MyelomaPhase 2NCT02188537
Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma
A Phase 2 study testing Nelfinavir, bortezomib and Dexamethasone in people with Myeloma, run by Swiss Cancer Institute at 12 sites in Switzerland.
Trial summary
Trial objectives: To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Nelfinavir, bortezomib and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 12 sitesSwitzerland
- Study dates
- 2 Dec 2014to 17 Apr 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
- Patient must give written informed consent prior to any protocol-specific procedure.
- Patient was diagnosed with multiple myeloma based on standard IMWG criteria, and has received at least one previous line of chemotherapy.
- Patient has been exposed to or is intolerant to at least one IMID (thalidomide, lenalidomide, pomalidomide).
- A therapy with bortezomib in the approved dose and schedule, based on Swissmedic approval (treatment of patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy), is indicated and intended.
- Patient is refractory to his/her most recent proteasome inhibitor-containing regimen, based on divers criteria.
- WHO performance status ≤ 3.
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- Age ≥ 18 years.
- Adequate hematological values: platelets ≥ 50 x 109/L, hemoglobin ≥ 80 g/L (both may be achieved by transfusion).
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN (for patients with suspected hemolysis: direct bilirubin ≤ 1.5 x ULN), ALT ≤ 3 x ULN (≤ 5 x ULN if liver infiltration by myeloma suspected, based on imaging results).
- Calculated creatinine clearance ≥ 15 mL/min, according to the formula of Cockcroft-Gault, see Appendix 1).
- Women are not breastfeeding. Women with child-bearing potential are using effective contraception (see 9.8), are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 12 months thereafter.
- Completed baseline QoL questionnaire.
Who cannot join
- Evidence of ongoing uncontrolled systemic infections.
- History of chronic active HCV or HBV.
- Evidence of myeloma within the CNS.
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out quality of life (QoL) forms, or interfering with compliance for oral drug intake.
- Exposure to another experimental drug within 3 weeks prior to trial entry.
- Any serious underlying medical condition (at the judgment of the investigator) which may impair the ability of the patient to participate in the trial, in particular any uncontrolled clinically significant active disease (e.g. active autoimmune disease, uncontrolled diabetes, uncontrolled cardiac disease).
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- Non-hematologic active malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas.
- Concomitant use of other anti-cancer medication or radiotherapy except for local pain control. The use of bisphosphonates is allowed.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
- Known hypersensitivity to bortezomib or nelfinavir or hypersensitivity to components of these drugs.
- Any psychological, familial, sociological or geographical condition likely hampering compliance with the trial protocol and follow-up.
- Patient who takes the following drugs during the trial therapy, which cannot be replaced or paused.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Kantonsspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, 5404
Universitaetsspital-Basel
Basel, CH-4031
Istituto Oncologico Svizzera Italiana IOSI
Bellinzona, 6500
Inselspital Bern
Bern, 3010
Kantonsspital Graubuenden
Chur, CH-7000
Hopital Fribourgeois
Fribourg, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma. A Multicenter Phase II Trial
Trial objectives:
To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.
Additional research questions:
To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.
Read the detailed description
Trial objectives:
To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.
Additional research questions:
To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.
Primary endpoint:
Response rate based on best response observed during the trial
Selection of patients:
- Patients with multiple myeloma based on standard IMWG criteria, who have received at least one prior line of chemotherapy
- Previously exposed to or intolerant to at least one immunomodulatory drug (IMID) (thalidomide, lenalidomide, pomalidomide)
- Refractory to their most recent proteasome inhibitor-containing regimen or progressed during or within 60 days after proteasome inhibitor-containing therapy
- A bortezomib-based therapy in agreement with Swissmedic approval is indicated and intended
- Measurable disease based on serum paraprotein or free light chain levels
- Adequate hematological, hepatic and renal functions
- Absence of myeloma within the CNS
- No significant neuropathy
- No concomitant use of listed drugs which cannot be replaced or paused during trial treatment (Amiodarone, Pimozide, quinidine and its derivatives, ergot derivatives (dihydroergotamine, ergotamine, ergonovine, methylergonovine), triazolam, midazolam, sildenafil, alfuzosin)
Trial Schedule and Duration:
The inclusion of patients is planned to start in Q3 2014 and will stop after the inclusion of 34 evaluable patients, which is expected in Q1 2016. End of trial treatment is expected for Q3 2016. Trial termination (last patient last visit) is expected to be in 2017.
Accrual may be interrupted or the trial may be stopped early based on the results of an interim analysis or if new scientific data become available which change assessment of risk/benefit.
Trial product:
For this trial nelfinavir is the IMP. Bortezomib (Velcade®) and dexamethasone are not investigational drugs in the context of this trial, but will be administered as a background medication.
Trial Treatment:
The trial treatment is designed as an "add-on" therapy, where nelfinavir is added to the approved bortezomib therapy. Bortezomib and dexamethasone background treatment will be given in the approved dose and schedule (either i.v. or s.c), as per Swissmedic label and international therapeutic standard, in combination with 2500 mg Nelfinavir bid p.o. day 1-14 for 6 cycles of 21 days.
Measurements and procedures:
Before the trial treatment Clinical examination; blood analyses; imaging investigations if applicable (e.g. bone X-ray or computer tomography, MRI); electrocardiogram; evaluation of the quality of life with a patient's questionnaire; pregnancy test for women in child-bearing age; optional: a bone marrow sample is taken for translational research. Aside from the electrocardiogram, the pregnancy test and the quality of life questionnaire, all the pre-treatment assessments performed within the frame of the trial are also routinely performed for the medical care of patients with multiple myeloma outside of a trial.
During the trial treatment Clinical examination and blood analyses for the control of safety laboratory parameters; evaluation of the quality of life with a patient's questionnaire will be performed after completion of 3 cycles of therapy. Besides the quality of life questionnaire, all assessments would also be performed routinely outside of the trial.
After the trial treatment Clinical examination and blood analyses for the control of safety laboratory parameters; these investigations will be performed within 1 month after treatment end, premature interruption or before the administration of a new antimyeloma therapy. These assessments are routinely done also outside of the trial.
Statistical Considerations:
The Simon's two-stage design will be used. A response rate of 15% or less is considered uninteresting and 35% or higher is promising. The trial will be stopped early if the treatment appears unpromising at the end of the first stage. To allow patient accrual while waiting for the stage-1 results, the design is modified according to Herndon's approach.
With a significance level of 5% and a power of 80%, a total of 34 patients are required with 10 patients in the first stage and 24 patients in the second stage.
- Conditions
- Myeloma
- Being tested
- Nelfinavir, bortezomib, Dexamethasone
- Keywords
- Myeloma, proteasome inhibitor-nonresponsive myeloma, Nelfinavir, bortezomib, bortezomib-sensitizing drug
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
Also called Viracept
Nelfinavir 2x 2500 mg p.o. days 1 - 14
bortezomibDrug
Also called Velcade®
Bortezomib 1.3 mg/m2 i.v. or s.c. days 1, 4, 8, 11
DexamethasoneDrug
Dexamethasone 20 mg p.o. days 1-2, 4-5, 8-9, 11-12
| Study group | Role | What they receive |
|---|---|---|
| Nelfinavir, Bortezomib, Dexamethasone | Experimental | The trial is designed as an "add-on" therapy, where nelfinavir is added to the approved bortezomib-containing therapy. Bortezomib and dexamethasone background treatment will be given in the Swissmedic-approved dose and schedule and according to international therapeutic standard. Receives: Drug: Nelfinavir; Drug: bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate based on best response observed during the trial
Measured: end of cycle 6 (at week 19)
Secondary outcomes (6)
Adverse events
Measured: end of cycle 6 (at week 19)
Proportion of patients achieving at least a minor response
Measured: end of cycle 6 (at week 19)
Disease control rate (no evidence of disease progression for at least 3 cycles)
Measured: end of cycle 6 (at week 19)
Time from registration to the start of the next new antimyeloma therapy or death from any cause
Measured: end of cycle 6 (at week 19)
Progressive disease under trial treatment
Measured: end of cycle 6 (at week 19)
Quality of life
Measured: day 1 of cycle 4 (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start2 Dec 2014
- Primary completion26 Jul 2016
- Study completion17 Apr 2018
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 MyelomaStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Driessen, Prof MD, Study chair, Cantonal Hospital of St. GallenPanagiotis Samaras, MD, Study chair, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188537
- Sponsor's protocol ID
- SAKK 39/13 - FORTUNE
- Other IDs
- SNCTP000001061
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2014
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Driessen C, Muller R, Novak U, Cantoni N, Betticher D, Mach N, Rufer A, Mey U, Samaras P, Ribi K, Besse L, Besse A, Berset C, Rondeau S, Hawle H, Hitz F, Pabst T, Zander T. Promising activity of nelfinavir-bortezomib-dexamethasone in proteasome inhibitor-refractory multiple myeloma. Blood. 2018 Nov 8;132(19):2097-2100. doi: 10.1182/blood-2018-05-851170. Epub 2018 Sep 20. No abstract available.
PubMed 30237154
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma. A Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT02188537
- Acronym / sponsor ID
- SAKK 39/13 - FORTUNE
- Conditions
- Myeloma
- Keywords
- Myeloma, proteasome inhibitor-nonresponsive myeloma, Nelfinavir, bortezomib, bortezomib-sensitizing drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 11 Jul 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.
Trial objectives:
To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.
Additional research questions:
To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.
Detailed description
Trial objectives:
To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.
Additional research questions:
To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.
Primary endpoint:
Response rate based on best response observed during the trial
Selection of patients:
- Patients with multiple myeloma based on standard IMWG criteria, who have received at least one prior line of chemotherapy
- Previously exposed to or intolerant to at least one immunomodulatory drug (IMID) (thalidomide, lenalidomide, pomalidomide)
- Refractory to their most recent proteasome inhibitor-containing regimen or progressed during or within 60 days after proteasome inhibitor-containing therapy
- A bortezomib-based therapy in agreement with Swissmedic approval is indicated and intended
- Measurable disease based on serum paraprotein or free light chain levels
- Adequate hematological, hepatic and renal functions
- Absence of myeloma within the CNS
- No significant neuropathy
- No concomitant use of listed drugs which cannot be replaced or paused during trial treatment (Amiodarone, Pimozide, quinidine and its derivatives, ergot derivatives (dihydroergotamine, ergotamine, ergonovine, methylergonovine), triazolam, midazolam, sildenafil, alfuzosin)
Trial Schedule and Duration:
The inclusion of patients is planned to start in Q3 2014 and will stop after the inclusion of 34 evaluable patients, which is expected in Q1 2016. End of trial treatment is expected for Q3 2016. Trial termination (last patient last visit) is expected to be in 2017.
Accrual may be interrupted or the trial may be stopped early based on the results of an interim analysis or if new scientific data become available which change assessment of risk/benefit.
Trial product:
For this trial nelfinavir is the IMP. Bortezomib (Velcade®) and dexamethasone are not investigational drugs in the context of this trial, but will be administered as a background medication.
Trial Treatment:
The trial treatment is designed as an "add-on" therapy, where nelfinavir is added to the approved bortezomib therapy. Bortezomib and dexamethasone background treatment will be given in the approved dose and schedule (either i.v. or s.c), as per Swissmedic label and international therapeutic standard, in combination with 2500 mg Nelfinavir bid p.o. day 1-14 for 6 cycles of 21 days.
Measurements and procedures:
Before the trial treatment Clinical examination; blood analyses; imaging investigations if applicable (e.g. bone X-ray or computer tomography, MRI); electrocardiogram; evaluation of the quality of life with a patient's questionnaire; pregnancy test for women in child-bearing age; optional: a bone marrow sample is taken for translational research. Aside from the electrocardiogram, the pregnancy test and the quality of life questionnaire, all the pre-treatment assessments performed within the frame of the trial are also routinely performed for the medical care of patients with multiple myeloma outside of a trial.
During the trial treatment Clinical examination and blood analyses for the control of safety laboratory parameters; evaluation of the quality of life with a patient's questionnaire will be performed after completion of 3 cycles of therapy. Besides the quality of life questionnaire, all assessments would also be performed routinely outside of the trial.
After the trial treatment Clinical examination and blood analyses for the control of safety laboratory parameters; these investigations will be performed within 1 month after treatment end, premature interruption or before the administration of a new antimyeloma therapy. These assessments are routinely done also outside of the trial.
Statistical Considerations:
The Simon's two-stage design will be used. A response rate of 15% or less is considered uninteresting and 35% or higher is promising. The trial will be stopped early if the treatment appears unpromising at the end of the first stage. To allow patient accrual while waiting for the stage-1 results, the design is modified according to Herndon's approach.
With a significance level of 5% and a power of 80%, a total of 34 patients are required with 10 patients in the first stage and 24 patients in the second stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelfinavir, Bortezomib, Dexamethasone | Experimental | Drug: Nelfinavir, Drug: bortezomib, Drug: DexamethasoneThe trial is designed as an "add-on" therapy, where nelfinavir is added to the approved bortezomib-containing therapy. Bortezomib and dexamethasone background treatment will be given in the Swissmedic-approved dose and schedule and according to international therapeutic standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient must give written informed consent prior to any protocol-specific procedure.
- Patient was diagnosed with multiple myeloma based on standard IMWG criteria, and has received at least one previous line of chemotherapy.
- Patient has been exposed to or is intolerant to at least one IMID (thalidomide, lenalidomide, pomalidomide).
- A therapy with bortezomib in the approved dose and schedule, based on Swissmedic approval (treatment of patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy), is indicated and intended.
- Patient is refractory to his/her most recent proteasome inhibitor-containing regimen, based on divers criteria.
Key exclusion criteria (12 listed)
- Evidence of ongoing uncontrolled systemic infections.
- History of chronic active HCV or HBV.
- Evidence of myeloma within the CNS.
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out quality of life (QoL) forms, or interfering with compliance for oral drug intake.
- Exposure to another experimental drug within 3 weeks prior to trial entry.
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 |
|---|---|---|
| NelfinavirAlso: ViraceptNelfinavir 2x 2500 mg p.o. days 1 - 14 | Drug | Nelfinavir, Bortezomib, Dexamethasone |
| bortezomibAlso: Velcade®Bortezomib 1.3 mg/m2 i.v. or s.c. days 1, 4, 8, 11 | Drug | Nelfinavir, Bortezomib, Dexamethasone |
| DexamethasoneDexamethasone 20 mg p.o. days 1-2, 4-5, 8-9, 11-12 | Drug | Nelfinavir, Bortezomib, Dexamethasone |
Primary outcome
Response rate based on best response observed during the trial
Time frame: end of cycle 6 (at week 19)
6 secondary outcomes
Adverse events
Time frame: end of cycle 6 (at week 19)
Proportion of patients achieving at least a minor response
Time frame: end of cycle 6 (at week 19)
Disease control rate (no evidence of disease progression for at least 3 cycles)
Time frame: end of cycle 6 (at week 19)
Time from registration to the start of the next new antimyeloma therapy or death from any cause
Time frame: end of cycle 6 (at week 19)
Progressive disease under trial treatment
Time frame: end of cycle 6 (at week 19)
Quality of life
Time frame: day 1 of cycle 4 (week 10)
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 26 Jun 2019.
- Results publication: PubMed 30237154Driessen C, Muller R, Novak U, Cantoni N, Betticher D, Mach N, Rufer A, Mey U, Samaras P, Ribi K, Besse L, Besse A, Berset C, Rondeau S, Hawle H, Hitz F, Pabst T, Zander T. Promising activity of nelfinavir-bortezomib-dexamethasone in proteasome inhibitor-refractory multiple myeloma. Blood. 2018 Nov 8;132(19):2097-2100. doi: 10.1182/blood-2018-05-851170. Epub 2018 Sep 20. No abstract available.
- Individual participant dataSharing planned: No
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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.
Christoph Driessen, Prof MD study chair
Cantonal Hospital of St. Gallen
Panagiotis Samaras, MD study chair
Universitätsspital Zürich
12 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 Nelfinavir, bortezomib and Dexamethasone in people with Myeloma, run by Swiss Cancer Institute at 12 sites in Switzerland.
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 12 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. 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 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?
Response rate based on best response observed during the trial (time frame: end of cycle 6 (at week 19)). 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 NCT02188537, 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 26 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.