CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 90 enrolled
Drug / intervention
BI 860585 +4 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/NCT01938846
NCT01938846Phase 1Completed
CompareCT.gov

An Open Label Phase I Dose Finding Study of BI 860585 Administered Orally in a Continuous Dosing Schedule as Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumours

Boehringer Ingelheim·interventional·Posted Sep 10, 2013·Updated Jan 4, 2019

In Brief

A Phase 1 clinical trial evaluating BI 860585, exemestane, and 1 other intervention for Neoplasms. Completed, enrolled 90 participants across 4 sites in 2 countries.

Detailed Summary

The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI 860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs, patients are entered sequentially into escalating dose cohorts. Secondary objectives are objective response and disease control according to RECIST criteria version 1.1

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesBelgium, Italy
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartSep 5, 2013
Primary CompletionJul 30, 2016
Study CompletionJun 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.8 years ago

Interventions

BI 860585drug

BI 860585 multiple dose escalation, once daily

exemestanedrug

exemestane once daily

BI 860585drug

BI 860585 multiple dose escalation, once daily

BI 860585drug

BI 860585 multiple dose escalation, once daily

paclitaxeldrug

paclitaxel once weekly