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NCT01202370 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) Given on Days 1, 4 8, 12 & 15 of an Every 21-day Cycle in Adult Patients With Refractory or Metastatic Solid Malignancies
A Phase 1 study of Solid Malignancies, sponsored by University of Kentucky.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT01202370 is a Phase 1 study of Solid Malignancies that has completed, run by University of Kentucky. The registered enrollment target is 3 participants, below the 104-participant average among 3 other Solid Malignancies trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01202370, a Phase 1 study of Solid Malignancies, has completed, sponsored by University of Kentucky.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents, inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation cogeners are hampered by a labile α-hydroxy-δ-lactone pharmacophore, which hydrolyzes to yield the inactive carboxylate form of the drug. AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) is a third generation analog engineered to be stable in blood and highly potent. Its enhanced stability results from two factors: (1) AR-67 is highly lipophilic, partitioning into lipid bilayers, thus protecting it from hydrolysis in the aqueous milieu of the bloodstream, and (2) the 10-hydroxy functionality of the drug effectively ablates the high affinity interactions of the carboxylate drug form with albumin, which has been previously shown to diminish the levels of the active lactone species in the circulation. In a recently completed phase I trial, AR-67 showed over 85% lactone stability at all time points studied, and was well-tolerated with grade 4 thrombocytopenia, neutropenic fever and grade 3 fatigue as dose limiting toxicities. The MTD was established at 7.5 mg/m2/day in a daily times five of a 21 day cycle. Preclinical data indicates that AR-67 may concentrate in tumors for a prolonged period of time, compared to plasma clearance of the drug, a phenomenon which has the potential to improve efficacy and decrease toxicity of this compound. What is not known is the optimal dose and schedule of AR-67 needed to produce high tumor penetration, and modest systemic exposure. This pilot proposal seeks to study AR-67 in a novel dosing schedule and to evaluate the feasibility of performing tumor biopsies to determine the tumor half-life of AR-67 in humans. By using multiple tumor biopsies, as a means to document penetration of tumor tissue by AR-67, and compare that to plasma clearance of the drug, the investigator
Conditions Studied
Interventions
- DRUG 7-t-butyldimethylsilyl-10-hydroxycamptothecin
Study Locations (1)
Kentucky
- Markey Cancer Center, University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202370
The ClinicalTrials.gov registry entry for NCT01202370 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 3 other Solid Malignancies trials with a reported enrollment target (97% lower). The listed sponsor is University of Kentucky, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Malignancies appearing as the primary indexed condition, and to 1 intervention - of which 7-t-butyldimethylsilyl-10-hydroxycamptothecin is the first listed.
NCT01202370 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT01202370 about?
NCT01202370 is a clinical study titled "A Phase I Study of AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) Given on Days 1, 4 8, 12 & 15 of an Every 21-day Cycle in Adult Patients With Refractory or Metastatic Solid Malignancies". Camptothecins are a potent class of anticancer drugs that inhibit DNA Topoisomerase I. While seen strictly as cytotoxic compounds, camptothecins are actually also targeted agents, inhibiting DNA-Topoisomerase I (Topo I) cleavable complex. First and second generation cogeners are hampered by a labile...
What is the current status of trial NCT01202370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2010-09. Estimated completion is 2011-07.
What conditions does trial NCT01202370 study?
This clinical trial studies the following conditions: Solid Malignancies.
What interventions are being tested in trial NCT01202370?
The interventions under investigation include: 7-t-butyldimethylsilyl-10-hydroxycamptothecin (DRUG).
Who is sponsoring clinical trial NCT01202370?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202370 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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