CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
BIBW 2992 +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/NCT00993499
NCT00993499Phase 1Completed
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A Phase Ib Open Label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Sirolimus in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

Boehringer Ingelheim·interventional·Posted Oct 12, 2009·Updated Oct 7, 2015

In Brief

A Phase 1 clinical trial evaluating BIBW 2992 and Sirolimus (rapamycin) for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 44 participants across 8 sites.

Detailed Summary

The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus. The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles. Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesSpain
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.7 years ago

Interventions

BIBW 2992drug

Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs

Sirolimus (rapamycin)drug

Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.