Idiopathic Pulmonary FibrosisPhase 1ISLAND2NCT02648048
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing Pirfenidone and Vismodegib in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 15 sites in 2 countries.
Trial summary
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone and Vismodegib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 15 Jan 2016to 30 Nov 2016
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
- Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
- Greater than or equal to (>=) 50 percent (%) and less than or equal to (<=) 100% of predicted forced vital capacity (FVC) at screening
- Stable baseline lung function as evidenced by a difference of less than (<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
- >=30% and <=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
- Agree to use protocol defined methods of contraception
- Male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib
- Agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment
Who cannot join
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Evidence of other known causes of interstitial lung disease
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
- Lung transplant expected within 6 months of screening
- Evidence of clinically significant lung disease other than IPF
- Post-bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
Show all 12Show fewer
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <6 months, likely to require a change in therapy during the study
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
- Known current malignancy or current evaluation for a potential malignancy
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Creatinine clearance <=30 milliliter per minute, calculated using the Cockcroft-Gault formula
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine
Boston, Massachusetts, 02135
Suburban Lung Associates
Elk Grove, Illinois, 60007
Western Washington Medical Group
Everett, Washington, 98208
Pulmonix LLC
Greensboro, North Carolina, 27403
Scripps Clinic
La Jolla, California, 92037
University of Louisville
Louisville, Kentucky, 40202-1798
Medical Consultants, PC ; Pulmonary
Muncie, Indiana, 47303
Tulane University Medical School
New Orleans, Louisiana, 70112
Creighton University Medical Center
Omaha, Nebraska, 68131
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Allied Clinical Research
Reno, Nevada, 89503
Swedish Medical Center
Seattle, Washington, 98122
Atlantic Respiratory Institute
Summit, New Jersey, 07901
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Germany1 site
Fraunhofer-Institut fur Toxikologie und Experimentelle Medizin ITEM
Hanover, 30625
About this study
Official title: A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Pirfenidone, Vismodegib
- Keywords
- Idiopathic Pulmonary Fibrosis, Vismodegib, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called RO0220912
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
VismodegibDrug
Also called RO5450815
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
| Study group | Role | What they receive |
|---|---|---|
| Vismodegib and Pirfenidone | Experimental | Participants being treated with pirfenidone, will receive vismodegib 150 milligrams (mg) once daily and pirfenidone up to 2403 mg daily orally for 24 weeks. Receives: Drug: Pirfenidone; Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Serious and Non-Serious Adverse Events
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. A serious adverse event is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to 28 weeks
Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. Relatedness to the study drug will be assessed by the investigator.
Measured: Baseline up to 28 weeks
Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
Measured: Baseline up to 28 weeks
Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator
Vital signs and laboratory parameters will be evaluated, and percentage of participants with any clinically meaningful abnormalities as assessed by Investigator will be reported. Laboratory abnormalities of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than (>) 3 will be considered clinical meaningful.
Measured: Baseline up to 28 weeks
Secondary outcomes (4)
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + alpha-1-acid glycoprotein (AAG)-bound vismodegib plasma concentration.
Measured: Predose (0 hour) at Week 4
Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Measured: Predose (0 hour) at Week 12
Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Measured: Predose (0 hour) at Week 24
Total and Free Trough Plasma Concentrations of Vismodegib at Safety Follow-up Visit (Cmin, SFU)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Measured: At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start15 Jan 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648048
- Sponsor's protocol ID
- GB29764
- Other IDs
- 2015-003481-81, 2015
- Acronym
- ISLAND2
- Status last verified
- Oct 2017
- First submitted
- 5 Jan 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
Publications
Prasse A, Ramaswamy M, Mohan S, Pan L, Kenwright A, Neighbors M, Belloni P, LaCamera PP. A Phase 1b Study of Vismodegib with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Pulm Ther. 2019 Dec;5(2):151-163. doi: 10.1007/s41030-019-0096-8. Epub 2019 Jul 19.
PubMed 32026407
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02648048
- Acronym / sponsor ID
- ISLAND2 / GB29764
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Vismodegib, Pirfenidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 6 Jan 2016 (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.
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vismodegib and Pirfenidone | Experimental | Drug: Pirfenidone, Drug: VismodegibParticipants being treated with pirfenidone, will receive vismodegib 150 milligrams (mg) once daily and pirfenidone up to 2403 mg daily orally for 24 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
- Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
- Greater than or equal to (>=) 50 percent (%) and less than or equal to (<=) 100% of predicted forced vital capacity (FVC) at screening
- Stable baseline lung function as evidenced by a difference of less than (<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
- >=30% and <=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
Key exclusion criteria (12 listed)
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Evidence of other known causes of interstitial lung disease
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
- Lung transplant expected within 6 months of screening
- Evidence of clinically significant lung disease other than IPF
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 |
|---|---|---|
| PirfenidoneAlso: RO0220912Pirfenidone will be administered as per the dosage schedule mentioned in arm description. | Drug | Vismodegib and Pirfenidone |
| VismodegibAlso: RO5450815Vismodegib will be administered as per the dosage schedule mentioned in arm description. | Drug | Vismodegib and Pirfenidone |
Primary outcome
Percentage of Participants with Serious and Non-Serious Adverse Events
Time frame: Baseline up to 28 weeks
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. A serious adverse event is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event
Time frame: Baseline up to 28 weeks
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. Relatedness to the study drug will be assessed by the investigator.
Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events
Time frame: Baseline up to 28 weeks
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator
Time frame: Baseline up to 28 weeks
Vital signs and laboratory parameters will be evaluated, and percentage of participants with any clinically meaningful abnormalities as assessed by Investigator will be reported. Laboratory abnormalities of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than (>) 3 will be considered clinical meaningful.
4 secondary outcomes
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
Time frame: Predose (0 hour) at Week 4
Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)
Time frame: Predose (0 hour) at Week 12
Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)
Time frame: Predose (0 hour) at Week 24
Total and Free Trough Plasma Concentrations of Vismodegib at Safety Follow-up Visit (Cmin, SFU)
Time frame: At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 32026407Prasse A, Ramaswamy M, Mohan S, Pan L, Kenwright A, Neighbors M, Belloni P, LaCamera PP. A Phase 1b Study of Vismodegib with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Pulm Ther. 2019 Dec;5(2):151-163. doi: 10.1007/s41030-019-0096-8. Epub 2019 Jul 19.
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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.
Clinical Trials study director
Hoffmann-La Roche
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone and Vismodegib in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 30 Oct 2017. 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, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Serious and Non-Serious Adverse Events (time frame: Baseline up to 28 weeks). The study lists 4 primary outcomes in all. 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 NCT02648048, which also lists 1 linked publication.
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 30 Oct 2017.