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NCT02343406 · ClinicalTrials.gov registry record · Phase 2

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

A Phase 2 study, sponsored by AbbVie.

Completed
Registry status
Phase 2
Development phase
266
Enrollment target

NCT02343406: Completed Phase 2 study, sponsored by AbbVie.

NCT02343406 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 266 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02343406, a Phase 2 study, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 2
Development phase
266 participants
Enrollment target

Study Summary

This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

Primary Outcome

Overall Survival (OS) was defined as time from randomization to death due to any cause, regardless of whether the event occurred on or off study drug (depatuxizumab mafodotin/temozolomide/lomustine).

Interventions

  • DRUG Temozolomide
  • DRUG Lomustine
  • DRUG Depatuxizumab mafodotin

Trial Details

FieldValue
Enrollment Target 266 participants
Start Date 2015-02-17
Est. Completion 2019-06-24
Phase Phase 2
AbbVie

526 total trials

What the finished NCT02343406 record still lists

NCT02343406 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher).

The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.

NCT02343406 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02343406 about?

NCT02343406 is a clinical study titled "Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas". This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinet...

What is the current status of trial NCT02343406?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 266 participants. The study started on 2015-02-17. Estimated completion is 2019-06-24.

What interventions are being tested in trial NCT02343406?

The interventions under investigation include: Temozolomide (DRUG), Lomustine (DRUG), Depatuxizumab mafodotin (DRUG).

Who is sponsoring clinical trial NCT02343406?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02343406's enrollment target sits among peer trials

266 209th of 2000 higher than 1,791 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02343406, the US trial registry maintained by the National Library of Medicine. NCT02343406 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.