Cystic FibrosisPhase 2ROSCO-CFNCT02649751
Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
A Phase 2 study testing Roscovitine in people with Cystic Fibrosis, run by University Hospital, Brest at 11 sites in France.
Trial summary
This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Roscovitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 11 sitesFrance
- Study dates
- 22 Feb 2016to 26 Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged over 18 years of age on the date of informed consent;
- Diagnosed CF patients. Confirmed diagnosis of CF (Rosenstein and Cutting, 1998);
- Patients carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation, genotype to be confirmed at screening;
- Forced expiratory volume at 1 second (FEV1) 40%
- Chronic lung Pseudomonas aeruginosa infection according to the definition from the French Consensus Conference;
- Able to understand and comply with all protocol requirements, restrictions and instructions and likely to complete the study as planned (as judged by the investigator);
- Provide written informed consent prior to the performance of any study-related procedure;
Who cannot join
- Acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before V2;
- Recent patient reported history of:
- non recovered viral upper respiratory tract infection
- solid organ or hematological transplantation
- Burkholderia cepacia complex or Non Tuberculous Mycobacteria (NTM) respiratory tract infection;
- Undergone major surgery within 1 month prior to screening;
Show all 26Show fewer
- Currently treated allergic broncho-pulmonary aspergillosis (ABPA);
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%;
- Hemoptysis more than 60 mL at any time within 4 weeks prior to first study drug administration (V2);
- History of any other comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject;
- Any other clinically significant conditions (not associated with the study indication) at Screening (V1) which might interfere with the assessment of this study;
- Any of the following abnormal laboratory values at screening:
- Hemoglobin <10 g/dL
- Abnormal liver function
- Serum K+ <3,5 mmol/L
- Abnormal renal function
- Any clinically significant laboratory abnormalities;
- Patients who have clinically significant impairment in cardiovascular function;
- Concomitant disease(s) that could prolong the QT interval;
- Patients with a history of alcohol or drug abuse in the past year;
- Patients with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable;
- Use of one (or several) prohibited medications and/or food;
- Administration of any investigational drug within 30 days prior to Screening (V1) or 5 half-lives, whichever is longer;
- Use of systemic anti-pseudomonal antibiotics within 28 days prior to first study drug administration (V2). However use of inhaled anti-pseudomonal antibiotic treatment is allowed if initiated for more than 28 days;
- Use of loop diuretics within 7 days prior to first study drug administration (V2);
- Pregnant or nursing females.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHR - Hôpital Calmette
Lille, 59037
CH Lyon Sud
Lyon, 69495
Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHU Nantes
Nantes, 44093
CHU de Nice - Hôpital Pasteur
Nice, France, 06001
Hôpital Cochin
Paris, 75014
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604
Centre de Ressources et de Compétences de la mucoviscidose
Reims, France, 51100
Centre de Perharidy
Roscoff, 29684
Hôpital Larrey
Toulouse, 30030
Centre Hospitalier Bretagne Atlantique
Vannes, France, 56017
About this study
Official title: A Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF.
This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study.
The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.
Read the detailed description
ROSCO-CF is a phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and effects of (R)-roscovitine in subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in 36 adult cystic fibrosis subjects.
These 36 patients will be allocated to 3 groups of 12 subjects who will be randomized in a 2:1 ratio (active drug to matching placebo). In each group, 8 patients will receive roscovitine (200 mg, 400 mg, 2 X 400 mg in group 1, 2 and 3, respectively) and 4 will receive a matching placebo. Treatment will be provided by oral administration of capsules. Each patient will receive the same treatment throughout the 28 day study.
This phase II trial will give some preliminary information about safety and hints of effects of a new experimental treatment. If the data suggest that a short term treatment with roscovitine provides a safe, effective and convenient approach for CF patients chronically infected with Pseudomonas aeruginosa, patients participating in this proof of concept trial will be offered to participate in further longer term studies.
- Conditions
- Cystic Fibrosis
- Being tested
- Roscovitine, Placebo
- Keywords
- Cystic Fibrosis, Roscovitine, Seliciclib, CYC202
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoscovitineDrug
Also called Seliciclib, CYC202
Roscovitine is an experimental drug candidate in the family of pharmacological cyclin-dependent kinase (CDK) inhibitors that preferentially inhibit multiple enzyme targets including CDK2, CDK7 and CDK9. Seliciclib is a 2,6,9-substituted purine analog.
PlaceboDrug
The placebo treatment is lactose capsule.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 200 mg roscovitine (8) or placebo (4) once daily for 4 cycles of 7 days (4 days "on" and 3 days "off") Receives: Drug: Roscovitine; Drug: Placebo |
| Group 2 | Experimental | 400 mg roscovitine (8) or placebo (4) once daily for 4 cycles of 7 days (4 days "on" and 3 days "off") Receives: Drug: Roscovitine; Drug: Placebo |
| Group 3 | Experimental | 400 mg roscovitine (8) or (4) placebo twice daily for cycles of 7 days (4 days "on" and 3 days "off") Receives: Drug: Roscovitine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of increasing doses of Roscovitine
The primary objective of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects who carrying 2 Cystic Fibrosis causing mutations with at least F508del mutation
Measured: 3 months
Secondary outcomes (10)
Change in the concentration of Pseudomonas Aeruginosa
Change in the concentration (CFU/mL) of Pseudomonas aeruginosa in the sputum at each visit from V1 (Screening) up to V7 (Completion Visit).
Measured: 3 months
PK parameters
PK parameters: Maximum Concentration (Cmax), Time to reach Cmax (Tmax), Area Under Curve (AUCt and AUCInf), Half-life (t1/2) for roscovitine and its M3 metabolite.
Measured: 3 months
Pro- and anti-inflammatory cytokines
Monitoring the levels of pro- and anti-inflammatory cytokines, in particular: interleukin (IL)-17A, IL-5, IFN-γ, IL-1 receptor antagonist, IL-4, IL-6, IL-10, tumor necrosis factor-alpha, and IL-18 on V2, V3 and V7 (Completion Visit)
Measured: 3 months
C-reactive protein
Change in C-reactive protein (CRP) at each visit from V1 (Screening) up to V7 (Completion)
Measured: 3 months
Cystic Fibrosis Questionnaire-Revised
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) at each visit from V1 up to V8 (Safety Follow-up)
Measured: 3 months
Body Mass Index
Change in body mass index (BMI) at each visit from V1 (Screening) up to V7 (Completion Visit)
Measured: 3 months
Forced expiratory volume in 1 second
Change in forced expiratory volume in 1 second (FEV1) at each visit from V1 (Screening) up to V7 (Completion Visit)
Measured: 3 months
Sweat Chloride Concentration
Change in Sweat Chloride Concentration at V2, V3, V5 and V7 (Completion)
Measured: 3 months
Nasal Potential Difference
Change in Nasal Potential Difference (NPD) at V1 (Screening) and V6 (for patients included in Paris Cochin CF Center)
Measured: 3 months
Pain questionnaire
Evaluate of the pain and of the impact of the pain in patients with cystic fibrosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start22 Feb 2016
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Why it stopped: The centers have no longer patients. In September 2018, set up of a competitive international study.
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 Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- ManRos Therapeutics, Cyclacel Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Gilles RAULT, MD, Principal investigator, Centre de Pérharidy - Roscoff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649751
- Sponsor's protocol ID
- RB 15.098 (ROSCO CF)
- Acronym
- ROSCO-CF
- Status last verified
- Jul 2018
- First submitted
- 6 Jan 2016
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meijer L, Hery-Arnaud G, Leven C, Nowak E, Hillion S, Renaudineau Y, Durieu I, Chiron R, Prevotat A, Fajac I, Hubert D, Murris-Espin M, Huge S, Danner-Boucher I, Ravoninjatovo B, Leroy S, Macey J, Urban T, Rault G, Mottier D, Berre RL. Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa, a randomized, placebo-controlled study. J Cyst Fibros. 2022 May;21(3):529-536. doi: 10.1016/j.jcf.2021.10.013. Epub 2021 Dec 24.
PubMed 34961705
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF.
- ClinicalTrials.gov ID
- NCT02649751
- Acronym / sponsor ID
- ROSCO-CF / RB 15.098 (ROSCO CF)
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Roscovitine, Seliciclib, CYC202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The centers have no longer patients. In September 2018, set up of a competitive international study.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- ManRos Therapeutics, Cyclacel Pharmaceuticals, Inc.
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 7 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 phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study.
The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.
Detailed description
ROSCO-CF is a phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and effects of (R)-roscovitine in subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in 36 adult cystic fibrosis subjects.
These 36 patients will be allocated to 3 groups of 12 subjects who will be randomized in a 2:1 ratio (active drug to matching placebo). In each group, 8 patients will receive roscovitine (200 mg, 400 mg, 2 X 400 mg in group 1, 2 and 3, respectively) and 4 will receive a matching placebo. Treatment will be provided by oral administration of capsules. Each patient will receive the same treatment throughout the 28 day study.
This phase II trial will give some preliminary information about safety and hints of effects of a new experimental treatment. If the data suggest that a short term treatment with roscovitine provides a safe, effective and convenient approach for CF patients chronically infected with Pseudomonas aeruginosa, patients participating in this proof of concept trial will be offered to participate in further longer term studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Roscovitine, Drug: Placebo200 mg roscovitine (8) or placebo (4) once daily for 4 cycles of 7 days (4 days "on" and 3 days "off") |
| Group 2 | Experimental | Drug: Roscovitine, Drug: Placebo400 mg roscovitine (8) or placebo (4) once daily for 4 cycles of 7 days (4 days "on" and 3 days "off") |
| Group 3 | Experimental | Drug: Roscovitine, Drug: Placebo400 mg roscovitine (8) or (4) placebo twice daily for cycles of 7 days (4 days "on" and 3 days "off") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged over 18 years of age on the date of informed consent;
- Diagnosed CF patients. Confirmed diagnosis of CF (Rosenstein and Cutting, 1998);
- Patients carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation, genotype to be confirmed at screening;
- Forced expiratory volume at 1 second (FEV1) 40%
- Chronic lung Pseudomonas aeruginosa infection according to the definition from the French Consensus Conference;
Key exclusion criteria (26 listed)
- Acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before V2;
- Recent patient reported history of:
- Undergone major surgery within 1 month prior to screening;
- Currently treated allergic broncho-pulmonary aspergillosis (ABPA);
- Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%;
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 |
|---|---|---|
| RoscovitineAlso: Seliciclib, CYC202Roscovitine is an experimental drug candidate in the family of pharmacological cyclin-dependent kinase (CDK) inhibitors that preferentially inhibit multiple enzyme targets including CDK2, CDK7 and CDK9. Seliciclib is a 2,6,9-substituted purine analog. | Drug | Group 1, Group 2, Group 3 |
| PlaceboThe placebo treatment is lactose capsule. | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Safety of increasing doses of Roscovitine
Time frame: 3 months
The primary objective of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects who carrying 2 Cystic Fibrosis causing mutations with at least F508del mutation
10 secondary outcomes
Change in the concentration of Pseudomonas Aeruginosa
Time frame: 3 months
PK parameters
Time frame: 3 months
Pro- and anti-inflammatory cytokines
Time frame: 3 months
C-reactive protein
Time frame: 3 months
Cystic Fibrosis Questionnaire-Revised
Time frame: 3 months
Body Mass Index
Time frame: 3 months
Forced expiratory volume in 1 second
Time frame: 3 months
Sweat Chloride Concentration
Time frame: 3 months
Nasal Potential Difference
Time frame: 3 months
Pain questionnaire
Time frame: 3 months
Results and safety
The study was stopped early (reason given: The centers have no longer patients. In September 2018, set up of a competitive international study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Results publication: PubMed 34961705Meijer L, Hery-Arnaud G, Leven C, Nowak E, Hillion S, Renaudineau Y, Durieu I, Chiron R, Prevotat A, Fajac I, Hubert D, Murris-Espin M, Huge S, Danner-Boucher I, Ravoninjatovo B, Leroy S, Macey J, Urban T, Rault G, Mottier D, Berre RL. Safety and pharmacokinetics of Roscovitine (Seliciclib) in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa, a randomized, placebo-controlled study. J Cyst Fibros. 2022 May;21(3):529-536. doi: 10.1016/j.jcf.2021.10.013. Epub 2021 Dec 24.
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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.
Gilles RAULT, MD principal investigator
Centre de Pérharidy - Roscoff
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roscovitine in people with Cystic Fibrosis, run by University Hospital, Brest at 11 sites in France.
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 7 inclusion and 26 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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: The centers have no longer patients. In September 2018, set up of a competitive international 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?
Safety of increasing doses of Roscovitine (time frame: 3 months). 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 NCT02649751, 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 12 Dec 2025.