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

NCT02954653

Last updated date
Study Location
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia
Official Title  ICMJE 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
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Liu SH, Gu Y, Pascual B, Yan Z, Hallin M, Zhang C, Fan C, Wang W, Lam J, Spilker ME, Yafawi R, Blasi E, Simmons B, Huser N, Ho WH, Lindquist K, Tran TT, Kudaravalli J, Ma JT, Jimenez G, Barman I, Brown C, Chin SM, Costa MJ, Shelton D, Smeal T, Fantin VR, Pernasetti F. A novel CXCR4 antagonist IgG1 antibody (PF-06747143) for the treatment of hematologic malignancies. Blood Adv. 2017 Jun 21;1(15):1088-1100. doi: 10.1182/bloodadvances.2016003921. eCollection 2017 Jun 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
152
Actual Study Completion Date  ICMJE December 5, 2017
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02954653
Other Study ID Numbers  ICMJE B7861002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019

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