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Completed

NCT Number: NCT01214616

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

* 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.

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Key information

Conditions

Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1200.84.003 Boehringer Ingelheim Investigational Site, Chuo-ku, Osaka, Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course

    Time frame: during 1st course

    DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)

  2. Drug-related Adverse Events

    Time frame: 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 outcomes

  1. AUCτ,ss for Afatinib

    Time frame: 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

  2. Cmax,ss for Afatinib

    Time frame: 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

  3. AUC0-∞ for Vinorelbine

    Time frame: 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

  4. Cmax for Vinorelbine

    Time frame: 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

  5. Objective Tumour Response

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2010
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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