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NCT02048488 · ClinicalTrials.gov registry record · Phase 1

A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1 study, sponsored by Tesaro.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT02048488 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 72 participants.

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The verdict

NCT02048488, a Phase 1 study, has completed, sponsored by Tesaro.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.

Interventions

  • DRUG TSR-011

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2012-10
Est. Completion 2018-06
Phase Phase 1

Sponsor

Tesaro

26 total trials

What the Registry Record Tells You About NCT02048488

The ClinicalTrials.gov registry entry for NCT02048488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which TSR-011 is the first listed.

NCT02048488 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02048488 about?

NCT02048488 is a clinical study titled "A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas". TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion ...

What is the current status of trial NCT02048488?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2012-10. Estimated completion is 2018-06.

What interventions are being tested in trial NCT02048488?

The interventions under investigation include: TSR-011 (DRUG).

Who is sponsoring clinical trial NCT02048488?

This trial is sponsored by Tesaro, which has 26 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.