Urinary Bladder CancerPhase 1NCT02720367
Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer
A Phase 1 study testing Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 in people with Urinary Bladder Cancer, run by Taris Biomedical LLC at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2016to Mar 2020
- 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
- A documented history of histologically-confirmed low or intermediate risk urothelial carcinoma of the bladder, excluding carcinoma in situ (pTis), pathologic stage pT1 (invasive into lamina propria) and high-Grade disease, judged not to be muscle infiltrating (pT2 or greater) and accessible for resection.
- Adequate laboratory parameters.
- Screening urinalysis showing no clinically significant abnormalities except those attributable to bladder cancer.
- Not undergoing active treatment in last 3 months for prior or concurrent neoplastic disease and have fully recovered from treatment effects. Patients undergoing concurrent hormonal therapy treatment for prostate cancer will be allowed to enroll.
Who cannot join
- Exposure to BCG therapy and/or any other intravesical. chemotherapeutic agent less than 1 year prior to enrollment, except single postoperative instillations.
- Absence of visible tumor at Screening.
- Any previous exposure to intravesical gemcitabine instillations within the past 12 months.
- Presence of any bladder or urethral anatomical feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200 (i.e. bladder diverticula, complete incontinence).
- Patients with a high-Grade urine cytology at recurrence.
- Currently receiving other systemic or intravesical chemotherapy.
Show all 14Show fewer
- Pelvic radiotherapy administered within 6 months prior to enrollment. Patients who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no cystoscopic evidence or clinical symptoms of radiation cystitis.
- Bladder Post-Void Residual Volume (PVR) of > 250-mL.
- Active, uncontrolled urogenital bacterial, viral, or fungal infections, including urinary tract infection. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
- History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
- Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ≤5 mg daily.
- Female subject who is pregnant (as verified by urine test at time of screening) or lactating, or of childbearing potential and not using acceptable methods of contraception.
- Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.
- Other unspecified reasons that, in the opinion of the investigator or TARIS, make the patient unsuitable for enrollment.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Canisius Wilhelmina Ziekenhuis
Nijmegen
Radboudumc
Nijmegen
About this study
Official title: A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)
- Conditions
- Urinary Bladder Cancer
- Being tested
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200Drug
TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical system whose primary mode of action is the controlled release of gemcitabine into the bladder over an indwelling period.
| Study group | Role | What they receive |
|---|---|---|
| 7-Day Regimen | Experimental | TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 7. TAR-200 releases gemcitabine gradually during the 7 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 28, which is the day of the TURBT. Receives: Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 |
| 21-Day Regimen | Experimental | TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 21. TAR-200 releases gemcitabine gradually during the 21 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 42. Receives: Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
Measured: From the point of signing the informed consent form through last study visit, up to 59 days.
Secondary outcomes (34)
Number of participants who are tolerant of TAR-200 indwelling (Arm 1)
Measured: From Day 0 up to Day 7
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)
Measured: From Day 0 up to Day 7
Number of participants who are tolerant of TAR-200 indwelling (Arm 1)
Measured: From Day 21 up to Day 28
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)
Measured: From Day 21 up to Day 28
Cmax, plasma dFdU (Arm 1)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 32
Tmax, plasma dFdU (Arm 1)
Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 32
Cavg, plasma dFdU (Arm 1)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 32
Cmax, plasma dFdC (Arm 1)
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma.
Measured: From Day 0 up to Day 32
Tmax, plasma dFdC (Arm 1)
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma
Measured: From Day 0 up to Day 32
Cavg, plasma dFdC (Arm 1)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma.
Measured: From Day 0 up to Day 32
Cmax, urine dFdU (Arm 1)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine.
Measured: From Day 0 up to Day 32
Tmax, urine dFdU (Arm 1)
Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in urine
Measured: From Day 0 up to Day 32
Cavg, urine dFdU (Arm 1)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in urine.
Measured: From Day 0 up to Day 32
Cmax, urine dFdC (Arm 1)
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine.
Measured: From Day 0 up to Day 32
Tmax, urine dFdC (Arm 1)
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine.
Measured: From Day 0 up to Day 32
Cavg, urine dFdC (Arm 1)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine
Measured: From Day 0 up to Day 32
Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 1)
Measured: Anti-tumor analysis will occur at the following study day visit Day 28
Number of participants who are tolerant of TAR-200 indwelling (Arm 2)
Measured: From Day 0 up to Day 21
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2)
Measured: From Day 0 up to Day 21
Number of participants who are tolerant of TAR-200 indwelling (Arm 2)
Measured: From Day 21 up to Day 42
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2)
Measured: From Day 21 up to Day 42
Cmax, plasma dFdU (Arm 2)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 47
Tmax, plasma dFdU (Arm 2)
Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 47
Cavg, plasma dFdU (Arm 2)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 47
Cmax, plasma dFdC (Arm 2)
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma.
Measured: From Day 0 up to Day 47
Tmax, plasma dFdC (Arm 2)
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma
Measured: From Day 0 up to Day 47
Cavg, plasma dFdC (Arm 2)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma.
Measured: From Day 0 up to Day 47
Cmax, urine dFdU (Arm 2)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine.
Measured: From Day 0 up to Day 47
Tmax, urine dFdU (Arm 2)
Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in urine
Measured: From Day 0 up to Day 47
Cavg, urine dFdU (Arm 2)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in urine.
Measured: From Day 0 up to Day 47
Cmax, urine dFdC (Arm 2)
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine.
Measured: From Day 0 up to Day 47
Tmax, urine dFdC (Arm 2)
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine.
Measured: From Day 0 up to Day 47
Cavg, urine dFdC (Arm 2)
Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine
Measured: From Day 0 up to Day 47
Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 2)
Measured: Anti-tumor analysis will occur at the following study day visit Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taris Biomedical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Witjes, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720367
- Sponsor's protocol ID
- TAR-200-102
- Other IDs
- 2016-000099-66, 2016
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2016
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT02720367
- Acronym / sponsor ID
- TAR-200-102
- Conditions
- Urinary Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Taris Biomedical LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 25 Mar 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.
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-Day Regimen | Experimental | Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 7. TAR-200 releases gemcitabine gradually during the 7 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 28, which is the day of the TURBT. |
| 21-Day Regimen | Experimental | Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 21. TAR-200 releases gemcitabine gradually during the 21 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 42. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A documented history of histologically-confirmed low or intermediate risk urothelial carcinoma of the bladder, excluding carcinoma in situ (pTis), pathologic stage pT1 (invasive into lamina propria) and high-Grade disease, judged not to be muscle infiltrating (pT2 or greater) and accessible for resection.
- Adequate laboratory parameters.
- Screening urinalysis showing no clinically significant abnormalities except those attributable to bladder cancer.
- Not undergoing active treatment in last 3 months for prior or concurrent neoplastic disease and have fully recovered from treatment effects. Patients undergoing concurrent hormonal therapy treatment for prostate cancer will be allowed to enroll.
Key exclusion criteria (14 listed)
- Exposure to BCG therapy and/or any other intravesical. chemotherapeutic agent less than 1 year prior to enrollment, except single postoperative instillations.
- Absence of visible tumor at Screening.
- Any previous exposure to intravesical gemcitabine instillations within the past 12 months.
- Presence of any bladder or urethral anatomical feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200 (i.e. bladder diverticula, complete incontinence).
- Patients with a high-Grade urine cytology at recurrence.
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 |
|---|---|---|
| Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical system whose primary mode of action is the controlled release of gemcitabine into the bladder over an indwelling period. | Drug | 21-Day Regimen, 7-Day Regimen |
Primary outcome
Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
Time frame: From the point of signing the informed consent form through last study visit, up to 59 days.
34 secondary outcomes
Number of participants who are tolerant of TAR-200 indwelling (Arm 1)
Time frame: From Day 0 up to Day 7
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)
Time frame: From Day 0 up to Day 7
Number of participants who are tolerant of TAR-200 indwelling (Arm 1)
Time frame: From Day 21 up to Day 28
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)
Time frame: From Day 21 up to Day 28
Cmax, plasma dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Tmax, plasma dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Cavg, plasma dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Cmax, plasma dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Tmax, plasma dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Cavg, plasma dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Cmax, urine dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Tmax, urine dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Cavg, urine dFdU (Arm 1)
Time frame: From Day 0 up to Day 32
Cmax, urine dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Tmax, urine dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Cavg, urine dFdC (Arm 1)
Time frame: From Day 0 up to Day 32
Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 1)
Time frame: Anti-tumor analysis will occur at the following study day visit Day 28
Number of participants who are tolerant of TAR-200 indwelling (Arm 2)
Time frame: From Day 0 up to Day 21
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2)
Time frame: From Day 0 up to Day 21
Number of participants who are tolerant of TAR-200 indwelling (Arm 2)
Time frame: From Day 21 up to Day 42
Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2)
Time frame: From Day 21 up to Day 42
Cmax, plasma dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Tmax, plasma dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Cavg, plasma dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Cmax, plasma dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Tmax, plasma dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Cavg, plasma dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Cmax, urine dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Tmax, urine dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Cavg, urine dFdU (Arm 2)
Time frame: From Day 0 up to Day 47
Cmax, urine dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Tmax, urine dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Cavg, urine dFdC (Arm 2)
Time frame: From Day 0 up to Day 47
Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 2)
Time frame: Anti-tumor analysis will occur at the following study day visit Day 42
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 10 Mar 2020.
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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.
Johannes Witjes, MD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 in people with Urinary Bladder Cancer, run by Taris Biomedical LLC at 2 sites in Netherlands.
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 4 inclusion and 14 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0 (time frame: From the point of signing the informed consent form through last study visit, up to 59 days.). 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 10 Mar 2020.