Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BIBW 2992

• Registration Number: NCT00716417
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.

The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Primary Completion: 2010-07
• Status Verified: 2013-08
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-16
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A. BIBW 2992-cisplatin-paclitaxel	BIBW 2992	daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel
B. BIBW 2992-cisplatin-5FU	BIBW 2992	daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)	21 days	Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B	21 days	The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Objective Response	Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)	Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)	0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration	Cmax,ss represents the maximum concentration of afatinib in plasma at steady state

Trial Locations

Locations (3)

1200.37.3202 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1200.37.3201 Boehringer Ingelheim Investigational Site; 🇧🇪 Edegem, Belgium

1200.37.3203 Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium