You are here

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

Last updated on July 31, 2018

FOR MORE INFORMATION
Study Location
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719 United States
Contact
1-800-718-1021
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).

NCT02954653
Pfizer
Terminated
A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Myelodysplastic Syndrome, Acute Myeloid Leukemia
NCT02367456
All Genders
18+
Years
Multiple Sites
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma, Advanced Malignancies Except Leukemia
NCT00585195
All Genders
18+
Years
Multiple Sites
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now