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Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
NCT00086528 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kadmon Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00086528 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00086528?
The interventions under investigation include: XL647 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00086528?
This trial is sponsored by Kadmon Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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