NeoplasmsPhase 1NCT00998296

Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

A Phase 1 study testing BIBW 2992 and BIBF 1120 in people with Neoplasms, run by Boehringer Ingelheim at 1 site in France.

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

The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: BIBW 2992 and BIBF 1120
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteFrance
Study dates: Oct 2009to Jul 2014
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

Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
Age 18 years or older.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Patients previously treated and with asymptomatic brain metastases are eligible
Patients must have recovered from recent surgery.

Who cannot join

Active infectious disease
Recent surgery within the last 4 weeks prior visit 1.
Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
History of haemorrhagic or thrombotic events
Significant cardiovascular diseases within
Current peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma

Show all 11Show fewer

Untreated or symptomatic brain metastases or leptomeningeal disease.
Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
Therapeutic anticoagulation.
Female patients of childbearing potential.
Known pre-existing interstitial lung disease

Trial locations and contacts

1 site in 1 country.

France1 site

1239.14.3301A Boehringer Ingelheim Investigational Site
Villejuif

Other trials in France

About this study

Conditions: Neoplasms
Being tested: BIBW 2992, BIBF 1120
Medical subject headings: Neoplasms

What participants receive

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

BIBW 2992Drug
EGFR inhibitor
BIBF 1120Drug
VEGF inhibitor

Study groups in NCT00998296
Study group	Role	What they receive
BIBW 2992 + BIBF 1120	Experimental	This is a phase I dose escalation clinical trial and the data obtained shall determine the MTD for the combination of BIBW 2992/BIBF 1120 in 28-day of treatment. Receives: Drug: BIBW 2992; Drug: BIBF 1120

What is being measured

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

Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.
Measured: first treatment cycle, up to 28 days

Secondary outcomes (9)

Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient.
CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions
Measured: 6 weeks
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Measured: First treatment administration until cut-off date of 02Oct2014; up to 336 days
Changes in Safety Laboratory Parameters
Changes in safety laboratory Parameters reported as adverse events
Measured: First treatment administration until cut-off date of 02 October 2014, up to 336 days
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.)
As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)
Measured: Day 8, Day 15, Day 22 and Day 28
Trough Plasma Concentration of Afatinib at Steady State
C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose.
C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27.
Measured: Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28
Objective Response (OR) During the Expansion Phase
OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions.
CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Other factors which add to the overall response of an imaging timepoint as PR are as below:
CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'.
Measured: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Disease Control (DC) During the Expansion Phase
DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.
Measured: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Stable Disease for at Least 12 Weeks During the Expansion Phase
SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study.
PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.
PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.
Measured: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.
Measured: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)

Timeline

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

Oct 2009Jul 2014

First posted20 Oct 2009 (estimated)
Study startOct 2009
Primary completionDec 2012
Study completionJul 2014

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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00998296
Sponsor's protocol ID: 1239.14
Other IDs: 2009-011321-14, 2009
Status last verified: Jul 2015
First submitted: 19 Oct 2009
Last updated: 19 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Bahleda R, Hollebecque A, Varga A, Gazzah A, Massard C, Deutsch E, Amellal N, Farace F, Ould-Kaci M, Roux F, Marzin K, Soria JC. Phase I study of afatinib combined with nintedanib in patients with advanced solid tumours. Br J Cancer. 2015 Nov 17;113(10):1413-20. doi: 10.1038/bjc.2015.374. Epub 2015 Oct 29.
PubMed 26512876

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 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
ClinicalTrials.gov ID: NCT00998296
Acronym / sponsor ID: 1239.14
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2012 (actual)
Study completion: Jul 2014 (actual)
First posted: 20 Oct 2009 (estimated)
Results: Posted 9 Feb 2015

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
BIBW 2992 + BIBF 1120	Experimental	Drug: BIBW 2992, Drug: BIBF 1120This is a phase I dose escalation clinical trial and the data obtained shall determine the MTD for the combination of BIBW 2992/BIBF 1120 in 28-day of treatment.

Who may qualify

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

Key inclusion criteria (6 listed)

Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
Age 18 years or older.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Patients previously treated and with asymptomatic brain metastases are eligible

Key exclusion criteria (11 listed)

Active infectious disease
Recent surgery within the last 4 weeks prior visit 1.
Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
History of haemorrhagic or thrombotic events
Significant cardiovascular diseases within

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
BIBW 2992EGFR inhibitor	Drug	BIBW 2992 + BIBF 1120
BIBF 1120VEGF inhibitor	Drug	BIBW 2992 + BIBF 1120

Primary outcome

Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities
Time frame: first treatment cycle, up to 28 days
Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.

9 secondary outcomes

Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Time frame: 6 weeks
Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0
Time frame: First treatment administration until cut-off date of 02Oct2014; up to 336 days
Changes in Safety Laboratory Parameters
Time frame: First treatment administration until cut-off date of 02 October 2014, up to 336 days
Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)
Time frame: Day 8, Day 15, Day 22 and Day 28
Trough Plasma Concentration of Afatinib at Steady State
Time frame: Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28
Objective Response (OR) During the Expansion Phase
Time frame: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Disease Control (DC) During the Expansion Phase
Time frame: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Stable Disease for at Least 12 Weeks During the Expansion Phase
Time frame: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)
Percentage Change in the Tumour Size From Baseline During the Expansion Phase
Time frame: Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib 150 mg +Afatinib 30 mg - Continuously	6	6
Nintedanib 150 mg +Afatinib 40 mg - Continuously	3	2
Nintedanib 200 mg +Afatinib 10 mg - Continuously	3	3
Nintedanib 200 mg +Afatinib 20 mg - Continuously	3	3
Nintedanib 200 mg +Afatinib 30 mg - Continuously	8	6
Nintedanib 200 mg +Afatinib 40 mg - Continuously	3	3
Nintedanib 150 mg +Afatinib 40 mg - Intermittently	7	6
Nintedanib 200 mg +Afatinib 30 mg - Intermittently	6	4
Nintedanib 200 mg +Afatinib 40 mg - Intermittently	6	4
NSCLC	18	0
Pancreatic Adenocarcinoma	7	0

Primary outcome: Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities

Time frame: first treatment cycle, up to 28 days. Number. Unit: percentage of participants

Measure	Nintedanib 150 mg +Afatinib 40 mg - Continuously n = 3	Nintedanib 200 mg +Afatinib 30 mg - Continuously n = 8	Nintedanib 200 mg +Afatinib 40 mg - Continuously n = 3	Nintedanib 200 mg +Afatinib 30 mg - Intermittently n = 6	Nintedanib 200 mg +Afatinib 40 mg - Intermittently n = 6
Alanine aminotransferase increased	0.0	12.5	33.3	0.0	0.0
Aspartate aminotransferase increased	0.0	12.5	0.0	0.0	0.0
Blood creatinine increased	0.0	0.0	33.3	16.7	0.0
Dehydration	33.3	0.0	0.0	0.0	16.7
Diarrhoea	33.3	25.0	33.3	16.7	0.0
Hepatocellular injury	0.0	0.0	33.3	16.7	0.0
Renal failure acute	66.7	0.0	0.0	0.0	0.0
Hepatotoxicity	0.0	0.0	0.0	0.0	16.7

Population analysed: TS

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: First treatment administration until cut-off date of 02Oct2014; up to 336 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nintedanib 150 mg +Afatinib 30 mg - Continuously	3 of 6 (50%)	6 of 6 (100%)	Not reported
Nintedanib 150 mg +Afatinib 40 mg - Continuously	3 of 3 (100%)	3 of 3 (100%)	Not reported
Nintedanib 200 mg +Afatinib 10 mg - Continuously	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Nintedanib 200 mg +Afatinib 20 mg - Continuosly	0 of 3 (0%)	3 of 3 (100%)	Not reported
Nintedanib 200 mg +Afatinib 30 mg - Continuously	7 of 8 (87.5%)	8 of 8 (100%)	Not reported
Nintedanib 200 mg +Afatinib 40 mg - Continuously	3 of 3 (100%)	3 of 3 (100%)	Not reported
Nintedanib 150 mg +Afatinib 40 mg - Intermittently	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Nintedanib 200 mg +Afatinib 30 mg - Intermittently	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Nintedanib 200 mg +Afatinib 40 mg - Intermittently	4 of 6 (66.7%)	6 of 6 (100%)	Not reported
NSCLC	7 of 18 (38.9%)	18 of 18 (100%)	Not reported
Pancreatic Adenocarcinoma	3 of 7 (42.9%)	6 of 7 (85.7%)	Not reported

Limitations and caveats (from the sponsor): Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26512876Bahleda R, Hollebecque A, Varga A, Gazzah A, Massard C, Deutsch E, Amellal N, Farace F, Ould-Kaci M, Roux F, Marzin K, Soria JC. Phase I study of afatinib combined with nintedanib in patients with advanced solid tumours. Br J Cancer. 2015 Nov 17;113(10):1413-20. doi: 10.1038/bjc.2015.374. Epub 2015 Oct 29.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBW 2992 and BIBF 1120 in people with Neoplasms, run by Boehringer Ingelheim at 1 site in France.

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 6 inclusion and 11 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 9 Feb 2015). 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?

Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities (time frame: first treatment cycle, up to 28 days). 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 NCT00998296, 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 19 Aug 2015.