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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 is a Phase 1 study that was terminated before completion, run by Aptevo Therapeutics. The registered enrollment target is 87 participants.

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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

FieldValue
Enrollment Target 87 participants
Start Date 2012-09
Est. Completion 2021-04-21
Phase Phase 1

Sponsor

Aptevo Therapeutics

6 total trials

What the Registry Record Tells You About NCT01644253

The ClinicalTrials.gov registry entry for NCT01644253 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aptevo Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which 20 mg/kg TRU-016 + Rituximab is the first listed.

NCT01644253 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.