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NCT00942799 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors
A Phase 1 study of Solid Tumors, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
- 4
- Study locations
NCT00942799: Completed Phase 1 study of Solid Tumors, sponsored by Genzyme, a Sanofi Company.
NCT00942799 is a Phase 1 study of Solid Tumors that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 87 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (69% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00942799, a Phase 1 study of Solid Tumors, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
- 4
- Study locations
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 |
What the finished NCT00942799 record still lists
NCT00942799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (69% lower).
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.
NCT00942799 reports a single indexed study location in Arizona, Florida, Michigan.
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.
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).
Who is sponsoring clinical trial NCT00942799?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00942799's enrollment target sits among peer trials
87 57th of 125 higher than 69 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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