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NCT01108666 · ClinicalTrials.gov registry record · Phase 2

Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)

A Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.

Terminated
Registry status
Phase 2
Development phase
7
Enrollment target

NCT01108666: Clinical Trial Phase 2 study, sponsored by Abramson Cancer Center at Penn Medicine.

NCT01108666 is a Phase 2 study that was terminated before completion, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01108666, a Phase 2 study, was terminated before completion, sponsored by Abramson Cancer Center at Penn Medicine.

TERMINATED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

Seventy two patients are being asked to take part in this research study because they have been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is being done to determine the highest safe dose of proton beam radiotherapy and/or study drug (called Nelfinavir) that can be given with concurrent chemoradiotherapy to patients with cancer without causing bad side effects; and to develop biomarker for clinical outcome. This study will be done in two phases. In the first phase, feasibility will be established. We will follow patients treatment courses and record side effects at the standard proton radiation dose that can be given together with Cisplatinum + Etoposide or Carboplatin + Paclitaxel. In the second phase, we will see if it is possible to increase the total proton radiation dose or study drug without increasing the number of bad side effects while treated together with chemotherapy drugs.

Primary Outcome

Ability to successfully plan proton plans

Interventions

  • DRUG Nelfinavir

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-03
Est. Completion 2018-12
Phase Phase 2

Why NCT01108666 stopped before completion

NCT01108666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Nelfinavir is the first listed.

NCT01108666 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01108666 about?

NCT01108666 is a clinical study titled "Proton Beam Radiation With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III Non Small Cell Lung Cancer (NSCLC)". Seventy two patients are being asked to take part in this research study because they have been diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC). This study is being done to determine the highest safe dose of proton beam radiotherapy and/or study drug (called Nelfinavir) that can...

What is the current status of trial NCT01108666?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2010-03. Estimated completion is 2018-12.

What interventions are being tested in trial NCT01108666?

The interventions under investigation include: Nelfinavir (DRUG).

Who is sponsoring clinical trial NCT01108666?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01108666's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 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 NCT01108666, the US trial registry maintained by the National Library of Medicine. NCT01108666 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.