MedTrace Logo

A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

NCT02954653 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-21

Study results available
· View outcomes & findings →

Summary

Two part, dose escalation and dose expansion study. Open label, multi center, non randomized, multiple dose, safety, pharmacokinetic and pharmacodynamic study of single agent PF-06747143 in sequential dose levels of adult patients with refractory or relapsed AML in order to establish maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) or maximally permitted dose (MPD) following by a 3 arm dose expansion with PF-06747143 in combination with standard of care chemotherapy in adult patients with AML.

Conditions

Interventions

BIOLOGICAL

PF-06747143

PF 06747143 is a humanized IgG1 monoclonal antibody (mAb) that is an antagonist of CXCR4.

DRUG

Cytarabine

100-200 mg/m2 continuous infusion for 7 days)

DRUG

Daunorubicin

60-90 mg/m2 daily for 3 days

DRUG

Azacitidine

75 mg/m2 sub-cutaneous or intravenous for 7 days)

DRUG

Decitabine

20 mg/m2 continuous intravenous infusion for 5 days in a 4-week schedule

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2017-12-05
Completion
2017-12-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954653 on ClinicalTrials.gov