CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 174 enrolled
Drug / intervention
PF-04518600 +3 moredrug
Likely dose
PF-04518600 0.01 mg/kgfrom 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/NCT02315066
NCT02315066Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS

Pfizer·interventional·Posted Dec 11, 2014·Updated Apr 21, 2022

In Brief

A Phase 1 clinical trial evaluating PF-04518600 and PF-04518600 plus PF-05082566 for Neoplasms. Completed, enrolled 174 participants across 30 sites in 4 countries.

Detailed Summary

To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesFrance, Japan, Netherlands, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 11, 2014
Enrollment StartApr 23, 2015
Primary CompletionNov 12, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 11.6 years ago

Interventions

PF-04518600drug

Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined

PF-04518600drug

Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously

PF-04518600 plus PF-05082566drug

Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.

PF-04518600 plus PF-05082566drug

Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.