Safety and Pharmacokinetics of Intravenous and Oral APX00... | NCT03333005

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

NCT03333005

Sponsor

Basilea Pharmaceutica

Status

Completed

Last Update Posted

May 17, 2024Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Acute Myeloid Leukemia

Interventions

APX001 with Standard of Care anti-fungal agent

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2017Actual

Primary Completion Date

Oct 26, 2018Actual

Completion Date

Oct 26, 2018Actual

First Submitted Date

Oct 23, 2017

First Submission Date that Met QC Criteria

Nov 2, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2024

Last Update Posted Date

May 17, 2024Actual

Name	Class
The Clinical Trials Centre Cologne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APX001 with Standard of Care Anti-fungal agent	Experimental		Drug: APX001 with Standard of Care anti-fungal agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
APX001 with Standard of Care anti-fungal agent	Drug	safety assessment	APX001 with Standard of Care Anti-fungal agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0		One to forty-four days

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC)		One to forty-four days
Peak Plasma Concentration (Cmax)		One to forty-four days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Engelhardt	Basilea Pharmaceutica International Ltd, Allschwil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne, Center for Integrated Oncology (CIO)		Cologne		50931	Germany
Johannes Gutenberg, University of Mainz

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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