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

Neoplasms Clinical Trial

Official title:

An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214616
• Other study ID #: 1200.84
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2010
• Last updated: June 24, 2014
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion criteria:

• Histologically confirmed diagnosis of malignancy that is advanced and for which standard therapies do not exist or are no longer effective.

• Life expectancy at least 12 weeks

• Eastern Cooperative Oncology Group Performance Status 0 or 1

• Adequate hepatic, renal, haematologic and other organ function

• Written informed consent

Exclusion criteria:

• Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks

• Prior treatment with afatinib and or vinorelbine

• Clinically significant active infectious disease

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• afatinib 20mg
patient to receive afatinib low dose po daily in combination with vinorelbine iv
• afatinib 40mg
patient to receive afatinib high dose po daily in combination with vinorelbine iv
• vinorelbine IV 25 or 20mg/m2
patient to receive standard dose vinorelbine once a week for four times per cycle

Locations

Country	Name	City	State
Japan	1200.84.003 Boehringer Ingelheim Investigational Site	Chuo-ku, Osaka, Osaka
Japan	1200.84.004 Boehringer Ingelheim Investigational Site	Kashiwa, Chiba
Japan	1200.84.001 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1200.84.002 Boehringer Ingelheim Investigational Site	Sakyo-ku, Kyoto, Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course	DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)	during 1st course	No
Primary	Drug-related Adverse Events	Number of patients with drug-related adverse events	during the treatment period or up to 28 days after the completion of drug administration, up to 730 days	No
Secondary	AUCt,ss for Afatinib	area under the plasma concentration-time curve following dose at steady state over the dosing interval t	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")	No
Secondary	Cmax,ss for Afatinib	maximum measured plasma concentration at steady state	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")	No
Secondary	AUC0-8 for Vinorelbine	area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity	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")	No
Secondary	Cmax for Vinorelbine	maximum measured blood concentration	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")	No
Secondary	Objective Tumour Response	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."	Pre-treatment, every 8 weeks after start of study treatment, end of treatment	No

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