Clinical trial · Interventional
Phase I Study of Intravenous Artesunate for Solid Tumors
A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Artesunate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous Artesunate
- description
- Intravenous Artesunate administered on Day 1 and 8 every 3 weeks
- interventionNames
- Drug: Intravenous Artesunate
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 1 year
- description
- One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDeeken 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