Phase I Study of Intravenous Artesunate for Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353026
• Other study ID #: Pro028
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2015
• Last updated: November 17, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities	1 year	Yes