CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 147 enrolled
Drug / intervention
PF-06801591 +1 moredrug
Likely dose
PF-06801591 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02573259
NCT02573259Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-06801591 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA, SQUAMOUS CELL HEAD AND NECK CANCER, OVARIAN CANCER, SARCOMA, NON-SMALL CELL LUNG CANCER, UROTHELIAL CARCINOMA OR OTHER SOLID TUMORS.

Pfizer·interventional·Posted Oct 9, 2015·Updated Dec 13, 2021

In Brief

A Phase 1 clinical trial evaluating PF-06801591 for Part 1 and 8 related conditions. Completed, enrolled 147 participants across 67 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPart 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
CountriesBulgaria, Malaysia, Poland, Russia, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartFeb 10, 2016
Primary CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.7 years ago

Interventions

PF-06801591drug

IV every 21 days (Part 1)

PF-06801591drug

300 mg SC every 28 days (Part 1 and 2)