Phase I Study of Intravenous Artesunate for Solid Tumors | NCT02353026

Studies
Phase I Study of Intravenous Artesunate for Solid Tumors

NCT02353026

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

Intravenous Artesunate

Countries

United States

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

Nov 2016

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

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 27, 2015

First Submission Date that Met QC Criteria

Jan 27, 2015

First Posted Date

Feb 2, 2015Estimated

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

Nov 17, 2016

Last Update Posted Date

Nov 18, 2016Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity.

Detailed Description

A rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade >/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. If the toxicity was grade 2, then enrollment will continue on that dose level. If the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. Dose escalation with the 3+3 design will continue until >/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. Then, the maximum tolerated dose and recommended Phase II dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred.

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous Artesunate	Experimental	Intravenous Artesunate administered on Day 1 and 8 every 3 weeks	Drug: Intravenous Artesunate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Artesunate	Drug	Intravenous Artesunate in escalating doses: 8, 12, 18, 25, 34, 45 mg/kg on days 1 and 8 of every 3 week cycles	Intravenous Artesunate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose	One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least one measurable lesion by RECIST criteria
Willing to undergo pharmacogenetic testing
Over the age of 18 years and able to provide informed consent
No standard of care therapy available which has a proven overall survival benefit
Adequate kidney, liver, and bone marrow function
Life expectancy of greater than 3 months
ECOG performance status less than or equal to 2

Exclusion Criteria:

Chemotherapy or surgery within 4 weeks of treatment start
Radiation treatment within 3 weeks prior to treatment start
Untreated brain metastases or neurologically unstable CNS metastases
Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John F Deeken, MD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown Lombardi Comprehensive Cancer Center		Washington D.C.	District of Columbia	20007	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29392450	Derived	Deeken JF, Wang H, Hartley M, Cheema AK, Smaglo B, Hwang JJ, He AR, Weiner LM, Marshall JL, Giaccone G, Liu S, Luecht J, Spiegel JY, Pishvaian MJ. A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Mar;81(3):587-596. doi: 10.1007/s00280-018-3533-8. Epub 2018 Feb 1.