CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
BI 6727 + BIBW 2992drug
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/NCT01206816
NCT01206816Phase 1Completed
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An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBW 2992 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Boehringer Ingelheim·interventional·Posted Sep 22, 2010·Updated Feb 1, 2019

In Brief

A Phase 1 clinical trial evaluating BI 6727 + BIBW 2992 for Neoplasms. Completed, enrolled 57 participants across 3 sites.

Detailed Summary

The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined. Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2010
Enrollment StartOct 4, 2010
Primary CompletionNov 15, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.8 years ago

Interventions

BI 6727 + BIBW 2992drug

BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day