BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: afatinib 20mg; Drug: afatinib 40mg; Drug: vinorelbine IV 25 or 20mg/m2

• Registration Number: NCT01214616
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);

* To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-05-09
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Results First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
afatinib and vinorelbine IV	afatinib 40mg	patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
afatinib and vinorelbine IV	afatinib 20mg	patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
afatinib and vinorelbine IV	vinorelbine IV 25 or 20mg/m2	patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV

Primary Outcome Measures

Name	Time	Method
Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course	during 1st course	DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)
Drug-related Adverse Events	during the treatment period or up to 28 days after the completion of drug administration, up to 730 days	Number of patients with drug-related adverse events

Secondary Outcome Measures

Name	Time	Method
AUCτ,ss for Afatinib	pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine")	area under the plasma concentration-time curve following dose at steady state over the dosing interval τ
Objective Tumour Response	Pre-treatment, every 8 weeks after start of study treatment, end of treatment	According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Cmax for Vinorelbine	predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib")	maximum measured blood concentration
Cmax,ss for Afatinib	pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine")	maximum measured plasma concentration at steady state
AUC0-∞ for Vinorelbine	predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib")	area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (4)

1200.84.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Osaka, Osaka, Japan

1200.84.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Kashiwa, Chiba, Japan

1200.84.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Sakyo-ku, Kyoto, Kyoto, Japan

1200.84.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan