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Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors
NCT00942799 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase I, open-label, multicenter, dose-escalation study designed to assess the safety and tolerability of Genz-644282, administered as an intravenous (IV) infusion, to patients with advanced malignant solid tumors. Each 28 day cycle of treatment will consist of 3 consecutive weeks of treatment every 28 days(i.e., treatment will be administered on Days 1, 8, and 15 every 28 days). Each 21 day cycle of treatment will consist of 2 consecutive weeks of treatment every 21 days(i.e., treatment will be administered on Days 1 and 8 every 21 days). Treatment with Genz-644282 will continue until disease progression or unacceptable toxicity is observed. Approximately 110 patients will be enrolled in this study. Patients will be enrolled in escalating dose cohorts until the Maximum Tolerated Doses (MTDs) for the 2 dosing schedules are established. To further evaluate safety, approximately 40 additional patients with advanced malignant solid tumors will be enrolled and treated at the MTDs (20 for each dosing schedule) during an expansion phase.
Conditions Studied
Interventions
- DRUG Genz-644282 (28-day dosing schedule)
- DRUG Genz-644282 (21-day dosing schedule)
Study Locations (4)
Arizona
- TGen Clinical Research Services at Scottsdale Healthcare — Scottsdale
Florida
- Moffitt Cancer Center — Tampa
Michigan
- Wayne State University, Division of Hematology/Oncology, Karmanos Cancer Institute — Detroit
New Jersey
- Cancer Institute of New Jersey — New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00942799
The ClinicalTrials.gov registry entry for NCT00942799 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 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 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 Solid Tumors appearing as the primary indexed condition, and to 2 interventions — of which Genz-644282 (28-day dosing schedule) 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: NCT00942799 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Arizona, Florida, Michigan. 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 NCT00942799 about?
NCT00942799 is a clinical study titled "Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors". This is a Phase I, open-label, multicenter, dose-escalation study designed to assess the safety and tolerability of Genz-644282, administered as an intravenous (IV) infusion, to patients with advanced malignant solid tumors. Each 28 day cycle of treatment will consist of 3 consecutive weeks of treat...
What is the current status of trial NCT00942799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2009-07. Estimated completion is 2013-01.
What conditions does trial NCT00942799 study?
This clinical trial studies the following conditions: Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00942799?
The interventions under investigation include: Genz-644282 (28-day dosing schedule) (DRUG), Genz-644282 (21-day dosing schedule) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00942799?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00942799 being conducted?
This trial has 4 study locations across Arizona, Florida, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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