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Lung CancerPhase 2TIDAL1NCT01405846

Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib

A Phase 2 study testing Gefitinib in people with Lung Cancer and Head and Neck Cancer, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.

Terminated

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

Official record
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Trial summary

We are going to use a special type of bronchoscopy test to examine patients who have had previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine a) whether we can identify precancerous changes in their airways b) whether this type of testing is acceptable and c) get an initial idea… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Cancer, Head and Neck Cancer
What is being tested?
Gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2011to Jun 2016
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Diagnosis of any second malignancy within the 5 years from date of enrolment, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
  • Evidence of severe or uncontrolled systemic disease or psychiatric disorder that would interfere with the patient's safety
  • Known severe hypersensitivity to Gefitinib or any of the excipients of the product
  • Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
  • Pre-existing idiopathic pulmonary fibrosis
  • History of allergy to contrast medium
Show all 17Show fewer
  • Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of < 9.3kpa
  • Inability to swallow oral medications
  • Presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhoea or any condition which would interfere with absorption of an oral drug.
  • Past medical history of keratitis
  • Past medical history of Sjogren's syndrome
  • Pregnant or breast-feeding
  • Male and female patients (of childbearing age) not using, or not willing to use, protocol mandated contraception
  • Prior EGFR inhibitor use.
  • Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing within 7 days of date of enrolment (e.g.. ketoconazole, rifampin, phenytoin, carbamazepine, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum etc.) or use of other concomitant medication incompatible with study drug (see SmPC)
  • Current treatment on another therapeutic clinical trial or previous investigational agent in the last 12 weeks (supportive care trials or non-treatment trials are allowed)
  • Previous enrolment or treatment in the present study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Papworth Hospital NHS Trust

    Papworth Everard, Cambs, CB23 3RE

Other trials in United Kingdom

About this study

Official title: Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium

We are going to use a special type of bronchoscopy test to examine patients who have had previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine a) whether we can identify precancerous changes in their airways b) whether this type of testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has any effect on precancerous areas in the airway.

Being tested
Gefitinib
Medical subject headings
Lung Neoplasms, Head and Neck Neoplasms

What participants receive

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

  • GefitinibDrug

    Also called IRESSA

    250mg od for 6 months

Study groups in NCT01405846
Study groupRoleWhat they receive
GefitinibOtherSingle arm study
Receives: Drug: Gefitinib

What is being measured

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

  1. Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia

    Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.

    Measured: during the screening broncoscopy - carried out within the first month post consent

Secondary outcomes (4)

  1. Acceptability of screening patients as measured by success of trial recruitment

    Measured: 12 months

  2. Response of high grade dysplasia to treatment (complete / partial / stable / progression)

    To be estimated by photography \& biopsy of the lesions \& comparison with previous findings:

    Complete response: Complete resolution of a dysplastic lesion Partial response: Reduction of a dysplastic lesion by >=50% OR Reduction in grade of a high grade dysplastic lesion Progressive disease: Development of a new area of high grade dysplasia or invasive malignancy in an area of previous low grade dysplasia or normal epithelium OR Development of a higher grade lesion in an area of previous high grade dysplasia OR Increase in surface area of >=50%.

    Stable disease: None of the above.

    Measured: 6 & 12 months

  3. Toxicity and acceptability of treatment (proportion of patients refusing study entry).

    Measured: 2 weeks, 4 weeks, 3 & 6 months

  4. Successful biobanking of samples

    Measured: 12 months

Timeline

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

  1. First posted29 Jul 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionApr 2016
  4. Study completionJun 2016

Why it stopped: Futility

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405846
Sponsor's protocol ID
P01425
Other IDs
2010-023355-29, 11/H0304/8
Acronym
TIDAL1
Status last verified
Aug 2016
First submitted
28 Jul 2011
Last updated
19 Aug 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefitinib in people with Lung Cancer and Head and Neck Cancer, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.

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 0 inclusion and 17 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 19 Aug 2016. 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 United Kingdom. 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?

The study was stopped early (reason given: Futility). 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?

Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia (time frame: during the screening broncoscopy - carried out within the first month post consent). 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 NCT01405846.

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 2016.

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