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

Sponsor
Boehringer Ingelheim
Study ID
NCT01214616
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

* 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.

Key Dates

Start date
Oct 1, 2010
Status verified
Jan 2025
Primary completion
May 1, 2013
Completion
May 1, 2013

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: afatinib and vinorelbine IV
    patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV

Primary Outcome Measure

Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course [ Time Frame: during 1st course ]

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