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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02954653
First Posted: November 3, 2016
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
September 21, 2016
November 3, 2016
November 30, 2017
November 28, 2016
October 31, 2017   (Final data collection date for primary outcome measure)
  • Number of patients with dose limiting toxicity [ Time Frame: Up to 28 days ]
  • Objective response rate (Part 2) [ Time Frame: up to 16 weeks ]
  • Duration of objective response rate (Part 2) [ Time Frame: up to 16 weeks ]
  • Progression free survival (Part 2) [ Time Frame: up to 16 weeks ]
Same as current
Complete list of historical versions of study NCT02954653 on ClinicalTrials.gov Archive Site
  • Maximum observed plasma concentrations [ Time Frame: Day 1: 0, 1; 24, 48, 96 hours; Day 8: 0; Day 15: 0, 1 hr; Day 22: 0; Cycle 2: Day 1: 0, 1, 24, 48, 95 hours; Day 8, 15 and 22 and Day 1 of all additional cycles ]
  • Incidence of anti-drug antibodies (ADA) [ Time Frame: Day 1, predose; Day 15, predose; Day 1 of Cycles 2-6 predose then every other cycle Day 1 predose ]
  • Frequency and characterization of adverse events according to CTCAE v4.03 [ Time Frame: weekly up to study completion (approximately 12 months) ]
    Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE v4.03), timing, seriousness, and relationship to study therapy
  • Objective response rate (Part 1) [ Time Frame: up to 16 weeks ]
  • Duration of objective response rate (Part 1) [ Time Frame: up to 16 weeks ]
  • Progression free survival (Part 1) [ Time Frame: up to 16 weeks ]
Same as current
Not Provided
Not Provided
 
A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia
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
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.
Patients will receive intravenous (IV) PF-06747143 as a weekly infusion (QW) in 28 day cycles at escalating doses. The proposed dosing scheme includes 0.3, 1.0, 3.0, 10, 15, and 20 mg/kg. Patients will be monitored for dose limiting toxicity (DLT) in the dose escalation in order to define the MTD. Two of the three arms in the dose expansion will include PF-06747143 in combination with standard of care chemotherapy and will include a safety lead in. The third arm, pending clinical data, will be PF-06747143 as a single agent.
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • 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
  • Experimental: Dose Escalation
    Single agent PF-06747143 dose escalation
    Intervention: Biological: PF-06747143
  • Active Comparator: Cohort 1
    PF-06747143 with standard dose cytarabine and daunorubicin.
    Interventions:
    • Biological: PF-06747143
    • Drug: Cytarabine
    • Drug: Daunorubicin
  • Active Comparator: Cohort 2
    PF-06747143 in combination with Azacitidine or Decitabine.
    Interventions:
    • Biological: PF-06747143
    • Drug: Azacitidine
    • Drug: Decitabine
  • Experimental: Cohort 3
    PF-06747143 dose expansion as a single agent.
    Intervention: Biological: PF-06747143
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
October 31, 2017
October 31, 2017   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02954653
B7861002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP