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NCT01307267 · ClinicalTrials.gov registry record · Phase 1
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
A Phase 1 study of Carcinoma, Non-Small Cell Lung and Lymphoma, Non-Hodgkin, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT01307267: Completed Phase 1 study of Carcinoma, Non-Small Cell Lung and Lymphoma, Non-Hodgkin, sponsored by Pfizer.
NCT01307267 is a Phase 1 study of Carcinoma, Non-Small Cell Lung and Lymphoma, Non-Hodgkin that has completed, run by Pfizer. The registered enrollment target is 190 participants, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307267, a Phase 1 study of Carcinoma, Non-Small Cell Lung and Lymphoma, Non-Hodgkin, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).
Primary Outcome
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 tr
Conditions Studied
Interventions
- DRUG rituximab
- DRUG PF-05082566
Study Locations (20)
California
- City of Hope - Duarte
- UC San Diego Moores Cancer Center-Investigational Drug Services - La Jolla
- UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital) - La Jolla
- UC San Diego Moores Cancer Center - La Jolla
- Research Administration Office: Clinical Research Unit - Los Angeles
- Ronald Reagan UCLA Medical Center, Drug Information Center - Los Angeles
- UCLA Bowyer Clinic - Los Angeles
- UCLA Hematology-Oncology Clinic - Los Angeles
- Stanford University Medical Center - Palo Alto
- Stanford University Medical Center - Palo Alto
- UC San Diego Medical Center - Hillcrest - San Diego
- Santa Monica UCLA Hematology & Oncology Clinic - Santa Monica
- Stanford University Medical Center - Stanford
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital - Atlanta
- The Emory Clinic, Building A - Atlanta
- The Emory Clinic - Atlanta
- Winship Cancer Institute - Atlanta
District of Columbia
- Georgetown University Medical Center Department of Pharmacy, Research - Washington D.C.
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2019-02-20 |
| Phase | Phase 1 |
What the finished NCT01307267 record still lists
NCT01307267 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 322-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (41% lower).
The record links to 7 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which rituximab is the first listed.
NCT01307267 names 20 study sites across 3 states, led by California, Georgia, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01307267 about?
NCT01307267 is a clinical study titled "A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab". A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).
What is the current status of trial NCT01307267?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2011-06-21. Estimated completion is 2019-02-20.
What conditions does trial NCT01307267 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Malignant Melanoma, Lymphoma, Large B-Cell, Diffuse.
What interventions are being tested in trial NCT01307267?
The interventions under investigation include: rituximab (DRUG), PF-05082566 (DRUG).
Who is sponsoring clinical trial NCT01307267?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01307267 being conducted?
This trial has 20 study locations across California, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01307267's enrollment target sits among peer trials
190 51st of 130 higher than 79 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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