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NCT00086528 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
A Phase 1 study of Cancer, sponsored by Kadmon Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT00086528 is a Phase 1 study of Cancer that has completed, run by Kadmon Corporation. The registered enrollment target is 41 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00086528, a Phase 1 study of Cancer, has completed, sponsored by Kadmon Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The secondary objectives of this study are as follows: * To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors, * To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors. The exploratory objective of this study is as follows: * To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells. In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study: * Long-term safety and tolerability of XL647 after repeat administration, * Tumor response after repeat administration of XL647.
Conditions Studied
Interventions
- DRUG XL647
Study Locations (2)
California
- Stanford University Medical Center - Stanford
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086528
The ClinicalTrials.gov registry entry for NCT00086528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Kadmon Corporation, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which XL647 is the first listed.
NCT00086528 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00086528 about?
NCT00086528 is a clinical study titled "Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors". The primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The secondary objectives of this study are as follows: * To evaluate the plasma pharmacokinetics of XL647 a...
What is the current status of trial NCT00086528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2004-06. Estimated completion is 2007-11.
What conditions does trial NCT00086528 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT00086528?
The interventions under investigation include: XL647 (DRUG).
Who is sponsoring clinical trial NCT00086528?
This trial is sponsored by Kadmon Corporation, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00086528 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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