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NCT02573259 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 147
- Enrollment target
NCT02573259: Completed Phase 1 study, sponsored by Pfizer.
NCT02573259 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 147 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02573259, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 147 participants
- Enrollment target
Study Summary
Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.
Primary Outcome
DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE
Interventions
- DRUG PF-06801591
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2016-02-10 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 1 |
What the finished NCT02573259 record still lists
NCT02573259 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-06801591 is the first listed.
NCT02573259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02573259 about?
NCT02573259 is a clinical study titled "A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors". Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, ...
What is the current status of trial NCT02573259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 147 participants. The study started on 2016-02-10. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT02573259?
The interventions under investigation include: PF-06801591 (DRUG).
Who is sponsoring clinical trial NCT02573259?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02573259's enrollment target sits among peer trials
147 387th of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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