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NCT01827267 · ClinicalTrials.gov registry record · Phase 2

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT01827267 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 62 participants.

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The verdict

NCT01827267, a Phase 2 study, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

Interventions

  • DRUG temsirolimus
  • DRUG neratinib

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2013-07-01
Est. Completion 2017-10-06
Phase Phase 2

Sponsor

Puma Biotechnology

28 total trials

What the Registry Record Tells You About NCT01827267

The ClinicalTrials.gov registry entry for NCT01827267 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.

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

NCT01827267 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01827267 about?

NCT01827267 is a clinical study titled "Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer". This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

What is the current status of trial NCT01827267?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2013-07-01. Estimated completion is 2017-10-06.

What interventions are being tested in trial NCT01827267?

The interventions under investigation include: temsirolimus (DRUG), neratinib (DRUG).

Who is sponsoring clinical trial NCT01827267?

This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.