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Phase I Study of Intravenous Artesunate for Solid Tumors

NCT ID: NCT02353026

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Artesunate

Intravenous Artesunate administered on Day 1 and 8 every 3 weeks

Group Type EXPERIMENTAL

Intravenous Artesunate

Intervention Type DRUG

Intravenous Artesunate in escalating doses: 8, 12, 18, 25, 34, 45 mg/kg on days 1 and 8 of every 3 week cycles

Interventions

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Intravenous Artesunate

Intravenous Artesunate in escalating doses: 8, 12, 18, 25, 34, 45 mg/kg on days 1 and 8 of every 3 week cycles

Intervention Type DRUG

Eligibility Criteria

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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 \</= 6 months prior to study entry
* Previous diagnosis of alpha- or beta-thalassemia
* Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7
* Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment
* Patients unwilling or unable to comply with the protocol, or provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John F Deeken, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29392450 (View on PubMed)

Other Identifiers

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Pro028

Identifier Type: -

Identifier Source: org_study_id