Clinical trial NCT01214616: BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course
timeFrame: during 1st course
measure: Drug-related Adverse Events
timeFrame: during the treatment period or up to 28 days after the completion of drug administration, up to 730 days
Secondary outcomes:
measure: AUCτ,ss for Afatinib
timeFrame: 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")
measure: Cmax,ss for Afatinib
timeFrame: 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")
measure: AUC0-∞ for Vinorelbine
timeFrame: 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")
measure: Cmax for Vinorelbine
timeFrame: 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")
measure: Objective Tumour Response
timeFrame: Pre-treatment, every 8 weeks after start of study treatment, end of treatment
Other outcomes:
Locations:
city: Chuo-ku, Osaka, Osaka
country: Japan
facility: 1200.84.003 Boehringer Ingelheim Investigational Site
city: Kashiwa, Chiba
country: Japan
facility: 1200.84.004 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1200.84.001 Boehringer Ingelheim Investigational Site
city: Sakyo-ku, Kyoto, Kyoto
country: Japan
facility: 1200.84.002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: