Prostate CancerPhase 2NCT03356912
CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer Progressed During or After a Previous Docetaxel-based Chemotherapy
A Phase 2 study testing Cabazitaxel and Prednisone in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Consorzio Oncotech at 1 site in Italy.
Trial summary
Patients with metastatic castration resistant prostate cancer (mCRPC) progressed during or after a previous docetaxel-based chemotherapy, for whom cabazitaxel has been scheduled as per clinical practice and label indication. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- Cabazitaxel and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2017to 4 May 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Histological diagnosis of prostate adenocarcinoma;
- Metastatic castration-resistant disease with documented radiographic progression (osseous or measurable lesions) during or after a docetaxel-based chemotherapy;
- Testosterone level in the castration range (levels <50 ng/dl) because of a previous, and ongoing, androgen deprivation with LH-RH agonists or antagonists or bilateral orchiectomy;
- Prior surgery and/or radiation therapy (to less or equal than 30% of the bone marrow) are allowed. However, at least 4 weeks must have been elapsed since surgery or completion of radiation therapy and the patient must has recovered from side effects;
- Life expectancy ≥ 3 months;
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- Age > 18 years;
- ECOG performance status 0-2;
- ANC ≥ 1.5 x 109/L;
- PLT ≥ 100 x 109/L;
- Hb ≥ 10 g/dl;
- Serum total bilirubin ≤ UNL;
- AST/SGOT and/or ALT/SGPT ≤1,5 x ULN;
- Serum Creatinine ≤1,5 times UNL (in case of limit values of serum creatinine, creatinine clearance calculated by CKD-EPI formula should be ≥60 ml/min);
- PT or INR and PTT <1,5 times UNL (Note: patients who receive anti-coagulation treatment will be allowed to participate provided that any abnormality in these parameters exists);
- Patients must be accessible for treatment and follow up;
Who cannot join
- Participation in clinical trials with other investigational drug within 28 days of study entry;
- Symptomatic or uncontrolled brain metastases. Patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis; previously treated brain metastases will be allowed as long as the patient is neurologically stable and does not require steroids and anticonvulsants;
- Less than 4 weeks elapsed from prior anticancer-therapy or surgery to the time of randomization. Prior treatment with abiraterone or enzalutamide is allowed and is used as a stratification factor at randomization. Patient may be on biphosphonates prior to study entry;
- Less than 4 weeks from palliative Radiotherapy to time of randomization;
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, pulmonary embolism or other uncontrolled thromboembolic event;
- Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures;
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- Unstable diabetes mellitus, resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, acute diverticulitis or other contraindications to use of corticosteroid treatment;
- Peripheral neuropathy Grade > 2 (National Cancer Institute Common Terminology Criteria (NCI CTCAE v.4.03);
- Previous beta or gamma Isotope treatment (e.g. strontium or samarium), alpha emitters are allowed;
- History of severe hypersensitivity reaction (> grade 2) to polysorbate 80 containing drugs;
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week washout period is necessary for patients who are already on these treatments);
- Previous malignancy except for basal cell or squamous cell skin cancer adequately treated, or any other cancer from which the patient has been disease-free for ≥ 5 years;
- Patients with reproductive potential who do not agree to use accepted and effective method of contraception, based on the investigator's judgment, during the study treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer (mCRPC) Progressed During or After a Previous Docetaxel-based Chemotherapy:a Multi-center,Prospective,Two-arm, Open Label, Non Inferiority Phase II Study
Patients with metastatic castration resistant prostate cancer (mCRPC) progressed during or after a previous docetaxel-based chemotherapy, for whom cabazitaxel has been scheduled as per clinical practice and label indication.
In the "TROPIC" Trial, cabazitaxel, administered concomitantly with prednisone 10 mg daily, showed a significant advantage vs. mitoxantrone in both Overall Survival (OS) and Progression Free Survival (PFS) / radiographic PFS in patients failing docetaxel-based chemotherapy. Similar to docetaxel, cabazitaxel has been approved in combination with daily prednisone, but the benefits of adding daily corticosteroids to taxane chemotherapy remain to be proven. In fact, corticosteroids have a variety of biological effects, and a number of studies in large cohorts of patients show that they may have both favourable effects, mediated by adrenal androgen and cytokine suppression, and detrimental effects related to their adverse events associated with their long-term use as well to the potential promiscuous activation of the AR. In fact, prednisone and dexamethasone can activate some AR variants that make tumors sensitive to glucocorticoids even at low concentrations. It has been showed that point mutations of the AR, which appear to cluster in the ligand-binding domain, are rare in therapy naive patients but occur in 15- 45% of patients with castration-resistant disease and can increase AR affinity for a wide range of steroids. On the other hand, insofar as safety is concerned, omitting daily corticosteroids does not seem to increase toxicity (e.g. hypersensitivity reactions). In fact, in the CHARTEED trial, docetaxel was safely administered without daily corticosteroids. Safety data about the use of cabazitaxel without daily prednisone/prednisone alone are missing.
The CABACARE study is designed to assess the effects in terms of efficacy, safety as well as quality of life of omitting daily corticosteroids in patients treated with cabazitaxel. Furthermore, the CABACARE study evaluates the mutational status of the RB gene as well as presence of AR-V7 variant. The AR-V7 status assessed in circulating tumor cells has a strong predictive value for abiraterone/enzalutamide effectiveness, but its role in patients receiving cabazitaxel requires to be defined.
Read the detailed description
Patients will be randomly assigned (1:1) to receive either:
Arm A Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, plus prednisone 10 mg orally given daily. Premedication must be administered according to Cabazitaxel Package Insert.
Arm B Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, without daily prednisone. Premedication must be administered according to Cabazitaxel Package Insert.
Each patient will be treated until radiological disease progression, unacceptable toxicity, or patient refusal. Patients will be followed through subsequent therapy lines of treatments until death or the study cut-off, whichever comes first.
Every effort will be made to administer the full dose regimen to maximize dose-intensity.
Dose reduction and/or treatment delay and/or treatment discontinuation are planned in case of severe toxicity. If toxicity occurs, dose of Cabazitaxel can be reduced to 20 mg/mq in both arms. If a second dose reduction is required the patient should be withdrawn from study.
Prednisone doses should not be delayed or modified or stopped (unless there is a contraindication to continue, the decision will be let to the investigator's discretion).
In case a dose reduction is required, cabazitaxel dose cannot be re-escalated. Prophylactic use of G-CSF is allowed, as per EORTC / ASCO guidelines and according to physician judgment. Patients experiencing neutropenia G 3-4 have to receive G-CSF in prophylaxis in subsequent cycles.
Primary Objective(s)
To evaluate whether cabazitaxel alone is non inferior in terms of radiographic PFS with respect to cabazitaxel plus daily prednisone in patients with castration resistant prostate cancer
Secondary Objective(s)
Safety in the two treatment arms; Health-Related Quality of Life (HRQL) and pain; Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Biochemical response (assessed considering PSA decrease ≥50% and waterfall plot results); Time to PSA Progression (TTPP); Radiographic Time to Progression (rTTP); Overall Survival (OS); Association of Overall
l Survival (OS), Progression Free Survival (PFS) and Objective Response Rate (ORR) with AR-V7 and RB status in circulating tumor cells assessed at flow-cytometry; Time to Skeletal-Related Event (SRE);
Primary end Point
Radiographic Progression-Free Survival (rPFS).
Secondary end points
Safety in the two treatment arms; Health-Related Quality of Life HRQL and pain; Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Biochemical response (PSA decrease ≥50%, waterfall plot); Time to PSA Progression (TTPP); Radiographic Time To Progression (rTTP); Overall Survival (OS); Association of Overall Survival (OS), Progression Free Survival (PFS) and Objective Response Rate (ORR) with AR-V7 and RB status in circulating tumor cells by the use of a DNA test; Time to Skeletal-Related Event (SRE).
- Being tested
- Cabazitaxel, Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Cabazitaxel drug products should be administered only by intravenous route.
Prednison should be administered by oral route
PrednisoneDrug
Prednisone should be administred by oral route
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel plus prednisone | Active comparator | Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, plus prednisone 10 mg orally given daily. Premedication must be administered according to Cabazitaxel Package Insert. Receives: Drug: Cabazitaxel; Drug: Prednisone |
| Cabazitaxel | Experimental | Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Premedication must be administered according to Cabazitaxel Package Insert. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Baseline radiographic progression
Radiographic progression evaluated by RECIST 1.1 criteria with bone scan, chest abdominal and pelvi TC MRI
Measured: From date of randomization until the date of first documented progression or but also during follow-up in case study treatment was discontinued without radiographic progression up to 48 months"
Secondary outcomes (4)
Health-Related Quality of Life and pain
Pain response will be calculated among patients with baseline median present pain intensity score (PPI) ≥2 on the McGill-Melzack scale and/or baseline mean analgesic score (AS) ≥10 points and with stable analgesia at baseline.
Measured: from the date of randomization and the date of either first documented pain progression or death due to any cause, whichever is earlier up to 48 months"
Adverse events
Incidence of Treatment-Emergent Adverse Events
Measured: From date of randomization until the date of first documented progression or but also during follow-up in case study treatment was discontinued up to 48 months" "
Health-Related Quality of Life
Functional Assessment of Cancer Therapy-Prostate" (FACT-P) questionnaire, version 4. The results is summed to give a score in the range of 0-156, where higher values represent better HRQL. Questionnaires will be self-administered and takes approximately 10 minutes to complete.
Measured: From date of screening until the date of first documented progression up to 48 months"
AR-V7 and RB status in circulating tumor cells
genetic blood evaluation
Measured: only at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start22 Nov 2017
- Primary completion4 May 2021 (estimated)
- Study completion4 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Giuseppe, MD, Principal investigator, Università Federico II Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356912
- Sponsor's protocol ID
- CABACARE
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer (mCRPC) Progressed During or After a Previous Docetaxel-based Chemotherapy:a Multi-center,Prospective,Two-arm, Open Label, Non Inferiority Phase II Study
- ClinicalTrials.gov ID
- NCT03356912
- Acronym / sponsor ID
- CABACARE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 4 May 2021 (estimated)
- Study completion
- 4 May 2021 (estimated)
- First posted
- 29 Nov 2017 (actual)
- 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.
Patients with metastatic castration resistant prostate cancer (mCRPC) progressed during or after a previous docetaxel-based chemotherapy, for whom cabazitaxel has been scheduled as per clinical practice and label indication.
In the "TROPIC" Trial, cabazitaxel, administered concomitantly with prednisone 10 mg daily, showed a significant advantage vs. mitoxantrone in both Overall Survival (OS) and Progression Free Survival (PFS) / radiographic PFS in patients failing docetaxel-based chemotherapy. Similar to docetaxel, cabazitaxel has been approved in combination with daily prednisone, but the benefits of adding daily corticosteroids to taxane chemotherapy remain to be proven. In fact, corticosteroids have a variety of biological effects, and a number of studies in large cohorts of patients show that they may have both favourable effects, mediated by adrenal androgen and cytokine suppression, and detrimental effects related to their adverse events associated with their long-term use as well to the potential promiscuous activation of the AR. In fact, prednisone and dexamethasone can activate some AR variants that make tumors sensitive to glucocorticoids even at low concentrations. It has been showed that point mutations of the AR, which appear to cluster in the ligand-binding domain, are rare in therapy naive patients but occur in 15- 45% of patients with castration-resistant disease and can increase AR affinity for a wide range of steroids. On the other hand, insofar as safety is concerned, omitting daily corticosteroids does not seem to increase toxicity (e.g. hypersensitivity reactions). In fact, in the CHARTEED trial, docetaxel was safely administered without daily corticosteroids. Safety data about the use of cabazitaxel without daily prednisone/prednisone alone are missing.
The CABACARE study is designed to assess the effects in terms of efficacy, safety as well as quality of life of omitting daily corticosteroids in patients treated with cabazitaxel. Furthermore, the CABACARE study evaluates the mutational status of the RB gene as well as presence of AR-V7 variant. The AR-V7 status assessed in circulating tumor cells has a strong predictive value for abiraterone/enzalutamide effectiveness, but its role in patients receiving cabazitaxel requires to be defined.
Detailed description
Patients will be randomly assigned (1:1) to receive either:
Arm A Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, plus prednisone 10 mg orally given daily. Premedication must be administered according to Cabazitaxel Package Insert.
Arm B Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, without daily prednisone. Premedication must be administered according to Cabazitaxel Package Insert.
Each patient will be treated until radiological disease progression, unacceptable toxicity, or patient refusal. Patients will be followed through subsequent therapy lines of treatments until death or the study cut-off, whichever comes first.
Every effort will be made to administer the full dose regimen to maximize dose-intensity.
Dose reduction and/or treatment delay and/or treatment discontinuation are planned in case of severe toxicity. If toxicity occurs, dose of Cabazitaxel can be reduced to 20 mg/mq in both arms. If a second dose reduction is required the patient should be withdrawn from study.
Prednisone doses should not be delayed or modified or stopped (unless there is a contraindication to continue, the decision will be let to the investigator's discretion).
In case a dose reduction is required, cabazitaxel dose cannot be re-escalated. Prophylactic use of G-CSF is allowed, as per EORTC / ASCO guidelines and according to physician judgment. Patients experiencing neutropenia G 3-4 have to receive G-CSF in prophylaxis in subsequent cycles.
Primary Objective(s)
To evaluate whether cabazitaxel alone is non inferior in terms of radiographic PFS with respect to cabazitaxel plus daily prednisone in patients with castration resistant prostate cancer
Secondary Objective(s)
Safety in the two treatment arms; Health-Related Quality of Life (HRQL) and pain; Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Biochemical response (assessed considering PSA decrease ≥50% and waterfall plot results); Time to PSA Progression (TTPP); Radiographic Time to Progression (rTTP); Overall Survival (OS); Association of Overall
l Survival (OS), Progression Free Survival (PFS) and Objective Response Rate (ORR) with AR-V7 and RB status in circulating tumor cells assessed at flow-cytometry; Time to Skeletal-Related Event (SRE);
Primary end Point
Radiographic Progression-Free Survival (rPFS).
Secondary end points
Safety in the two treatment arms; Health-Related Quality of Life HRQL and pain; Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Biochemical response (PSA decrease ≥50%, waterfall plot); Time to PSA Progression (TTPP); Radiographic Time To Progression (rTTP); Overall Survival (OS); Association of Overall Survival (OS), Progression Free Survival (PFS) and Objective Response Rate (ORR) with AR-V7 and RB status in circulating tumor cells by the use of a DNA test; Time to Skeletal-Related Event (SRE).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel plus prednisone | Active comparator | Drug: Cabazitaxel, Drug: PrednisoneCabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks, plus prednisone 10 mg orally given daily. Premedication must be administered according to Cabazitaxel Package Insert. |
| Cabazitaxel | Experimental | Drug: CabazitaxelCabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Premedication must be administered according to Cabazitaxel Package Insert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent.
- Histological diagnosis of prostate adenocarcinoma;
- Metastatic castration-resistant disease with documented radiographic progression (osseous or measurable lesions) during or after a docetaxel-based chemotherapy;
- Testosterone level in the castration range (levels <50 ng/dl) because of a previous, and ongoing, androgen deprivation with LH-RH agonists or antagonists or bilateral orchiectomy;
- Prior surgery and/or radiation therapy (to less or equal than 30% of the bone marrow) are allowed. However, at least 4 weeks must have been elapsed since surgery or completion of radiation therapy and the patient must has recovered from side effects;
Key exclusion criteria (13 listed)
- Participation in clinical trials with other investigational drug within 28 days of study entry;
- Symptomatic or uncontrolled brain metastases. Patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis; previously treated brain metastases will be allowed as long as the patient is neurologically stable and does not require steroids and anticonvulsants;
- Less than 4 weeks elapsed from prior anticancer-therapy or surgery to the time of randomization. Prior treatment with abiraterone or enzalutamide is allowed and is used as a stratification factor at randomization. Patient may be on biphosphonates prior to study entry;
- Less than 4 weeks from palliative Radiotherapy to time of randomization;
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, pulmonary embolism or other uncontrolled thromboembolic event;
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 |
|---|---|---|
| CabazitaxelCabazitaxel drug products should be administered only by intravenous route. Prednison should be administered by oral route | Drug | Cabazitaxel, Cabazitaxel plus prednisone |
| PrednisonePrednisone should be administred by oral route | Drug | Cabazitaxel plus prednisone |
Primary outcome
change from Baseline radiographic progression
Time frame: From date of randomization until the date of first documented progression or but also during follow-up in case study treatment was discontinued without radiographic progression up to 48 months"
Radiographic progression evaluated by RECIST 1.1 criteria with bone scan, chest abdominal and pelvi TC MRI
4 secondary outcomes
Health-Related Quality of Life and pain
Time frame: from the date of randomization and the date of either first documented pain progression or death due to any cause, whichever is earlier up to 48 months"
Adverse events
Time frame: From date of randomization until the date of first documented progression or but also during follow-up in case study treatment was discontinued up to 48 months" "
Health-Related Quality of Life
Time frame: From date of screening until the date of first documented progression up to 48 months"
AR-V7 and RB status in circulating tumor cells
Time frame: only at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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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.
Giuseppe Giuseppe, MD principal investigator
Università Federico II Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel and Prednisone in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Consorzio Oncotech at 1 site in Italy.
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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
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?
change from Baseline radiographic progression (time frame: From date of randomization until the date of first documented progression or but also during follow-up in case study treatment was discontinued without radiographic progression up to 48 months"). 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 14 Dec 2017.