Carcinoma, Non-Small-Cell LungPhase 1NCT00993499

Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

A Phase 1 study testing BIBW 2992 and Sirolimus (rapamycin) in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 8 sites in Spain.

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 identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus. The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: BIBW 2992 and Sirolimus (rapamycin)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 8 sitesSpain
Study dates: Oct 2009to Sep 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

Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
Patients whose tumors:
are EGFR mutation-positive or
are EGFR mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
Patients aged 18 years or older

Show all 9Show fewer

Life expectancy of at least three (3) months
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0-2
Written informed consent that is consistent with ICH-GCP guidelines

Who cannot join

Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
Active CNS metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
Requirement for treatment with any of the prohibited concomitant medications:

Show all 11Show fewer

Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
Concomitant CYP3A4 inducers within the past 14 days before start of therapy or concomitantly with this study.
Any contraindications for therapy with Sirolimus.
Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
Use of any investigational drug within 4 weeks before start of therapy.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Spain8 sites

1200.70.34001 Boehringer Ingelheim Investigational Site
Badalona (Barcelona)
1200.70.34008 Boehringer Ingelheim Investigational Site
Barcelona
1200.70.34009 Boehringer Ingelheim Investigational Site
Barcelona
1200.70.34006 Boehringer Ingelheim Investigational Site
Girona
1200.70.34007 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1200.70.34005 Boehringer Ingelheim Investigational Site
Majadahonda (Madrid)
1200.70.34004 Boehringer Ingelheim Investigational Site
Valencia
1200.70.34002 Boehringer Ingelheim Investigational Site
Zaragoza

Other trials in Spain

About this study

Official title: A Phase Ib Open Label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Sirolimus in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus.

The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles.

Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: BIBW 2992, Sirolimus (rapamycin)
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

BIBW 2992Drug
Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs
Sirolimus (rapamycin)Drug
Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.

Study groups in NCT00993499
Study group	Role	What they receive
BIBW 2992 + Sirolimus	Experimental	Dose escalation of the combination BIBW 2992 plus Sirolimus. Receives: Drug: BIBW 2992; Drug: Sirolimus (rapamycin)

What is being measured

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

Occurrence of Dose Limiting Toxicities (DLT)
Number of participants with of dose limiting toxicities (DLT)
Measured: 2 first cycles, 56 days

Secondary outcomes (11)

Best Overall Response
Best overall response (unconfirmed) according to RECIST v1.1
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Objective Response
Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Rate of Disease Control
Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.
Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA.
This endpoint was not analysed in the study report as the available data was too limited.
Measured: Multiple time points during the trial
Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)
Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)
Measured: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib
AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)
Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.
Measured: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib
Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)
Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)
Measured: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib
AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)
Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.
Measured: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib
Occurrence of Adverse Events According to CTCAE, Version 3.0
Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Percentage of Patients With Drug-related AEs
Percentage of patients with drug-related adverse events (AEs).
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy's law cases.
Measured: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days

Timeline

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

Oct 2009Sep 2014

First posted12 Oct 2009 (estimated)
Study startOct 2009
Primary completionSep 2014
Study completionSep 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 Carcinoma, Non-Small-Cell LungStudies 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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00993499
Sponsor's protocol ID: 1200.70
Other IDs: 2009-010432-18, 2009
Status last verified: Sep 2015
First submitted: 8 Oct 2009
Last updated: 7 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Moran T, Palmero R, Provencio M, Insa A, Majem M, Reguart N, Bosch-Barrera J, Isla D, Costa EC, Lee C, Puig M, Kraemer S, Schnell D, Rosell R. A phase Ib trial of continuous once-daily oral afatinib plus sirolimus in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer and/or disease progression following prior erlotinib or gefitinib. Lung Cancer. 2017 Jun;108:154-160. doi: 10.1016/j.lungcan.2017.03.009. Epub 2017 Mar 22.
PubMed 28625629

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Open Label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Sirolimus in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
ClinicalTrials.gov ID: NCT00993499
Acronym / sponsor ID: 1200.70
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 12 Oct 2009 (estimated)
Results: Posted 7 Oct 2015

Clinical summary

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

The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus.

The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles.

Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.

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 + Sirolimus	Experimental	Drug: BIBW 2992, Drug: Sirolimus (rapamycin)Dose escalation of the combination BIBW 2992 plus Sirolimus.

Who may qualify

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

Key inclusion criteria (9 listed)

Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
Patients whose tumors:
Patients aged 18 years or older
Life expectancy of at least three (3) months

Key exclusion criteria (11 listed)

Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
Active CNS metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.

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 2992Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs	Drug	BIBW 2992 + Sirolimus
Sirolimus (rapamycin)Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.	Drug	BIBW 2992 + Sirolimus

Primary outcome

Occurrence of Dose Limiting Toxicities (DLT)
Time frame: 2 first cycles, 56 days
Number of participants with of dose limiting toxicities (DLT)

11 secondary outcomes

Best Overall Response
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Objective Response
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Rate of Disease Control
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.
Time frame: Multiple time points during the trial
Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)
Time frame: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib
AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)
Time frame: 24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib
Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)
Time frame: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib
AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)
Time frame: 24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib
Occurrence of Adverse Events According to CTCAE, Version 3.0
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Percentage of Patients With Drug-related AEs
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days
Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin
Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days

Results and safety

Results posted to the registry on 7 Oct 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
Afa30+Sir01	13	12
Afa30+Sir03	12	9
Afa30+Sir05	10	9
Afa30+Sir10	3	3
Afa40+Sir01	3	3
Afa40+Sir05	3	3

Primary outcome: Occurrence of Dose Limiting Toxicities (DLT)

Time frame: 2 first cycles, 56 days. Number. Unit: Participants

Measure	Afa30+Sir01 n = 12	Afa30+Sir03 n = 9	Afa30+Sir05 n = 9	Afa30+Sir10 n = 3	Afa40+Sir01 n = 3	Afa40+Sir05 n = 3
Value	3	2	4	3	2	3

Population analysed: Treated set

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afa30+Sir01	4 of 12 (33.3%)	12 of 12 (100%)	Not reported
Afa30+Sir03	6 of 9 (66.7%)	9 of 9 (100%)	Not reported
Afa30+Sir05	7 of 9 (77.8%)	8 of 9 (88.9%)	Not reported
Afa30+Sir10	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Afa40+Sir01	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Afa40+Sir05	2 of 3 (66.7%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28625629Moran T, Palmero R, Provencio M, Insa A, Majem M, Reguart N, Bosch-Barrera J, Isla D, Costa EC, Lee C, Puig M, Kraemer S, Schnell D, Rosell R. A phase Ib trial of continuous once-daily oral afatinib plus sirolimus in patients with epidermal growth factor receptor mutation-positive non-small cell lung cancer and/or disease progression following prior erlotinib or gefitinib. Lung Cancer. 2017 Jun;108:154-160. doi: 10.1016/j.lungcan.2017.03.009. Epub 2017 Mar 22.
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

8 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 BIBW 2992 and Sirolimus (rapamycin) in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 8 sites in Spain.

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 9 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in 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 7 Oct 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?

Occurrence of Dose Limiting Toxicities (DLT) (time frame: 2 first cycles, 56 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 NCT00993499, 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 7 Oct 2015.