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NCT02630043 · ClinicalTrials.gov registry record · Phase 1

Trial of Tolcapone With Oxaliplatin for Neuroblastoma

A Phase 1 study, sponsored by Giselle Sholler.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT02630043: Clinical Trial Phase 1 study, sponsored by Giselle Sholler.

NCT02630043 is a Phase 1 study that was terminated before completion, run by Giselle Sholler. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02630043, a Phase 1 study, was terminated before completion, sponsored by Giselle Sholler.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is approved by the U.S. Food and Drug Administration (FDA) for adults, but is an investigational drug in this study because it has not been approved in pediatrics for this indication. Oxaliplatin, although a drug approved by the FDA for other cancers, is investigational for treatment of neuroblastoma in this study. This study will look at the safety and tolerability of tolcapone in combination with oxaliplatin as well as the tumors response to this study drug.

Primary Outcome

To determine the safety and tolerability of tolcapone alone and in combination with oxaliplatin at 4 dose levels of tolcapone

Interventions

  • DRUG Oxaliplatin
  • DRUG Tolcapone

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2015-12
Est. Completion 2019-07
Phase Phase 1
Giselle Sholler

20 total trials

Why NCT02630043 stopped before completion

NCT02630043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

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

NCT02630043 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02630043 about?

NCT02630043 is a clinical study titled "Trial of Tolcapone With Oxaliplatin for Neuroblastoma". The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is approved by the U.S. Food and Drug Administration (FDA) for adults, but is an investigational drug in this study be...

What is the current status of trial NCT02630043?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2015-12. Estimated completion is 2019-07.

What interventions are being tested in trial NCT02630043?

The interventions under investigation include: Oxaliplatin (DRUG), Tolcapone (DRUG).

Who is sponsoring clinical trial NCT02630043?

This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02630043's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 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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Source: ClinicalTrials.gov NCT02630043, the US trial registry maintained by the National Library of Medicine. NCT02630043 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.