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NCT00299494 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT00299494: Completed Phase 1 study, sponsored by Pfizer.
NCT00299494 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299494, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.
Primary Outcome
Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, gre
Interventions
- DRUG Rituximab
- DRUG inotuzumab ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2006-05-04 |
| Est. Completion | 2014-06-02 |
| Phase | Phase 1 |
What the finished NCT00299494 record still lists
NCT00299494 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00299494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00299494 about?
NCT00299494 is a clinical study titled "Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)". The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or m...
What is the current status of trial NCT00299494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2006-05-04. Estimated completion is 2014-06-02.
What interventions are being tested in trial NCT00299494?
The interventions under investigation include: Rituximab (DRUG), inotuzumab ozogamicin (DRUG).
Who is sponsoring clinical trial NCT00299494?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00299494's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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