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Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

APX001 with Standard of Care anti-fungal agent

About this trial

This is an interventional other trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Provision of written consent
Ages 18-75 inclusive, male or female
Diagnosis of Acute Myeloid Leukemia
Patients entering first induction treatment chemotherapy
Expected to be neutropenic (<500 ANC/ul) for >/= 10 days

Key Exclusion Criteria:

Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months
Current fever (> 38 degrees Celsius)
Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine

Sites / Locations

University of Cologne, Center for Integrated Oncology (CIO)
Johannes Gutenberg, University of Mainz
University of Munich, Grosshadern Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APX001 with Standard of Care Anti-fungal agent

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC)

Peak Plasma Concentration (Cmax)

Full Information

NCT ID

NCT03333005

First Posted

October 23, 2017

Last Updated

June 6, 2022

Sponsor

Pfizer

Collaborators

The Clinical Trials Centre Cologne

1. Study Identification

Unique Protocol Identification Number

NCT03333005

Brief Title

Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

Official Title

An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 27, 2017 (Actual)

Primary Completion Date

October 26, 2018 (Actual)

Study Completion Date

October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

The Clinical Trials Centre Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia. A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing. All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis. APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

APX001 with Standard of Care Anti-fungal agent

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

APX001 with Standard of Care anti-fungal agent

Intervention Description

safety assessment

Primary Outcome Measure Information:

Title

Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0

Time Frame

One to forty-four days

Secondary Outcome Measure Information:

Title

Area under the plasma concentration versus time curve (AUC)

Time Frame

One to forty-four days

Title

Peak Plasma Concentration (Cmax)

Time Frame

One to forty-four days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Provision of written consent Ages 18-75 inclusive, male or female Diagnosis of Acute Myeloid Leukemia Patients entering first induction treatment chemotherapy Expected to be neutropenic (<500 ANC/ul) for >/= 10 days Key Exclusion Criteria: Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months Current fever (> 38 degrees Celsius) Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University of Cologne, Center for Integrated Oncology (CIO)

City

Cologne

ZIP/Postal Code

50931

Country

Germany

Facility Name

Johannes Gutenberg, University of Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

University of Munich, Grosshadern Campus

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

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