CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
BI-6727 +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/NCT00969761
NCT00969761Phase 1Completed
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A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors

Boehringer Ingelheim·interventional·Posted Sep 1, 2009·Updated Jan 31, 2019

In Brief

A Phase 1 clinical trial evaluating BI-6727 and BI 6727 for Neoplasms. Completed, enrolled 61 participants across 2 sites.

Detailed Summary

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin). Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.8 years ago

Interventions

BI-6727drug

Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

BI 6727drug

low to high dose