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NCT01243346 · ClinicalTrials.gov registry record · Phase 2

Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene

A Phase 2 study of D842-related Mutant GIST, sponsored by Arog Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT01243346: Completed Phase 2 study of D842-related Mutant GIST, sponsored by Arog Pharmaceuticals.

NCT01243346 is a Phase 2 study of D842-related Mutant GIST that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01243346, a Phase 2 study of D842-related Mutant GIST, has completed, sponsored by Arog Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.

Primary Outcome

To determine the response rate of patients with advanced D842V mutant GIST, when treated with Crenolanib (CP-868,596). Response will primarily be determined by RECIST criteria

Conditions Studied

Interventions

  • DRUG Crenolanib besylate (CP-868,596-26), Dose: 140mg BID

Study Locations (2)

Oregon

  • Knight Cancer Institute, Oregon Health and Science University - Portland

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-04
Est. Completion 2014-07
Phase Phase 2
Arog Pharmaceuticals

13 total trials

What the finished NCT01243346 record still lists

NCT01243346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 1 condition, with D842-related Mutant GIST appearing as the primary indexed condition, and to 1 intervention - of which Crenolanib besylate (CP-868,596-26), Dose: 140mg BID is the first listed.

NCT01243346 reports a single indexed study location in Oregon, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01243346 about?

NCT01243346 is a clinical study titled "Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene". This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.

What is the current status of trial NCT01243346?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-04. Estimated completion is 2014-07.

What conditions does trial NCT01243346 study?

This clinical trial studies the following conditions: D842-related Mutant GIST.

What interventions are being tested in trial NCT01243346?

The interventions under investigation include: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID (DRUG).

Who is sponsoring clinical trial NCT01243346?

This trial is sponsored by Arog Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01243346 being conducted?

This trial has 2 study locations across Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01243346's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 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 NCT01243346, the US trial registry maintained by the National Library of Medicine. NCT01243346 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.