CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
BI 836845drug
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/NCT01403974
NCT01403974Phase 1Completed
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A Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Patients With Advanced Solid Cancers With Repeated Administrations in Patients Showing Clinical Benefit

Boehringer Ingelheim·interventional·Posted Jul 27, 2011·Updated Jul 25, 2025

In Brief

A Phase 1 clinical trial evaluating BI 836845 for Neoplasms. Completed, enrolled 61 participants across 3 sites.

Detailed Summary

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients. The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesTaiwan
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2011
Enrollment StartJul 19, 2011
Primary CompletionJul 8, 2015
Study CompletionDec 23, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.9 years ago

Interventions

BI 836845drug

Intravenous infusion once every week