NeoplasmsPhase 1NCT02020577

Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours

A Phase 1 study testing Cetuximab( erbitux®) and Afatinib in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous histology, recurrent/ metastatic squamous cell… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: Cetuximab( erbitux®) and Afatinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 2 sitesin 2 countries
Study dates: Dec 2013to Apr 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Part A only
Patients must have advanced malignant solid tumours that are metastatic or unresectable
At least one measurable or evaluable (non-measurable) lesion per RECIST 1.1 Part B only
Patients must have:
measurable disease per RECIST 1.1
diagnosis of one of the following

Show all 23Show fewer

Advanced Non-Small Cell Lung Cancer -Squamous Histology (NSCLC-SQ) with no more than 2 lines of chemotherapy for advanced/metastatic disease ( prior EGFR directed treatment is permitted) or
Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck (R/M SCCHN) no more than 2 lines of chemotherapy for advanced disease and no more than 1 line of prior cetuximab permitted.
or
Other malignant solid tumours except sarcomas (for metastatic colorectal cancer, only wild type KRAS are permitted) Part A and B
Age 18 years or older
Written informed consent that is consistent with ICH-GCP guidelines and local law.
Histological/Cytological confirmed diagnosis of malignant solid tumours (exclusion of sarcomas)
Advanced disease for whom standard treatment is ineffective or no longer effective
Recovered from previous therapy related AE to </= Grade 1 at the study entry (except, for stable sensory neuropathy </= Grade 2 and alopecia)
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Adequate organ function as defined by the following criteria:
LVEF >50% or within institutional values
Absolute neutrophil count (ANC) >1500/ mm3
Platelet count >75.000/ mm3
Estimated creatinine clearance > 45ml/ min
Total bilirubin<1.5 times upper limit of institutional normal
Aspartate amino transferase (AST) or alanine amino transferase (ALT) <3 x upper limit of institutional normal (ULN) (if related to liver metastases< 5xULN)

Who cannot join

Chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment.
Hormonal anti-cancer treatment within 2 weeks prior to the start of study treatment (continued use of anti-androgens and/or gonadorelin analogues [LHRH] is permitted)
Radiotherapy within 4 weeks prior to the start of study treatment, except as follows:
Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, and
Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Major surgery (as judged by the investigator) within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study

Show all 23Show fewer

Known hypersensitivity to afatinib or the excipients of any of the trial drugs
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior start treatment.
Female patients of childbearing potential who:
are nursing or
are pregnant or
are not using an acceptable method of birth control or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol.
Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
Requiring treatment with any of the prohibited concomitant medications listed in the protocol that can not be stopped for the duration of trial participation
Known pre-existing interstitial lung disease
Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption)
Active hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment.
Meningeal carcinomatosis
Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment.
Any SPC listed contra-indications for cetuximab
Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

1200.122.33001 Boehringer Ingelheim Investigational Site
Villejuif

Other trials in France

Spain1 site

1200.122.34001 Boehringer Ingelheim Investigational Site
Madrid

Other trials in Spain

About this study

Official title: A Phase Ib Dose Escalation Study of Afatinib in Combination With Cetuximab in Patients With Advanced Solid Tumours

Conditions: Neoplasms
Being tested: Cetuximab( erbitux®), Afatinib
Medical subject headings: Neoplasms

What participants receive

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

Cetuximab( erbitux®)Drug
once per week
AfatinibDrug
once per day

Study groups in NCT02020577
Study group	Role	What they receive
combination arm	Experimental	Patients to receive afatinib once daily plus weekly cetuximab infusion Receives: Drug: Cetuximab( erbitux®); Drug: Afatinib

What is being measured

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

MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).
Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.
Measured: First 21 days treatment cycle
Dose Limiting Toxicities During Cycle 1
Number of Patients With Dose Limiting Toxicity (DLT) Occurring during Cycle 1. The following drug related AEs qualified as DLT:
1. CTCAE Grade ≥2 decrease in cardiac left ventricular function 2) CTCAE Grade 2 diarrhoea lasting for ≥7 days, despite appropriate use of standard antidiarrheal therapy based on Protocol Amendment 1 dated 22 Oct 2013 3) CTCAE Grade ≥3 diarrhoea despite appropriate use of standard anti-diarrheal therapy for at least 2 days. 4) CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days 5) CTCAE Grade ≥3 rash despite standard medical management. 6) CTCAE Grade ≥3 fatigue lasting more than 7 days. 7) All other AEs of CTCAE Grade ≥3 (except alopecia and allergic reaction) that led to an interruption of afatinib and/or cetuximab dosing for more than 14 days until recovery to baseline or Grade 1, whichever was higher. 8) CTCAE Grade 4 hypomagnesemia or Grade 3 hypomagnesemia with clinically-significant sequelae
Measured: First 21-day treatment cycle
MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).
Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with DLTs during the first treatment cycle (Dose escalation part).
Measured: First treatment cycle

Secondary outcomes (6)

Dose Limiting Toxicities During All Treatment Cycles
Number of patients with DLT occuring during all treatment cycle is presented
Measured: All treatment cycle (each treatment cycle of 21 days)
Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Cetuximab)
MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.
Measured: All treatment cycle (each treatment cycle of 21 days)
Best Overall Response
Best overall response (according to RECIST version 1.1) was defined as the best response recorded at any time from the first administration of afatinib or cetuximab to the End of Treatment (EOT).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Objective Response
Objective response was defined as the proportion of patients with measurable disease having at least a best overall response of complete response (CR) or partial response (PR), according to RECIST version 1.1.
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Disease Control Rate
For patients with measurable disease, disease control was defined as the proportion of patients having at least a best overall response of CR, PR or stable disease (SD).
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
Measured: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Afatinib)
MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.
Measured: All treatment cycle (each treatment cycle of 21 days)

Timeline

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

Dec 2013Apr 2016

First posted25 Dec 2013 (estimated)
Study startDec 2013
Primary completionJan 2015
Study completionApr 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02020577
Sponsor's protocol ID: 1200.122
Other IDs: 2012-005230-10
Status last verified: May 2017
First submitted: 19 Dec 2013
Last updated: 22 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Gazzah A, Boni V, Soria JC, Calles A, Even C, Doger B, Mahjoubi L, Bahleda R, Ould-Kaci M, Esler A, Nazabadioko S, Calvo E. A phase 1b study of afatinib in combination with standard-dose cetuximab in patients with advanced solid tumours. Eur J Cancer. 2018 Nov;104:1-8. doi: 10.1016/j.ejca.2018.07.011. Epub 2018 Oct 1.
PubMed 30278378

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Dose Escalation Study of Afatinib in Combination With Cetuximab in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT02020577
Acronym / sponsor ID: 1200.122
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Jan 2015 (actual)
Study completion: Apr 2016 (actual)
First posted: 25 Dec 2013 (estimated)
Results: Posted 12 Feb 2016

Clinical summary

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

Study design

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

Arm	Type	Receives
combination arm	Experimental	Drug: Cetuximab( erbitux®), Drug: AfatinibPatients to receive afatinib once daily plus weekly cetuximab infusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Part A only
Patients must have advanced malignant solid tumours that are metastatic or unresectable
At least one measurable or evaluable (non-measurable) lesion per RECIST 1.1 Part B only
Patients must have:
or

Key exclusion criteria (23 listed)

Chemotherapy, biological therapy or investigational agents within 4 weeks prior to the start of study treatment.
Hormonal anti-cancer treatment within 2 weeks prior to the start of study treatment (continued use of anti-androgens and/or gonadorelin analogues [LHRH] is permitted)
Radiotherapy within 4 weeks prior to the start of study treatment, except as follows:
Major surgery (as judged by the investigator) within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
Known hypersensitivity to afatinib or the excipients of any of the trial drugs

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
Cetuximab( erbitux®)once per week	Drug	combination arm
Afatinibonce per day	Drug	combination arm

Primary outcome

MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).
Time frame: First 21 days treatment cycle
Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.
Dose Limiting Toxicities During Cycle 1
Time frame: First 21-day treatment cycle
Number of Patients With Dose Limiting Toxicity (DLT) Occurring during Cycle 1. The following drug related AEs qualified as DLT: 1) CTCAE Grade ≥2 decrease in cardiac left ventricular function 2) CTCAE Grade 2 diarrhoea lasting for ≥7 days, despite appropriate use of standard antidiarrheal therapy based on Protocol Amendment 1 dated 22 Oct 2013 3) CTCAE Grade ≥3 diarrhoea despite appropriate use of standard anti-diarrheal therapy for at least 2 days. 4) CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days 5) CTCAE Grade ≥3 rash despite standard medical management. 6) CTCAE Grade ≥3 fatigue lasting more than 7 days. 7) All other AEs of CTCAE Grade ≥3 (except alopecia and allergic reaction) that led to an interruption of afatinib and/or cetuximab dosing for more than 14 days until recovery to baseline or Grade 1, whichever was higher. 8) CTCAE Grade 4 hypomagnesemia or Grade 3 hypomagnesemia with clinically-significant sequelae
MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).
Time frame: First treatment cycle
Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with DLTs during the first treatment cycle (Dose escalation part).

6 secondary outcomes

Dose Limiting Toxicities During All Treatment Cycles
Time frame: All treatment cycle (each treatment cycle of 21 days)
Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Cetuximab)
Time frame: All treatment cycle (each treatment cycle of 21 days)
Best Overall Response
Time frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Objective Response
Time frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Disease Control Rate
Time frame: Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months
Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Afatinib)
Time frame: All treatment cycle (each treatment cycle of 21 days)

Results and safety

Results posted to the registry on 12 Feb 2016, 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 30mg+Cetuximab 250 mg/m²	3	0
Afatinib 40mg+Cetuximab 250 mg/m²	55	0

Primary outcome: MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).

Time frame: First 21 days treatment cycle. Number. Unit: mg

Measure	Afatinib 30mg+Cetuximab 250 mg/m² n = 3	Afatinib 40mg+Cetuximab 250 mg/m² n = 6
Value	NA	40

Population analysed: Dose finding cohort treated set: This patient set includes all patients enrolled in part A of the trial who were documented to have taken at least one dose of study medication.

Primary outcome: Dose Limiting Toxicities During Cycle 1

Time frame: First 21-day treatment cycle. Number. Unit: Participants

Measure	Afatinib 30mg+Cetuximab 250 mg/m² n = 3	Afatinib 40mg+Cetuximab 250 mg/m² n = 6
Value	0	0

Population analysed: Dose finding cohort treated set.

Primary outcome: MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).

Time frame: First treatment cycle. Number. Unit: mg/m2

Measure	Afatinib 30mg+Cetuximab 250 mg/m² n = 3	Afatinib 40mg+Cetuximab 250 mg/m² n = 6
Value	NA	250

Population analysed: Dose finding cohort treated set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after last drug administration, up to 19 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib 30mg+Cetuximab 250 mg/m²	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Afatinib 40mg+Cetuximab 250 mg/m²	31 of 55 (56.4%)	54 of 55 (98.2%)	Not reported
All Patients	32 of 58 (55.2%)	57 of 58 (98.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30278378Gazzah A, Boni V, Soria JC, Calles A, Even C, Doger B, Mahjoubi L, Bahleda R, Ould-Kaci M, Esler A, Nazabadioko S, Calvo E. A phase 1b study of afatinib in combination with standard-dose cetuximab in patients with advanced solid tumours. Eur J Cancer. 2018 Nov;104:1-8. doi: 10.1016/j.ejca.2018.07.011. Epub 2018 Oct 1.

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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

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetuximab( erbitux®) and Afatinib in people with Neoplasms, run by Boehringer Ingelheim at 2 sites in 2 countries.

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 23 inclusion and 23 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Spain. 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 12 Feb 2016). 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?

MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib). (time frame: First 21 days treatment cycle). The study lists 3 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 NCT02020577, which also lists 1 linked publication.

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 22 Jun 2017.