Phase I Study of Intravenous Artesunate for Solid Tumors

NCT02353026 | Completed Phase 1 DMC

• 1 other identifier: Pro028
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities

  1 year

Study Arms (1)

Intravenous Artesunate

EXPERIMENTAL

Intravenous Artesunate administered on Day 1 and 8 every 3 weeks

Drug: Intravenous Artesunate

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• 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.

  PMID: 29392450 DERIVED

Study Officials

• John F Deeken, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

US (1)