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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2017-12-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Single agent PF-06747143 dose escalation

Group Type EXPERIMENTAL

PF-06747143

Intervention Type BIOLOGICAL

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

Cohort 1

PF-06747143 with standard dose cytarabine and daunorubicin.

Group Type ACTIVE_COMPARATOR

PF-06747143

Intervention Type BIOLOGICAL

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

Cytarabine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

60-90 mg/m2 daily for 3 days

Cohort 2

PF-06747143 in combination with Azacitidine or Decitabine.

Group Type ACTIVE_COMPARATOR

PF-06747143

Intervention Type BIOLOGICAL

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

Azacitidine

Intervention Type DRUG

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

Decitabine

Intervention Type DRUG

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

Cohort 3

PF-06747143 dose expansion as a single agent.

Group Type EXPERIMENTAL

PF-06747143

Intervention Type BIOLOGICAL

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

Interventions

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PF-06747143

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

Intervention Type BIOLOGICAL

Cytarabine

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

Intervention Type DRUG

Daunorubicin

60-90 mg/m2 daily for 3 days

Intervention Type DRUG

Azacitidine

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

Intervention Type DRUG

Decitabine

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No