Metastatic Renal Cell CarcinomaPhase 2INDIGONCT04644432
Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
A Phase 2 study testing Medication (A specification is listed under each arm) and Patient reported outcomes measurement in people with Metastatic Renal Cell Carcinoma and Kidney Neoplasm, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms
- What is being tested?
- Medication (A specification is listed under each arm) and Patient reported outcomes measurement
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Mar 2020to 6 Sep 2022
- 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
- Signed informed consent form must be obtained before any study-related procedures start.
- The patient must be willing and able to follow the protocol.
- Age ≥ 18 years
- Histological biopsy-confirmed inoperable, locally advanced or metastatic non-cc RCC or 100% sarcomatoid tumour arising from the kidney found unsuited for surgery with a curative intent. Nephrectomy is not mandatory.
- If the primary disease was diagnosed more than 1 year ago, a fresh medium needle biopsy must be collected to confirm the diagnosis and tissue must be collected for DNA and RNA analyses.
- If a patient with inoperable relapse had a nephrectomy less than 1 year ago, and no tissue samples are stored in Dansk CancerBiobank, a fresh medium needle biopsy must be collected for DNA and RNA analyses.
Show all 19Show fewer
- In cases where metastatic disease was confirmed by biopsy more than 1 year ago without initiated treatment, the patient is offered a fresh medium needle biopsy, but this is not mandatory for inclusion.
- If the patient had a nephrectomy using tissue from Dansk CancerBiobank and has been diagnosed with metastases within 1 year, the patient must be offered a fresh medium needle biopsy from a metastasis if the metastasis is easily accessible for biopsy, but a fresh biopsy is not mandatory for inclusion.
- A medium needle biopsy is mainly taken from a metastasis, but biopsy from a renal tumour is allowed.
- A biopsy may not be taken from bones as it cannot be used for molecular analysis.
- If the primary tumour is a proven clear cell RCC, but the biopsy from a metastasis shows non-cc RCC, the patient can be included in the study.
- Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells.
- Females with a negative pregnancy test or of non-childbearing potential (menopausal, hysterectomy or ovariectomy) and non-breastfeeding.
- Females of childbearing potential (<2 years after last menstrual period) and males must use effective contraception (pills, intrauterine device, diaphragm or condom with spermicide or sterilisation).
- Measurable disease (according to RECIST 1.1 criteria)
- Karnofsky Performance status ≥ 70% / ECOG Performance status 0-2.
- Life expectancy more than 3 months.
- At baseline, the laboratory values must be: Haematology: Leukocytes ≥ 3.0 x 109/l, thrombocytes ≥ 100 x 109/l, haemoglobin ≥ 6.2 mmol/l.
- Biochemistry: International Normalized Ratio (INR) ≤ 1.5, APTT ≤ 1.5 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 x ULN, aspartate transaminase, alanine aminotransferase ≤ 2.5 x ULN for patients without liver metastases, ≤ 5 x ULN for patients with liver metastases. Estimated glomerular filtration rate (eGFR) > 30.
Who cannot join
- Previous systemic treatment for metastatic RCC (including neoadjuvant treatment).
- Former adjuvant treatment with immune checkpoint inhibitors.
- Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation.
- Serious non-healing wound, ulcer or bone fracture.
- Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs
- Metastases in the central nervous system (CNS). The patient must have an MRI scan (preferred) or CT scan of the brain (using contrast agent if possible) within 28 prior to initiation.
Show all 14Show fewer
- Seizures which cannot be managed with standard medical treatment.
- If urine dipstick with protein ≥ 3+, urine must be collected over a period of 24 hours which must be < 3.5 grams/day. If degree 2 proteinuria, urine must be collected over a period of 24 hours prior to each prescription.
- Other malignancy within 5 years (except for curatively treated basal cell carcinoma of the skin and/or cervix carcinoma in situ).
- Uncontrolled hypertension (≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic) despite maximum antihypertensive medical treatment.
- Clinically significant (i.e. active) cardiovascular disease, such as cerebrovascular conditions (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) congestive heart failure ≥ degree III or serious cardiac arrhythmia requiring medical treatment. Patients with well-managed Atrial fibrillation/ atrial flutter may be included.
- Treatment using other investigational drugs or participation in other studies.
- Previous or current other diseases, metabolic dysfunction, clinical findings on physical examination or clinical laboratory findings that give suspicion of a disease or condition that would contraindicate the use of an investigational drug or a patient with a high risk of treatment complications.
- Patients where the investigator finds that patient compliance prevents safe completion of the treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Herlev and Gentofte Hospital
Herlev, 2730
Anne Kirstine H Moeller, MD, PhD, +4538681083, anne.kirstine.hundahl.moeller@regionh.dk
Jesper A Palshof, MD, PhD, +4538686161, jesper.andreas.palshof@regionh.dk
About this study
Official title: A Phase II Study of an Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Moreover, to involve the patient further in their treatment via patient-reported outcomes (PRO) measurements in a value-based healthcare setup with simultaneous analyses of the financial costs of this strategy.
The patients are assigned into 4 treatment arms according to the results of their DNA and RNA analyses. All patients receive electronic questionnaires regarding symptoms and side effects weekly and questionnaires regarding quality of life monthly. Based on each patient's answers of the questionnaires the patient receives advices in the app to reduce the symptoms and side effects or the patient is instructed to contact the hospital.
The hypothesis: Basing the choice of first-line treatment for DNA mutations and RNA profiles in a heterogeneous patient population increases the overall response rate for the total population to 30% compared to 10% for historical cohorts.
- Conditions
- Metastatic Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms, Urogenital Neoplasms
- Being tested
- Medication (A specification is listed under each arm), Patient reported outcomes measurement
- Keywords
- non-clear cell renal cell carcinoma, liquid biopsy, patient reported outcomes, gene expression
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication (A specification is listed under each arm)Drug
Study drugs and dosages are listed in the description of arms.
Patient reported outcomes measurementOther
Also called PRO
PRO questionnaires regarding symptoms and side effects with questions selected from the Nation Cancer Institute Patient Reported Outcomes-Common Terminology Criteria for Adverse Events.
The patient receive individual advices according to the patient's answers to reduce the symptoms and side effects or is instructed to contact the hospital.
For monitoring quality of life the EORTC QLQ-C30 is used. All questionnaires are in Danish.
| Study group | Role | What they receive |
|---|---|---|
| A - for patients with a DNA mutation that match a targeted treatment | Experimental | Listed below are the possible study drugs and dosages:
Erlotinib 150 mg once a day for 4 weeks.
Osimertinib 80 mg once a day for 4 weeks.
Alectinib 600 mg twice a day for 4 weeks
Dabrafenib 150 mg twice a day combined with Trametinib 2 mg once a day for 4 weeks
Trastuzumab-emtansin iv infusion 3.6 mg/kg every 3rd week
Olaparib 400 mg twice a day for 4 weeks
Pembrolizumab iv infusion 2 mg/kg every 3rd week
Cabozantinib 60 mg once a day for 4 weeks
Crizotinib 250 mg twice a day for 4 weeks
Palbociclib 125 mg once a day in3 weeks, hereafter pause for one week
Imatinib 400 mg once a day for 4 weeks
If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. Receives: Drug: Medication (A specification is listed under each arm); Other: Patient reported outcomes measurement |
| B - for patients with an angiogen profile | Experimental | Study drug: Sunitinib peroral tablet 50 mg once a day for 4 weeks, hereafter pause for 2 weeks (4/2 schedule or 2/1 schedule).
If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. Receives: Drug: Medication (A specification is listed under each arm); Other: Patient reported outcomes measurement |
| C - for patients with an immune profile | Experimental | Study drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week.
If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. Receives: Drug: Medication (A specification is listed under each arm); Other: Patient reported outcomes measurement |
| D - for patients that have neither mutations nor an immune- or angiogen profile | Experimental | Study drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week.
If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. Receives: Drug: Medication (A specification is listed under each arm); Other: Patient reported outcomes measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The total share of patients who have received treatment with complete and partial response assessed radiologically based on RECIST v.1.1.
Measured: 30 months
Time to treatment failure (TTF)
The time from start up day 1 until discontinuation of treatment, regardless of the reason.
Measured: 30 months
Secondary outcomes (8)
Overall Survival (OS)
Overall survival for the total population
Measured: 30 months
Progression-Free Survival (PFS)
Progression-free survival for the total population
Measured: 30 months
Disease Control Rate (DCR)
Disease control rate (complete response + partial response + stabile disease) for the total population based on RECIST v1.1 criteria
Measured: 30 months
Response duration
Response duration for the total population.
Measured: 30 months
Use of PRO tools
The patients' use of PRO tools during treatment assessed with the validated Patient Feedback Form
Measured: 30 months
PRO and PRO-CTCAE
Number of and changes in Patient-reported outcomes according to PRO-CTCAE from baseline.
Measured: 30 months
NCI-CTCAE
Number of and types of adverse events according to NCI-CTCAE
Measured: 30 months
Hospital admissions
Number of hospital admissions
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start6 Mar 2020
- Primary completion6 Sep 2022 (estimated)
- Study completion6 Sep 2022 (estimated)
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 Metastatic Renal Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida Rasmussen, Herlev and Gentofte Hospital
- Investigators
- Ida Marie L Rasmussen, MD, Principal investigator, Department of Oncology, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644432
- Sponsor's protocol ID
- UR1909
- Other IDs
- 2019-001316-38, PACTIUS, GCP, 2019
- Acronym
- INDIGO
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen IML, Soerensen AV, Moller AK, Persson GF, Palshof JA, Taarnhoj GA, Pappot H. Individualizing the Oncological Treatment of Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study. JMIR Res Protoc. 2022 Sep 15;11(9):e36632. doi: 10.2196/36632.
PubMed 36107483
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of an Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04644432
- Acronym / sponsor ID
- INDIGO / UR1909
- Conditions
- Metastatic Renal Cell Carcinoma, Kidney Neoplasm, Urologic Neoplasms, Urogenital Neoplasms
- Keywords
- non-clear cell renal cell carcinoma, liquid biopsy, patient reported outcomes, gene expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 6 Sep 2022 (estimated)
- Study completion
- 6 Sep 2022 (estimated)
- First posted
- 25 Nov 2020 (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.
The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Moreover, to involve the patient further in their treatment via patient-reported outcomes (PRO) measurements in a value-based healthcare setup with simultaneous analyses of the financial costs of this strategy.
The patients are assigned into 4 treatment arms according to the results of their DNA and RNA analyses. All patients receive electronic questionnaires regarding symptoms and side effects weekly and questionnaires regarding quality of life monthly. Based on each patient's answers of the questionnaires the patient receives advices in the app to reduce the symptoms and side effects or the patient is instructed to contact the hospital.
The hypothesis: Basing the choice of first-line treatment for DNA mutations and RNA profiles in a heterogeneous patient population increases the overall response rate for the total population to 30% compared to 10% for historical cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - for patients with a DNA mutation that match a targeted treatment | Experimental | Drug: Medication (A specification is listed under each arm), Other: Patient reported outcomes measurementListed below are the possible study drugs and dosages: Erlotinib 150 mg once a day for 4 weeks. Osimertinib 80 mg once a day for 4 weeks. Alectinib 600 mg twice a day for 4 weeks Dabrafenib 150 mg twice a day combined with Trametinib 2 mg once a day for 4 weeks Trastuzumab-emtansin iv infusion 3.6 mg/kg every 3rd week Olaparib 400 mg twice a day for 4 weeks Pembrolizumab iv infusion 2 mg/kg every 3rd week Cabozantinib 60 mg once a day for 4 weeks Crizotinib 250 mg twice a day for 4 weeks Palbociclib 125 mg once a day in3 weeks, hereafter pause for one week Imatinib 400 mg once a day for 4 weeks If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. |
| B - for patients with an angiogen profile | Experimental | Drug: Medication (A specification is listed under each arm), Other: Patient reported outcomes measurementStudy drug: Sunitinib peroral tablet 50 mg once a day for 4 weeks, hereafter pause for 2 weeks (4/2 schedule or 2/1 schedule). If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. |
| C - for patients with an immune profile | Experimental | Drug: Medication (A specification is listed under each arm), Other: Patient reported outcomes measurementStudy drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week. If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. |
| D - for patients that have neither mutations nor an immune- or angiogen profile | Experimental | Drug: Medication (A specification is listed under each arm), Other: Patient reported outcomes measurementStudy drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week. If the patient can fit in several arms, arm A or the arm closest to arm A is chosen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent form must be obtained before any study-related procedures start.
- The patient must be willing and able to follow the protocol.
- Age ≥ 18 years
- Histological biopsy-confirmed inoperable, locally advanced or metastatic non-cc RCC or 100% sarcomatoid tumour arising from the kidney found unsuited for surgery with a curative intent. Nephrectomy is not mandatory.
- Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells.
Key exclusion criteria (14 listed)
- Previous systemic treatment for metastatic RCC (including neoadjuvant treatment).
- Former adjuvant treatment with immune checkpoint inhibitors.
- Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation.
- Serious non-healing wound, ulcer or bone fracture.
- Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs
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 |
|---|---|---|
| Medication (A specification is listed under each arm)Study drugs and dosages are listed in the description of arms. | Drug | A - for patients with a DNA mutation that match a targeted treatment, B - for patients with an angiogen profile, C - for patients with an immune profile, D - for patients that have neither mutations nor an immune- or angiogen profile |
| Patient reported outcomes measurementAlso: PROPRO questionnaires regarding symptoms and side effects with questions selected from the Nation Cancer Institute Patient Reported Outcomes-Common Terminology Criteria for Adverse Events. The patient receive individual advices according to the patient's answers to reduce the symptoms and side effects or is instructed to contact the hospital. For monitoring quality of life the EORTC QLQ-C30 is used. All questionnaires are in Danish. | Other | A - for patients with a DNA mutation that match a targeted treatment, B - for patients with an angiogen profile, C - for patients with an immune profile, D - for patients that have neither mutations nor an immune- or angiogen profile |
Primary outcome
Overall response rate (ORR)
Time frame: 30 months
The total share of patients who have received treatment with complete and partial response assessed radiologically based on RECIST v.1.1.
Time to treatment failure (TTF)
Time frame: 30 months
The time from start up day 1 until discontinuation of treatment, regardless of the reason.
8 secondary outcomes
Overall Survival (OS)
Time frame: 30 months
Progression-Free Survival (PFS)
Time frame: 30 months
Disease Control Rate (DCR)
Time frame: 30 months
Response duration
Time frame: 30 months
Use of PRO tools
Time frame: 30 months
PRO and PRO-CTCAE
Time frame: 30 months
NCI-CTCAE
Time frame: 30 months
Hospital admissions
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 36107483Rasmussen IML, Soerensen AV, Moller AK, Persson GF, Palshof JA, Taarnhoj GA, Pappot H. Individualizing the Oncological Treatment of Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study. JMIR Res Protoc. 2022 Sep 15;11(9):e36632. doi: 10.2196/36632.
- Individual participant dataSharing planned: No
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Ida Marie L Rasmussen, MD principal investigator
Department of Oncology, Herlev and Gentofte Hospital
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 Medication (A specification is listed under each arm) and Patient reported outcomes measurement in people with Metastatic Renal Cell Carcinoma and Kidney Neoplasm, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 19 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: status not confirmed, as of the sponsor's last update on 25 Nov 2020. 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 Denmark. 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?
Contact Anne Kirstine H Moeller, MD, PhD (+4538681083, anne.kirstine.hundahl.moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 30 months). 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?
On the ClinicalTrials.gov record for NCT04644432, 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 25 Nov 2020.