Non-small Cell Lung CancerPhase 2NCT02055170
Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
A Phase 2 study testing finasteride 5mg oral daily in people with Non-small Cell Lung Cancer, run by CancerCare Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- finasteride 5mg oral daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to 27 Mar 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male
- age >18
- biopsy-proven non-small cell lung cancer
- surgical intervention planned
Who cannot join
- current use of 5-alpha reductase inhibitor
- previous diagnosis of prostate cancer
- previous hypersensitivity to 5-alpha reductase inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.
In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- finasteride 5mg oral daily
- 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.
finasteride 5mg oral dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| finasteride | Experimental | finasteride 5mg po od from study entry to date of surgery Receives: Drug: finasteride 5mg oral daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proliferation
Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).
Measured: Original biopsy to surgical specimen (approx 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJun 2014
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Why it stopped: Unable to improve on poor accrual to study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055170
- Sponsor's protocol ID
- HLC001
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02055170
- Acronym / sponsor ID
- HLC001
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to improve on poor accrual to study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.
In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| finasteride | Experimental | Drug: finasteride 5mg oral dailyfinasteride 5mg po od from study entry to date of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- age >18
- biopsy-proven non-small cell lung cancer
- surgical intervention planned
Key exclusion criteria (3 listed)
- current use of 5-alpha reductase inhibitor
- previous diagnosis of prostate cancer
- previous hypersensitivity to 5-alpha reductase inhibitor
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 |
|---|---|---|
| finasteride 5mg oral daily | Drug | finasteride |
Primary outcome
Change in proliferation
Time frame: Original biopsy to surgical specimen (approx 6 weeks)
Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).
Results and safety
The study was stopped early (reason given: Unable to improve on poor accrual to study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing finasteride 5mg oral daily in people with Non-small Cell Lung Cancer, run by CancerCare Manitoba at 1 site in Canada.
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 4 inclusion and 3 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 31 Aug 2018. 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 Canada. 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: Unable to improve on poor accrual to 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?
Change in proliferation (time frame: Original biopsy to surgical specimen (approx 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2018.