Radiation PneumonitisPhase 2NCT02296281
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
A Phase 2 study testing Pirfenidone in people with Radiation Pneumonitis, run by Beijing Continent Pharmaceutical Co, Ltd..
Trial summary
The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old (include 18 and 70 years), male or female
- The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
- General condition assessment, ECOG score of 0-1
- Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
- The expected survival at 6 months or more
- Subject is able to eat solid food
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- The initial radical thoracic radiotherapy treatment
- The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
- The duration of radiation-induced lung injury in less than 1 month
- Signed informed consent
Who cannot join
- Radiation-induced lung injury has entered the chronic phase
- A history of chronic bronchitis, emphysema, or a history of cor pulmonale
- Lung resection surgery
- Cancer progression
- Pulmonary infection
- Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
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- With active peptic ulcer
- Pregnant women and patients with mental disease
- Those who participate in clinical trials of other drugs within 3 months
- Investigator judge does not apply to participate in the trial
About this study
The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.
- Conditions
- Radiation Pneumonitis
- Being tested
- Pirfenidone
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in radiation-induced lung injury classification
Measured: 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation PneumonitisStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296281
- Sponsor's protocol ID
- GNI-F647-1401
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
- ClinicalTrials.gov ID
- NCT02296281
- Acronym / sponsor ID
- GNI-F647-1401
- Conditions
- Radiation Pneumonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Genomics, Inc., GNI-EPS Pharmaceuticals, Inc. (GNI Group)
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 20 Nov 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 assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Pirfenidone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-70 years old (include 18 and 70 years), male or female
- The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
- General condition assessment, ECOG score of 0-1
- Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
- The expected survival at 6 months or more
Key exclusion criteria (10 listed)
- Radiation-induced lung injury has entered the chronic phase
- A history of chronic bronchitis, emphysema, or a history of cor pulmonale
- Lung resection surgery
- Cancer progression
- Pulmonary infection
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 |
|---|---|---|
| Pirfenidone | Drug | treatment group |
Primary outcome
Changes in radiation-induced lung injury classification
Time frame: 36 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in people with Radiation Pneumonitis, run by Beijing Continent Pharmaceutical Co, Ltd..
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 10 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in radiation-induced lung injury classification (time frame: 36 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 20 Nov 2014.