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NCT01644253 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Safety and Efficacy Study of TRU-016
A Phase 1 study, sponsored by Aptevo Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT01644253: Clinical Trial Phase 1 study, sponsored by Aptevo Therapeutics.
NCT01644253 is a Phase 1 study that was terminated before completion, run by Aptevo Therapeutics. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644253, a Phase 1 study, was terminated before completion, sponsored by Aptevo Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.
Interventions
- BIOLOGICAL 20 mg/kg TRU-016 + Rituximab
- BIOLOGICAL 10 mg/kg TRU-016 + Rituximab
- BIOLOGICAL TRU-016 20 mg/kg + Obinutuzumab
- BIOLOGICAL TRU-016 6-20 mg/kg + idelalisib + rituximab
- BIOLOGICAL TRU-016 10-20 mg/kg + ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2012-09 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 1 |
Why NCT01644253 stopped before completion
NCT01644253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 5 interventions - of which 20 mg/kg TRU-016 + Rituximab is the first listed.
NCT01644253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01644253 about?
NCT01644253 is a clinical study titled "Phase 1b Safety and Efficacy Study of TRU-016". The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL...
What is the current status of trial NCT01644253?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2012-09. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT01644253?
The interventions under investigation include: 20 mg/kg TRU-016 + Rituximab (BIOLOGICAL), 10 mg/kg TRU-016 + Rituximab (BIOLOGICAL), TRU-016 20 mg/kg + Obinutuzumab (BIOLOGICAL), TRU-016 6-20 mg/kg + idelalisib + rituximab (BIOLOGICAL), TRU-016 10-20 mg/kg + ibrutinib (BIOLOGICAL).
Who is sponsoring clinical trial NCT01644253?
This trial is sponsored by Aptevo Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644253's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 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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