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Squamous Cell Carcinoma of EsophagusPhase 2NCT02353936

A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus

A Phase 2 study testing BIBW2992 in people with Squamous Cell Carcinoma of Esophagus, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Squamous Cell Carcinoma of Esophagus
What is being tested?
BIBW2992
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Jan 2015to Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed squamous cell carcinoma of esophagus
  • Age ≥ 20
  • ECOG PS 0-2
  • Ineligibility for local therapy (surgery or radiotherapy)
  • Patients who have failed to respond to or receive a first-line, palliative platinum-based chemotherapy
  • Allowed to enroll the patients who have developed the recurrent cancer within 6 months after definitive/neo-adjuvant/adjuvant platinum-based chemotherapy(± radiotherapy), by considering the prior therapy as first-line chemotherapy.
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  • Allowed to enroll the patients who cannot undergo platinum-based chemotherapy or concurrent chemo-radiotherapy due to concern for renal function deterioration and the patient intolerance, without prior chemotherapy history.
  • At least one bidimensionally measurable disease as defined by RECIST ver 1.1
  • Adequate organ function for treatment
  • Absolute neutrophil count (ANC) >=1000 cells/mm3
  • Platelets ≥ 100,000 cells/mm3
  • Estimated creatinine clearance ≥50 mL/min, or serum creatinine <1.5 x institution upper limit of normal (ULN) using Cockcroft and Gault formulas
  • Bilirubin ≤1.5 x ULN
  • AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
  • ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
  • 12-Lead electrocardiogram (ECG) with normal tracing or nonclinically significant changes that do not require medical intervention QTc interval ≤470 msec and without history of Torsades de Pointes or other symptomatic QTc abnormality
  • The patient who has signed the informed consent prior to conducting study related screening procedures, and who understands that the study may be discontinued at anytime without disadvantages

Who cannot join

  • Previous treatment with EGFR tyrosine kinase inhibitors
  • Chemotherapy , immunotherapy or investigational durg within 3 weeks of study entry
  • Any major operation or irradiation within 4 weeks of baseline disease assessment
  • Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  • Patients who confirmed CNS metastasis must have completed any prior treatment for CNS metastasis and steroid therapy for brain metastasis should stopped more 1week and stabled before first dose of study treatment
  • Patients with known interstitial lung disease
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  • Patients with uncontrolled or significant cardiovascular disease
  • Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, thyroid cancer, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry.
  • Pregnant or breast feeding women
  • Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance hospital

    Seoul, 120-752

Other trials in South Korea

About this study

As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. In a phase III study LUX-lung 3 in patients with EGFR mutation-positive non-small-cell lung cancer, afatinib monotherapy showed longer progression-free disease survival time of 11.1 months than that (6.9 months) of pemetrexed/cisplatin combination therapy. Based on such the results, it is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a patient with esophageal cancer had partial response. Taken together, based upon the results from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer.

Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer characterized by well-known EGFR overexpression. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.

Being tested
BIBW2992
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • BIBW2992Drug

    International Nonproprietary Name (INN): BIBW 2992 Pharmacological dosage form: Film-coated tablet Supplier: Boehringer Ingelheim Pharma GmbH \& Co. KG Unit content: 40 mg, 30 mg, 20 mg film-coated tablet (BIBW 2992 content in film-coated tablet is related with equivalent free base BIBW 2992.) Daily dose: 40 mg Dosing period: To be successively administered once daily until a disease will develop, an unacceptable adverse event will occur, or another reason requiring discontinuation of the study will occur; For administration, study treatment consists of periods(each 4 weeks(28 days)).

    Route of administration: Orally (Take by swallowing) Dosage: Once daily

Study groups in NCT02353936
Study groupRoleWhat they receive
afatinib groupExperimentalNot described
Receives: Drug: BIBW2992

What is being measured

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

  1. response rate

    Measured: every 8 weeks until 2 years

Secondary outcomes (1)

  1. Progression free survival

    Measured: 2 year

Timeline

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

  1. First posted3 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2020 (estimated)
  4. Study completionJan 2020 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353936
Sponsor's protocol ID
4-2014-0432
Status last verified
Feb 2019
First submitted
23 Jan 2015
Last updated
11 Feb 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBW2992 in people with Squamous Cell Carcinoma of Esophagus, run by Yonsei University at 1 site in South Korea.

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 17 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. 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 South Korea. 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?

Results are not available in the source record.

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?

response rate (time frame: every 8 weeks until 2 years). 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 NCT02353936.

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 2019.

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