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NeoplasmsPhase 2NCT00748709

Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.

A Phase 2 study testing BIBW 2992 (Afatinib) in people with Neoplasms, run by Boehringer Ingelheim at 15 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Neoplasms
What is being tested?
BIBW 2992 (Afatinib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
15 sitesin 2 countries
Study dates
1 Oct 2008to 1 Nov 2010
Phase
Phase 2
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • There are 2 Steps in the screening process:
  • Step 1 Inclusion criteria for pre-screening:
  • Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories:
  • Category 1, Gastric, GE junction, or Esophageal cancer Category 2, Biliary or gallbladder cancer Category 3, TCC urothelial tract, and Category 4, Gynecological cancers
  • Measurable disease by RECIST criteria.
  • Willingness and ability to give written informed consents consistent with ICHGCP guidelines.
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  • Life expectancy of at least three (3) months.
  • Eastern Cooperative Oncology Group performance score 0, 1 or 2.
  • Age >18 years.
  • Step 2 Inclusion criteria for enrollment:
  • Patients who have tested positive for FISH and are considered candidate for this trial must meet all of the following inclusion criteria:
  • Histologically confirmed diagnosis of advanced cancer of one of the following four tumor type categories:
  • Category 1, Gastric, GE junction, or Esophageal cancer Category 2, Biliary or gallbladder cancer Category 3, TCC urothelial tract, and Category 4, Gynecological cancers
  • Documented failure to respond or progression of underlying cancer after at least one line of prior chemotherapy.
  • EGFR and/or HER2 gene amplification by FISH testing or patients with tumors that harbor known activating EGFR mutations.
  • Measurable disease by RECIST criteria.
  • Willingness and ability to give written informed consents consistent with ICH-GCP guidelines.
  • Life expectancy of at least three (3) months.
  • Eastern Cooperative Oncology Group performance score 0, 1 or 2.
  • Age >18 years.

Who cannot join

  • Prior treatment with gefitinib, erlotinib, lapatinib and/or other EGFR TKIs.
  • Treatment with cytotoxic anti-cancer-therapies or investigational drugs during the last four weeks prior to the first treatment with the trial drug. (a shorter duration may be considered for patients treated with oral, non cytotoxic drugs on an individual basis and upon discussion between the principal investigator and sponsor)
  • Inability to take BIBW 2992 by mouth (BIBW 2992 may not be crushed or administered via Gastrostomy-tube)
  • Chronic diarrhea or other gastrointestinal disorders that may interfere with the absorption of the trial drug.
  • History of other malignancies unless free of disease for at least 3 years (except for appropriately treated superficial non-melanoma skin cancer and surgically cured cervical cancer in situ).
  • 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. Myocardial infarction within 6 months prior to randomization.
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  • Resting left ventricular ejection fraction <50% OR below the institution's lower limit of normal (if the institutions lower limit is above 50%), measured by MUGA scan or echocardiogram.
  • Active infectious disease
  • Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with participation in this trial.
  • Active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal brain MRI scan at screening and be at least three months post-radiation or surgery for brain metastasis.
  • Absolute Neutrophil Count (ANC) less than 1,000/mm3.
  • Platelet count less than 100,000/mm3.
  • Hemoglobin Level less than 9.0 grams/dl.
  • Total Bilirubin greater than 1.5 mg/dl; higher Total Bilirubin values may be acceptable for patients with known Gilbert¿s disease, approval by the PI and sponsor will be necessary.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal; or 5 times the upper limit of normal in patients with neoplastic liver involvement.
  • Serum creatinine greater than 1.5 x upper limit of normal for the institution.
  • Patients who are sexually active and unwilling to use simultaneously two medically acceptable method of contraception, one of which being a barrier type method such as condom.
  • Pregnancy or breast-feeding.
  • Patients unable to comply with the protocol
  • Active alcohol and/or substance abuse.
  • Continuation of therapy-related toxicities from prior anti cancer therapies, prior surgery, of CTCAE Grade >=2 at the time of the first administration of the trial drug.
  • Patients with known pre-existing interstitial lung disease.
  • Requirement for treatment with any of the prohibited concomitant medications: additional experimental anti-cancer treatment and/or standard chemotherapy, immunotherapy, hormone treatment or radiotherapy; P-gp inhibitors

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States12 sites

  • 1200.26.4 Boehringer Ingelheim Investigational Site

    Albany, New York

  • 1200.26.1 Boehringer Ingelheim Investigational Site

    Boston, Massachusetts

  • 1200.26.12 Boehringer Ingelheim Investigational Site

    Dallas, Texas

  • 1200.26.11 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 1200.26.9 Boehringer Ingelheim Investigational Site

    Indianapolis, Indiana

  • 1200.26.7 Boehringer Ingelheim Investigational Site

    Kettering, Ohio

  • 1200.26.13 Boehringer Ingelheim Investigational Site

    Las Vegas, Nevada

  • 1200.26.3 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 1200.26.2 Boehringer Ingelheim Investigational Site

    New York, New York

  • 1200.26.6 Boehringer Ingelheim Investigational Site

    Norfolk, Virginia

  • 1200.26.8 Boehringer Ingelheim Investigational Site

    Tyler, Texas

  • 1200.26.10 Boehringer Ingelheim Investigational Site

    Vancouver, Washington

Other trials in United States

Taiwan3 sites

  • 1200.26.88603 Boehringer Ingelheim Investigational Site

    Tainan

  • 1200.26.88601 Boehringer Ingelheim Investigational Site

    Taipei

  • 1200.26.88602 Boehringer Ingelheim Investigational Site

    Taoyuan

Other trials in Taiwan

About this study

Official title: An Open Label Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification or EFGR Activating Mutations.

This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.

Conditions
Neoplasms
Being tested
BIBW 2992 (Afatinib)
Medical subject headings
Neoplasms

What participants receive

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

  • BIBW 2992 (Afatinib)Drug

    BIBW 2992 (Afatininb) for patients FISH positive for/or harboring EGFR or HER2 Mutation

Study groups in NCT00748709
Study groupRoleWhat they receive
BIBW 2992 (Afatinib)ExperimentalBIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation
Receives: Drug: BIBW 2992 (Afatinib)

What is being measured

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

  1. Percentage of Participants With Objective Response (OR)

    OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).

    Measured: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter

Secondary outcomes (8)

  1. Percentage of Participants With Clinical Benefit (CB)

    CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.

    Measured: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock

  2. Time to Objective Response (OR)

    The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.

    Measured: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock

  3. Duration of OR

    Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

    Measured: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.

  4. Progression-free Survival (PFS)

    PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.

    Measured: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.

  5. Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation

    Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation

    Measured: First administration of trial medication until 28 days after last administration of trial medication

  6. Maximum CTCAE Grade

    Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade

    Measured: First administration of trial medication until 28 days after last administration of trial medication

  7. Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15

    Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.

    Measured: Day 15

  8. Number of Patients With Diarrhea or Rash

    Number of Patients with Diarrhea or Rash

    Measured: First administration of trial medication until 28 days after last administration of trial medication

Timeline

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

  1. First posted9 Sep 2008 (estimated)
  2. Study start1 Oct 2008
  3. Primary completion1 Nov 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748709
Sponsor's protocol ID
1200.26
Status last verified
Jan 2025
First submitted
8 Sep 2008
Last updated
11 Feb 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBW 2992 (Afatinib) in people with Neoplasms, run by Boehringer Ingelheim at 15 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 20 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: stopped early, as of the sponsor's last update on 11 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 15 sites in United States, Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Oct 2013). 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?

Percentage of Participants With Objective Response (OR) (time frame: Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter). 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 NCT00748709.

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 11 Feb 2025.

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