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

NCT01214616 | Completed Phase 1 Results

• 1 other identifier: 1200.84
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• AUCτ,ss for Afatinib

  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")

• Cmax,ss for Afatinib

  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")

• AUC0-∞ for Vinorelbine

  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")

• Cmax for Vinorelbine

  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")

• Objective Tumour Response

  Pre-treatment, every 8 weeks after start of study treatment, end of treatment

Study Arms (1)

afatinib and vinorelbine IV

EXPERIMENTAL

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

Drug: afatinib 20mg; Drug: afatinib 40mg; Drug: vinorelbine IV 25 or 20mg/m2

Interventions

afatinib 20mg DRUG

patient to receive afatinib low dose po daily in combination with vinorelbine iv

afatinib and vinorelbine IV

afatinib 40mg DRUG

patient to receive afatinib high dose po daily in combination with vinorelbine iv

afatinib and vinorelbine IV

vinorelbine IV 25 or 20mg/m2 DRUG

patient to receive standard dose vinorelbine once a week for four times per cycle

afatinib and vinorelbine IV

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
• Prior treatment with afatinib and or vinorelbine
• Clinically significant active infectious disease

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

1200.84.003 Boehringer Ingelheim Investigational Site

Chuo-ku, Osaka, Osaka, Japan

Location

1200.84.004 Boehringer Ingelheim Investigational Site

Kashiwa, Chiba, Japan

Location

1200.84.001 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1200.84.002 Boehringer Ingelheim Investigational Site

Sakyo-ku, Kyoto, Kyoto, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

MTD was not determined and below Cohort 2 due to DLTs likely related to vinorelbine. After the revised dose criteria for afatinib and vinorelbine were implemented, Cohort 3 was established as a recommended dose.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 7, 2025
• Results First Posted: July 22, 2014

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)