Clinical Trial Details

NCT ID: NCT02954653
Date Last Changed: September 28, 2017

Overview

Research Study Summary

A clinical research study for the treatment of Acute Myeloid Leukemia

Research Study Title

A Phase 1 Dose Escalation Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of Intravenous Pf-06747143, Administered As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

Purpose

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.

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Recruitment Details

Phase
1
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Pfizer
Duration
42 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

Part 1 and Part 2 cohort 3: Patients diagnosed with AML ( bone marrow (BM) or peripheral blood (PB) blast counts > /= 20%) and have received prior chemotherapy and/or standard of care and have relapsed, refractory or Minimal Residual Disease (defined as patients showing residual blast 10-14 days post-induction chemotherapy).

• Patients that are not candidates to receive standard of care and/or refusing the standard care of therapies will also be considered.

Part 2 - Cohort 1 and 2: Newly diagnosed, previously untreated de novo or secondary AML population (AML with bone marrow or peripheral blast counts 20%):

  • Cohort 1: Fit to receive intensive remission induction chemotherapy.

  • Cohort 2: Unfit to receive or not considered a candidate for intensive remission induction chemotherapy.

Part 1 and 2:

  • Life expectancy at least 12 weeks.

  • Hydroxyurea is allowed on study to control total peripheral white blood cell count but must be ceased 24 hours prior to first dose.

  • Off of prior therapy for 2-4 weeks prior to first dose.

  • ECOG performance status: 0 to 2.

  • Resolved acute effects of any prior therapy.

  • Adequate renal and hepatic function.

Exclusion Criteria:

  • Patients with acute promyelocytic leukemia, AML with known central nervous system (CNS) involvement unless the patient has completed treatment for the CNS disease, has recovered from the acute effects of therapy prior to study entry, and is neurologically stable.

  • Patient is known refractory to platelet or packed red cell transfusions per institutional guidelines.

  • Prior treatment with a compound targeting CXCR4.

  • Chronic systemic corticosteroid treatment.

  • Known or suspected hypersensitivity to recombinant human proteins.

  • Chronic graft versus host disease (GVHD), active GVHD with other than Grade 1 skin involvement, or GVHD requiring systemic immunosuppressive treatment (Part 1 and cohort 3).

  • Not recovered from stem cell transplant associated toxicities (Part 1 and cohort 3).

  • Prior treatment with hypomethylating agents or chemotherapy for antecedent myelodysplastic syndrome (MDS) (Part 2, cohort 2)

  • AML associated with favorable risk karyotypes, including inv(16), t(8;21), t(16;16), or t(15;17) (cohort 2)

  • Candidates for allogeneic stem cell transplant (Part 2, cohort 2)

  • Known hypersensitivity to cytarabine or daunorubicin (Part 2, cohort 1) and decitabine or azacitidine or mannitol (Part 2, cohort 2).

Site Locations (4)

Country State City Zip Facility and Contact
United States Arizona Tucson 85719 The University of Arizona Cancer Center-North Campus
United States Arizona Tucson 85724 Banner-University Medical Center Tucson
United States Illinois Chicago 60637 The University of Chicago Medical Center
United States North Carolina Winston-Salem 27157 Wake Forest Baptist Health

Contact

Pfizer CT.gov Call Center
1-800-718-1021
E-mail:

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