CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
BGJ398 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02257541
NCT02257541Phase 2Completed

A Phase Ib/II Study of BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

Memorial Sloan Kettering Cancer Center·interventional·Posted Oct 6, 2014·Updated Mar 30, 2020

In Brief

A Phase 2 clinical trial evaluating BGJ398 and Imatinib Mesylate for Advanced Gastrointestinal Stromal Tumor (GIST). Completed, enrolled 16 participants across 7 sites.

Detailed Summary

The goal of a phase Ib clinical trial is to find the doses of drugs that are safe. Although BGJ398 has been given to patients safely on its own, it has never been given together with imatinib mesylate. In this study, we will test the safety of taking BGJ398 with imatinib mesylate. The investigators will learn this by closely checking for side effects that the patient may experience. Side effects can be seen in laboratory studies, on physical examination, or by asking the patient.Once a dose has been determined to be safe, a larger Phase II study will be done in patients with advanced GIST who have never received any prior treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 6, 2014
Enrollment StartOct 2, 2014
Primary CompletionMar 25, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.7 years ago

Interventions

BGJ398drug

Imatinib Mesylatedrug