 | 30 | 5 | 6 | 11 | 1 | 0 | 2 | 1 | 1 | 1 | 2 | 32 | 3 | 5 | 4 |
Reason Not Completed | |||||||||||||||||||||||
Death | 4 | 3 | 5 | 3 | 1 | 26 | 2 | 2 | 21 | 2 | 3 | 9 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 8 | 1 | 2 | 2 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 5 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
Other | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 1 | 3 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 19 | 2 | 3 | 2 |
Baseline Characteristics
Arm/Group Title | Portion A: PF-05082566 0.006mg/kg | Portion A: PF-05082566 0.03mg/kg | Portion A: PF-05082566 0.06mg/kg | Portion A: PF-05082566 0.12mg/kg | Portion A: PF-05082566 0.18mg/kg | Portion A: PF-05082566 0.24mg/kg | Portion A: PF-05082566 0.3mg/kg | Portion A: PF-05082566 0.6mg/kg | Portion A: PF-05082566 1.2mg/kg | Portion A: PF-05082566 2.4mg/kg | Portion A: PF-05082566 5mg/kg | Portion A: PF-05082566 10mg/kg | Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2 | Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2 | Total | |
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Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter [mg/m^2] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier. | Total of all reporting groups | |
Overall Number of Baseline Participants | 4 | 3 | 6 | 4 | 3 | 42 | 3 | 4 | 31 | 5 | 6 | 11 | 3 | 3 | 4 | 3 | 3 | 3 | 4 | 32 | 3 | 5 | 4 | 189 | |
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All participants who received at least 1 dose of PF-05082566 or rituximab.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||||||||||||||||
Number Analyzed | 4 participants | 3 participants | 6 participants | 4 participants | 3 participants | 42 participants | 3 participants | 4 participants | 31 participants | 5 participants | 6 participants | 11 participants | 3 participants | 3 participants | 4 participants | 3 participants | 3 participants | 3 participants | 4 participants | 32 participants | 3 participants | 5 participants | 4 participants | 189 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
3 75.0%
|
2 66.7%
|
4 66.7%
|
3 75.0%
|
1 33.3%
|
17 40.5%
|
1 33.3%
|
2 50.0%
|
19 61.3%
|
4 80.0%
|
3 50.0%
|
5 45.5%
|
3 100.0%
|
2 66.7%
|
4 100.0%
|
0 0.0%
|
2 66.7%
|
3 100.0%
|
2 50.0%
|
14 43.8%
|
0 0.0%
|
3 60.0%
|
3 75.0%
|
100 52.9%
|
|
>=65 years |
1 25.0%
|
1 33.3%
|
2 33.3%
|
1 25.0%
|
2 66.7%
|
25 59.5%
|
2 66.7%
|
2 50.0%
|
12 38.7%
|
1 20.0%
|
3 50.0%
|
6 54.5%
|
0 0.0%
|
1 33.3%
|
0 0.0%
|
3 100.0%
|
1 33.3%
|
0 0.0%
|
2 50.0%
|
18 56.3%
|
3 100.0%
|
2 40.0%
|
1 25.0%
|
89 47.1%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 6 participants | 4 participants | 3 participants | 42 participants | 3 participants | 4 participants | 31 participants | 5 participants | 6 participants | 11 participants | 3 participants | 3 participants | 4 participants | 3 participants | 3 participants | 3 participants | 4 participants | 32 participants | 3 participants | 5 participants | 4 participants | 189 participants | |
Female |
0 0.0%
|
1 33.3%
|
2 33.3%
|
2 50.0%
|
2 66.7%
|
15 35.7%
|
0 0.0%
|
1 25.0%
|
13 41.9%
|
3 60.0%
|
1 16.7%
|
3 27.3%
|
2 66.7%
|
1 33.3%
|
2 50.0%
|
1 33.3%
|
2 66.7%
|
1 33.3%
|
1 25.0%
|
15 46.9%
|
1 33.3%
|
2 40.0%
|
1 25.0%
|
72 38.1%
|
|
Male |
4 100.0%
|
2 66.7%
|
4 66.7%
|
2 50.0%
|
1 33.3%
|
27 64.3%
|
3 100.0%
|
3 75.0%
|
18 58.1%
|
2 40.0%
|
5 83.3%
|
8 72.7%
|
1 33.3%
|
2 66.7%
|
2 50.0%
|
2 66.7%
|
1 33.3%
|
2 66.7%
|
3 75.0%
|
17 53.1%
|
2 66.7%
|
3 60.0%
|
3 75.0%
|
117 61.9%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 6 participants | 4 participants | 3 participants | 42 participants | 3 participants | 4 participants | 31 participants | 5 participants | 6 participants | 11 participants | 3 participants | 3 participants | 4 participants | 3 participants | 3 participants | 3 participants | 4 participants | 32 participants | 3 participants | 5 participants | 4 participants | 189 participants | |
White |
3 75.0%
|
3 100.0%
|
3 50.0%
|
4 100.0%
|
2 66.7%
|
36 85.7%
|
1 33.3%
|
4 100.0%
|
24 77.4%
|
4 80.0%
|
2 33.3%
|
4 36.4%
|
2 66.7%
|
3 100.0%
|
3 75.0%
|
2 66.7%
|
2 66.7%
|
2 66.7%
|
4 100.0%
|
22 68.8%
|
2 66.7%
|
5 100.0%
|
4 100.0%
|
141 74.6%
|
|
Black |
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
0 0.0%
|
1 2.4%
|
1 33.3%
|
0 0.0%
|
1 3.2%
|
1 20.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 33.3%
|
0 0.0%
|
0 0.0%
|
1 33.3%
|
0 0.0%
|
0 0.0%
|
7 3.7%
|
|
Asian |
1 25.0%
|
0 0.0%
|
2 33.3%
|
0 0.0%
|
0 0.0%
|
1 2.4%
|
0 0.0%
|
0 0.0%
|
2 6.5%
|
0 0.0%
|
3 50.0%
|
7 63.6%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
6 18.8%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
22 11.6%
|
|
Other |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 33.3%
|
4 9.5%
|
0 0.0%
|
0 0.0%
|
4 12.9%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
1 33.3%
|
0 0.0%
|
1 25.0%
|
1 33.3%
|
1 33.3%
|
0 0.0%
|
0 0.0%
|
4 12.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
18 9.5%
|
|
Unspecified |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 33.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.5%
|