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NCT01691807 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma
A Phase 1 study of Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT01691807: Completed Phase 1 study of Cancer, sponsored by Novartis Pharmaceuticals.
NCT01691807 is a Phase 1 study of Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691807, a Phase 1 study of Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL).
Primary Outcome
The amount of ofatumumab and bendamustine in the blood will be measured when given individually or together to obtain Cmax and Area Under the Curve. Bendamustine levels will be collected at Cycles 1 and 2: Predose, 0.25, 0.5, 0.75, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours. Ofatumumab will be collected at Cycle 4: Predose, end of infusion, then 1, 2, 24, and 72 hours after end of infusion, then once each on Days 8, 15, and 22.
Conditions Studied
Interventions
- DRUG bendamustine
- DRUG ofatumumab
Study Locations (5)
Texas
- Novartis Investigative Site - Houston
- Novartis Investigative Site - San Antonio
Alabama
- Novartis Investigative Site - Birmingham
Mississippi
- Novartis Investigative Site - Southaven
West Virginia
- Novartis Investigative Site - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01691807 record still lists
NCT01691807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which bendamustine is the first listed.
NCT01691807 lists 5 locations in 4 states (Texas, Alabama, Mississippi).
Frequently Asked Questions
What is clinical trial NCT01691807 about?
NCT01691807 is a clinical study titled "Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma". The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL).
What is the current status of trial NCT01691807?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-01. Estimated completion is 2015-12.
What conditions does trial NCT01691807 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT01691807?
The interventions under investigation include: bendamustine (DRUG), ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01691807?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01691807 being conducted?
This trial has 5 study locations across Alabama, Mississippi, Texas, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01691807's enrollment target sits among peer trials
30 502nd of 615 higher than 93 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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