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NCT01363297 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01363297 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 72 participants.
The verdict
NCT01363297, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
Interventions
- DRUG Inotuzumab Ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363297
The ClinicalTrials.gov registry entry for NCT01363297 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inotuzumab Ozogamicin is the first listed.
NCT01363297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01363297 about?
NCT01363297 is a clinical study titled "Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia". The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The...
What is the current status of trial NCT01363297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2011-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01363297?
The interventions under investigation include: Inotuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT01363297?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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