Small Cell Lung CancerPhase 1NCT02913443
A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)
A Phase 1 study testing RO7051790 in people with Small Cell Lung Cancer, run by Hoffmann-La Roche at 8 sites in 5 countries.
Trial summary
This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- RO7051790
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 20 Dec 2016to 24 Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life expectancy greater than or equal to (>=) 12 weeks
- Participants must have histologically or cytologically confirmed diagnosis of SCLC
- Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
- Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1
- Measureable disease per RECIST v1.1 prior to administration of study medication
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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- Adequate bone marrow function
- Adequate renal function
- Participant must be able to swallow and retain orally administered study treatment
- Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for a period of time after the last dose of study treatment
Who cannot join
- Active malignancy other than SCLC within the previous 5 years
- Participants who have received radiotherapy less than 2 weeks prior to first dose of study medication
- Surgical procedure or clinically significant trauma within 2 weeks of first dose of study treatment
- Treatment with any investigational agent <=3 weeks prior to first dose of study treatment
- Participants with gastrectomy or pre-existing gastrointestinal disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator
- Participants medicated with anti-depressants reported to have lysine-specific histone demethylase 1A (KDM1A)/lysine (K)-specific demethylase 1A (LSD1) inhibitory activity (such as tranylcypromine or phenelzine) within 28 days of treatment start
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- History of allergic reactions attributed to components of the formulated product(s)
- History of seizure disorders
- Participants with untreated central nervous system metastases, or history of previously treated disease. Participants must have stable hematological parameters, satisfying eligibility, platelet count must be stable for >=2 weeks prior to study drug administration
- Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Participants with evidence of electrolyte imbalance
- Participants who are pregnant or breastfeeding
- Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
- Participants with known bone marrow disorders which may interfere with bone marrow recovery or participants with delayed recovery from prior chemoradiotherapy
- Participants with known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
- Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)-positive participants with active infection
- Use of strong Cytochrome P450 3A4 (CYP3A4) inducers while on study medication
- Participants with abnormal hepatic function
- Participants with history of clinically significant bleeding, specifically any history of intracranial hemorrhage/hemorrhagic cardiovascular accident (CVA), or participants with gastrointestinal bleeding within the 12 months prior to study entry
- Participants receiving therapeutic anti-coagulation or anti-platelet (anti-aggregant) therapies, except for therapeutic enoxaparin or low dose aspirin. Use of subcutaneous heparin prophylaxis, including low molecular weight heparin is also permitted
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Spain3 sites
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, 28050
Canada2 sites
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: A Multi-Center, Open Label, Phase I, Dose Finding and Expansion Study of RO7051790 Administered Orally in Patients With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)
This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.
- Conditions
- Small Cell Lung Cancer
- Being tested
- RO7051790
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7051790Drug
RO7051790 will be given orally. Treatment will be continued until disease progression/treatment failure, unacceptable toxicity, or study discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Introductory Cohort - 400 μg RO7051790 | Experimental | Introductory cohort to ensure participant safety, prior to the dose escalation study. 400 μg of RO7051790 was administered to two (2) participants followed by a 21-day DLT observation period. Receives: Drug: RO7051790 |
| Dose Escalation - 1000 μg RO7051790 | Experimental | 1000 μg of RO7051790 was administered to six (6) participants once every 3 weeks (Q3W). Receives: Drug: RO7051790 |
| Dose Escalation - 1300 μg RO7051790 | Experimental | 1300 μg of RO7051790 was administered to seven (7) participants once every 3 weeks (Q3W). Receives: Drug: RO7051790 |
| Dose Escalation - 1900 μg RO7051790 | Experimental | 1900 μg of RO7051790 was administered to three (3) participants once every 3 weeks (Q3W). Receives: Drug: RO7051790 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: Baseline up to approximately 18 weeks
Number of Participants with Dose-Limited Toxicities (DLTs)
DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. DLTs were at least possibly related to RO7051790 and had to meet any one of the following criteria: Grade≥4 neutropenia lasting >7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade≥4 anemia; Febrile neutropenia; Grade≥3 elevation in serum hepatic transaminase lasting >7 days; Grade≥3 elevation of serum bilirubin; and Grade≥3 non-hematologic, non-hepatic adverse event (with few exceptions).
Measured: First treatment cycle (21 days)
Secondary outcomes (14)
Percentage of Participants with Best Confirmed Overall Response
Best Confirmed Overall Response was evaluated according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Complete Response (CR) included the disappearance of all target lesions; Partial Response (PR) was at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) was at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD) was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (Assessed every 6 weeks up to approximately 18 weeks)
Percentage of Participants with Objective Response According to RECIST
Objective response was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.
Measured: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Duration of Response According to RECIST v1.1
Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier.
Measured: Time from first occurrence of a documented objective response to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Progression-Free Survival (PFS) According to RECIST v1.1
Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using RECIST or death from any cause, whichever occurred first.
Measured: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Overall Survival (OS)
Measured: Time from first study treatment to death from any cause (up to approximately 12 months)
Maximum Observed Plasma Concentration (Cmax) of RO7051790
Measured: Predose (0 hours [hrs]) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1,2,4,6,8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8,12,15,19
Minimum Observed Plasma Trough Concentration (Cmin) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Plasma Decay Half-Life (t1/2) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Apparent Oral Clearance (CL/F) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Apparent Volume of Distribution (Vz/F) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Accumulation Ratio (RA) of RO7051790
Measured: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start20 Dec 2016
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT02913443
- Sponsor's protocol ID
- NP39148
- Other IDs
- 2016-001942-25, 2016
- Status last verified
- Oct 2018
- First submitted
- 16 Sep 2016
- Last updated
- 19 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Phase I, Dose Finding and Expansion Study of RO7051790 Administered Orally in Patients With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)
- ClinicalTrials.gov ID
- NCT02913443
- Acronym / sponsor ID
- NP39148
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 23 Sep 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 I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Introductory Cohort - 400 μg RO7051790 | Experimental | Drug: RO7051790Introductory cohort to ensure participant safety, prior to the dose escalation study. 400 μg of RO7051790 was administered to two (2) participants followed by a 21-day DLT observation period. |
| Dose Escalation - 1000 μg RO7051790 | Experimental | Drug: RO70517901000 μg of RO7051790 was administered to six (6) participants once every 3 weeks (Q3W). |
| Dose Escalation - 1300 μg RO7051790 | Experimental | Drug: RO70517901300 μg of RO7051790 was administered to seven (7) participants once every 3 weeks (Q3W). |
| Dose Escalation - 1900 μg RO7051790 | Experimental | Drug: RO70517901900 μg of RO7051790 was administered to three (3) participants once every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Life expectancy greater than or equal to (>=) 12 weeks
- Participants must have histologically or cytologically confirmed diagnosis of SCLC
- Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
- Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1
- Measureable disease per RECIST v1.1 prior to administration of study medication
Key exclusion criteria (20 listed)
- Active malignancy other than SCLC within the previous 5 years
- Participants who have received radiotherapy less than 2 weeks prior to first dose of study medication
- Surgical procedure or clinically significant trauma within 2 weeks of first dose of study treatment
- Treatment with any investigational agent <=3 weeks prior to first dose of study treatment
- Participants with gastrectomy or pre-existing gastrointestinal disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator
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 |
|---|---|---|
| RO7051790RO7051790 will be given orally. Treatment will be continued until disease progression/treatment failure, unacceptable toxicity, or study discontinuation. | Drug | Dose Escalation - 1000 μg RO7051790, Dose Escalation - 1300 μg RO7051790, Dose Escalation - 1900 μg RO7051790, Introductory Cohort - 400 μg RO7051790 |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 18 weeks
Number of Participants with Dose-Limited Toxicities (DLTs)
Time frame: First treatment cycle (21 days)
DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. DLTs were at least possibly related to RO7051790 and had to meet any one of the following criteria: Grade≥4 neutropenia lasting >7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade≥4 anemia; Febrile neutropenia; Grade≥3 elevation in serum hepatic transaminase lasting >7 days; Grade≥3 elevation of serum bilirubin; and Grade≥3 non-hematologic, non-hepatic adverse event (with few exceptions).
14 secondary outcomes
Percentage of Participants with Best Confirmed Overall Response
Time frame: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (Assessed every 6 weeks up to approximately 18 weeks)
Percentage of Participants with Objective Response According to RECIST
Time frame: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Duration of Response According to RECIST v1.1
Time frame: Time from first occurrence of a documented objective response to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Progression-Free Survival (PFS) According to RECIST v1.1
Time frame: Time from first study treatment to the time of progression or death from any cause, whichever occurs first (assessed every 6 weeks up to approximately 18 weeks)
Overall Survival (OS)
Time frame: Time from first study treatment to death from any cause (up to approximately 12 months)
Maximum Observed Plasma Concentration (Cmax) of RO7051790
Time frame: Predose (0 hours [hrs]) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1,2,4,6,8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8,12,15,19
Minimum Observed Plasma Trough Concentration (Cmin) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Plasma Decay Half-Life (t1/2) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Apparent Oral Clearance (CL/F) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Apparent Volume of Distribution (Vz/F) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
Accumulation Ratio (RA) of RO7051790
Time frame: Predose (0 hrs) on Day 1 of every cycle until end of treatment (up to 18 weeks, each cycle is 21 days); Cycles 1 and 2: 1, 2, 4, 6, 8 (only in Cycle 1) hrs postdose on Day 1 and on Days 2 (only in Cycle 1), 4, 5 (only in Cycle 1), 8, 12, 15, 19
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 19 Oct 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.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7051790 in people with Small Cell Lung Cancer, run by Hoffmann-La Roche at 8 sites in 5 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 10 inclusion and 20 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Canada, United States, Denmark, 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 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 Adverse Events (time frame: Baseline up to approximately 18 weeks). The study lists 2 primary outcomes in all. 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 19 Oct 2018.