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NCT01813734 · ClinicalTrials.gov registry record · Phase 2

Ponatinib in Advanced NSCLC w/ RET Translocations

A Phase 2 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
9
Enrollment target

NCT01813734: Completed Phase 2 study, sponsored by Massachusetts General Hospital.

NCT01813734 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01813734, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
9 participants
Enrollment target

Study Summary

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It has been found that some people with NSCLC have a change (mutation) in a certain gene called the RET gene. This mutated gene may help cancer cells grow. Only participants with a RET mutation will be allowed to participate. In this study, investigators are testing the strategy of using a study drug designed to inhibit or shut off growth signals that results from the mutated RET gene. Ponatinib is an anti-cancer drug that has been used in research studies for other types of cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this research study, investigators are looking to see whether ponatinib is effective and safe in treating NSCLC harboring RET rearrangements.

Primary Outcome

The number of participants that achieved either a partial or complete response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Interventions

  • DRUG Ponatinib

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2013-09
Est. Completion 2018-08
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT01813734 record still lists

NCT01813734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).

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

NCT01813734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01813734 about?

NCT01813734 is a clinical study titled "Ponatinib in Advanced NSCLC w/ RET Translocations". This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It has been found that some people with NSCLC have a change (m...

What is the current status of trial NCT01813734?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2013-09. Estimated completion is 2018-08.

What interventions are being tested in trial NCT01813734?

The interventions under investigation include: Ponatinib (DRUG).

Who is sponsoring clinical trial NCT01813734?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01813734's enrollment target sits among peer trials

9 1989th of 2000 higher than 11 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 NCT01813734, the US trial registry maintained by the National Library of Medicine. NCT01813734 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.