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NCT02023905 · ClinicalTrials.gov registry record · Phase 2

Everolimus With and Without Temozolomide in Adult Low Grade Glioma

A Phase 2 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 2
Development phase
27
Enrollment target

NCT02023905: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.

NCT02023905 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02023905, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001, also known as Afinitor®) alone or with temozolomide has on the patient and the patient's low-grade glioma. Everolimus is being investigated as an anticancer agent based on its potential to prevent tumor cells from growing and multiplying. Specifically, there is a protein called mTOR that we think helps many tumors to grow, and everolimus blocks the effect of mTOR. Temozolomide is also an anticancer agent that prevents tumor cells from growing and multiplying.

Primary Outcome

Participants will be analyzed based on intention to treat using the Response Assessment in Neuro-Oncology (RANO) criteria for progression. Based on RANO criteria, a responder is defined using both radiographic and clinical criteria. Complete response (CR) or Partial Response (PR) will be first assessed by radiographic changes as determined by an improvement of the bi-dimensional evaluation of the tumor size. In addition, changes in neurologic function and steroid use will be considered. Analyses

Interventions

  • DRUG Temozolomide
  • DRUG Everolimus

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2014-03-19
Est. Completion 2021-09-30
Phase Phase 2

Why NCT02023905 stopped before completion

NCT02023905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.

NCT02023905 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02023905 about?

NCT02023905 is a clinical study titled "Everolimus With and Without Temozolomide in Adult Low Grade Glioma". The purpose of this study is to find out what effects, good and/or bad, everolimus (RAD001, also known as Afinitor®) alone or with temozolomide has on the patient and the patient's low-grade glioma. Everolimus is being investigated as an anticancer agent based on its potential to prevent tumor cells...

What is the current status of trial NCT02023905?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2014-03-19. Estimated completion is 2021-09-30.

What interventions are being tested in trial NCT02023905?

The interventions under investigation include: Temozolomide (DRUG), Everolimus (DRUG).

Who is sponsoring clinical trial NCT02023905?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02023905's enrollment target sits among peer trials

27 1697th of 2000 higher than 293 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 NCT02023905, the US trial registry maintained by the National Library of Medicine. NCT02023905 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.