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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 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.

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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

Solid Tumors

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

FieldValue
Enrollment Target 87 participants
Start Date 2009-07
Est. Completion 2013-01
Phase Phase 1

Sponsor

Genzyme, a Sanofi Company

196 total trials

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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, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (69% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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