Phase I Study of Intravenous Artesunate for Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/19/2016 |
| Start Date: | January 2015 |
| End Date: | December 2015 |
A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors
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.
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.
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.
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.
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 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
We found this trial at
1
site
Click here to add this to my saved trials
