NeoplasmsPhase 1NCT01214616

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

A Phase 1 study testing afatinib 20mg, afatinib 40mg and vinorelbine IV 25 or 20mg/m2 in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Neoplasms
What is being tested?: afatinib 20mg, afatinib 40mg and vinorelbine IV 25 or 20mg/m2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 4 sitesJapan
Study dates: 1 Oct 2010to 1 May 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

1200.84.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Osaka, Osaka
1200.84.004 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba
1200.84.001 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1200.84.002 Boehringer Ingelheim Investigational Site
Sakyo-ku, Kyoto, Kyoto

Other trials in Japan

About this study

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

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
Being tested: afatinib 20mg, afatinib 40mg, vinorelbine IV 25 or 20mg/m2
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

afatinib 20mgDrug
patient to receive afatinib low dose po daily in combination with vinorelbine iv
afatinib 40mgDrug
patient to receive afatinib high dose po daily in combination with vinorelbine iv
vinorelbine IV 25 or 20mg/m2Drug
patient to receive standard dose vinorelbine once a week for four times per cycle

Study groups in NCT01214616
Study group	Role	What they receive
afatinib and vinorelbine IV	Experimental	patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV Receives: Drug: afatinib 20mg; Drug: afatinib 40mg; Drug: vinorelbine IV 25 or 20mg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: during 1st course
Drug-related Adverse Events
Number of patients with drug-related adverse events
Measured: 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
area under the plasma concentration-time curve following dose at steady state over the dosing interval τ
Measured: 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
maximum measured plasma concentration at steady state
Measured: 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
area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity
Measured: 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
maximum measured blood concentration
Measured: 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
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."
Measured: Pre-treatment, every 8 weeks after start of study treatment, end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20101 May 2013

First posted5 Oct 2010 (estimated)
Study start1 Oct 2010
Primary completion1 May 2013
Study completion1 May 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214616
Sponsor's protocol ID: 1200.84
Status last verified: Jan 2025
First submitted: 4 Oct 2010
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01214616
Acronym / sponsor ID: 1200.84
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Oct 2010 (actual)
Primary completion: 1 May 2013 (actual)
Study completion: 1 May 2013 (actual)
First posted: 5 Oct 2010 (estimated)
Results: Posted 22 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
afatinib and vinorelbine IV	Experimental	Drug: afatinib 20mg, Drug: afatinib 40mg, Drug: vinorelbine IV 25 or 20mg/m2patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
afatinib 20mgpatient to receive afatinib low dose po daily in combination with vinorelbine iv	Drug	afatinib and vinorelbine IV
afatinib 40mgpatient to receive afatinib high dose po daily in combination with vinorelbine iv	Drug	afatinib and vinorelbine IV
vinorelbine IV 25 or 20mg/m2patient to receive standard dose vinorelbine once a week for four times per cycle	Drug	afatinib and vinorelbine IV

Primary outcome

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)
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

5 secondary outcomes

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")
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")
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")
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")
Objective Tumour Response
Time frame: Pre-treatment, every 8 weeks after start of study treatment, end of treatment

Results and safety

Results posted to the registry on 22 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)	3	0
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)	5	0
Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)	3	0
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)	6	0

Primary outcome: Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course

Time frame: during 1st course. Number. Unit: participants

Measure	Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1) n = 3	Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2) n = 5	Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) n = 3	Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) n = 6
Value	0	3	0	1

Population analysed: Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine)

Primary outcome: 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. Unit: participants

Measure	Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1) n = 3	Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2) n = 5	Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) n = 3	Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) n = 6
Value	3	5	3	6

Population analysed: Treated set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: during the treatment period or up to 28 days after the completion of drug administration, up to 730 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)	4 of 5 (80%)	5 of 5 (100%)	Not reported
Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)	0 of 3 (0%)	3 of 3 (100%)	Not reported
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing afatinib 20mg, afatinib 40mg and vinorelbine IV 25 or 20mg/m2 in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course (time frame: during 1st course). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01214616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.