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NCT00623870 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.
A Phase 1 study of Hematologic Neoplasms, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 11
- Study locations
NCT00623870 is a Phase 1 study of Hematologic Neoplasms that has completed, run by Hoffmann-La Roche. The registered enrollment target is 116 participants, below the 1,021-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (89% lower). The trial reports 11 study locations across 9 states.
The verdict
NCT00623870, a Phase 1 study of Hematologic Neoplasms, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 11
- Study locations
Study Summary
This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.
Conditions Studied
Interventions
- DRUG RO5045337
Study Locations (11)
Other
- - Glasgow
- - Leeds
- - Oxford
California
- - Duarte
New Jersey
- - New Brunswick
New York
- - New York
Texas
- - Houston
Ontario
- - Toronto
Quebec
- - Montreal
Emilia-Romagna
- - Bologna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00623870
The ClinicalTrials.gov registry entry for NCT00623870 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,021-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (89% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which RO5045337 is the first listed.
NCT00623870 reports 11 study locations spanning 9 distinct geographic areas - top geographies include Other, California, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00623870 about?
NCT00623870 is a clinical study titled "A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.". This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 d...
What is the current status of trial NCT00623870?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2008-05. Estimated completion is 2012-11.
What conditions does trial NCT00623870 study?
This clinical trial studies the following conditions: Hematologic Neoplasms.
What interventions are being tested in trial NCT00623870?
The interventions under investigation include: RO5045337 (DRUG).
Who is sponsoring clinical trial NCT00623870?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00623870 being conducted?
This trial has 11 study locations across California, New Jersey, New York, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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