CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
BI 3011441drug
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/NCT04742556
NCT04742556Phase 1Completed

A Phase I Open-label Trial of BI 3011441 in Japanese Patients With NRAS/KRAS Mutation Positive Advanced, Unresectable or Metastatic Refractory Solid Tumours

Boehringer Ingelheim·interventional·Posted Feb 8, 2021·Updated Sep 19, 2024

In Brief

A Phase 1 clinical trial evaluating BI 3011441 for Solid Tumors, KRAS Mutation. Completed, enrolled 15 participants across 3 sites.

Detailed Summary

This study is open to Japanese adults with different types of advanced cancer that are positive for NRAS/KRAS mutations. This is a study in people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find the highest dose of BI 3011441 that Japanese people with advanced cancer can tolerate. BI 3011441 is a medicine that may turn off a signal by NRAS/KRAS that makes tumours grow. Participants take BI 3011441 as capsules once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors collect information on any health problems of the participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedFeb 8, 2021
Enrollment StartMar 15, 2021
Primary CompletionOct 13, 2022
Study CompletionOct 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.4 years ago

Interventions

BI 3011441drug

BI 3011441