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

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ClinicalTrials.gov Identifier: NCT01214616
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: afatinib 20mg Drug: afatinib 40mg Drug: vinorelbine IV 25 or 20mg/m2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: afatinib and vinorelbine IV
patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV
 Drug: afatinib 20mg
patient to receive afatinib low dose po daily in combination with vinorelbine iv

Drug: afatinib 40mg
patient to receive afatinib high dose po daily in combination with vinorelbine iv

Drug: vinorelbine IV 25 or 20mg/m2
patient to receive standard dose vinorelbine once a week for four times per cycle


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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."


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214616


Locations
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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, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01214616    
Other Study ID Numbers: 1200.84
First Posted: October 5, 2010    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Vinorelbine
Afatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors