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NCT01065844 · ClinicalTrials.gov registry record · Phase 2

Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

A Phase 2 study, sponsored by University of Iowa.

Completed
Registry status
Phase 2
Development phase
15
Enrollment target

NCT01065844: Completed Phase 2 study, sponsored by University of Iowa.

NCT01065844 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01065844, a Phase 2 study, has completed, sponsored by University of Iowa.

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck. Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking this medication. Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page questionnaire. Subjects would also be evaluated clinically by the oncologist to determine if the NFV was having an anti-neoplastic effect. The study remains unfunded. Therefore, potential subjects must be willing to provide self-travel to study site. This study requires a screening visit, initial study visit, and monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.

Primary Outcome

Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Interventions

  • DRUG Nelfinavir

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2009-10
Est. Completion 2017-11
Phase Phase 2
University of Iowa

228 total trials

What the finished NCT01065844 record still lists

NCT01065844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

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

NCT01065844 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01065844 about?

NCT01065844 is a clinical study titled "Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck". The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck. Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking th...

What is the current status of trial NCT01065844?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2009-10. Estimated completion is 2017-11.

What interventions are being tested in trial NCT01065844?

The interventions under investigation include: Nelfinavir (DRUG).

Who is sponsoring clinical trial NCT01065844?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01065844's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 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 NCT01065844, the US trial registry maintained by the National Library of Medicine. NCT01065844 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.