Advanced Renal Cell CarcinomaPhase 2NCT03339219
A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma
A Phase 2 study testing Cabozantinib in people with Advanced Renal Cell Carcinoma, run by Takeda at 19 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 19 sitesJapan
- Study dates
- 13 Dec 2017to 25 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Japanese participants 20 years of age or older on the day of consent.
- Documented histological or cytological diagnosis of renal cell carcinoma (RCC) with a clear-cell component.
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
- For the most recently received VEGFR-targeting TKI the following criteria must apply:
- Must have radiographically progressed during treatment, or been treated for at least 4 weeks and radiographically progressed within 6 months after the last dose.
Show all 11Show fewer
- Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator on computerized tomography (CT) or magnetic resonance imaging (MRI) scans.
- The last dose must have been within 6 months before the first day of study drug administration (Week 1 Day 1).
- Recovery to baseline or ≤Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Karnofsky Performance Status (KPS) score of ≥70%.
- Adequate organ and marrow function at Screening.
Who cannot join
- Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1/phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib.
- Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1.
- Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1.
- Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1.
- Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Nippon Medcal School Hospital
Bunkyo-ku, Tokyo
Kyushu University Hospital
Fukuoka
Kobe University Hospital
Kobe, Hyōgo
Toranomon Hospital
Minato-ku, Tokyo
Nagoya University Hospital
Nagoya, Aichi-ken
Niigata University Medical and Dental Hospital
Niigata
Okayama University Hospital
Okayama
Osaka City University Hospital
Osaka
Osaka International Cancer Institute
Osaka
Hokkaido University Hospital
Sapporo, Hokkaido
Sapporo Medical University Hospital
Sapporo, Hokkaido
Kindai University Hospital
Sayama, Osaka
Keio University Hospital
Shinjuku-ku, Tokyo
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo
Osaka University Hospital
Suita, Osaka
Tokushima University Hospital
Tokushima
Yamagata University Hospital
Yamagata
Yokohama City University Hospital
Yokohama, Kanagawa
Yokohama City University Medical Center
Yokohama, Kanagawa
About this study
Official title: A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.
Read the detailed description
The drug being tested in this study is called cabozantinib. Cabozantinib is being tested to treat people who have advanced renal cell carcinoma. This study will look at the efficacy of cabozantinib.
The study will enroll approximately 35 patients. Participants will be enrolled in one treatment group in non-randomized and opened manner:
- Cabozantinib 60 mg
All participants will be asked to take tablets of cabozantinib at once daily in the fasted state throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately at most 3 years. Participants will make multiple visits to the clinic in treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- Cabozantinib
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Also called XL184
Cabozantinib tablets
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib 60 mg | Experimental | Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) evaluated by the independent review committee (IRC) per response evaluation criteria in solid tumors version 1.1 (RECIST V1.1) which was confirmed by a subsequent evaluation conducted ≥28 days later. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the Baseline SoD.
Measured: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)
Secondary outcomes (10)
Clinical Benefit Rate (CBR)
CBR was defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST V1.1. Response and progression were evaluated by IRC per RECIST V1.1. CR and PR required confirmation by a subsequent evaluation conducted ≥28 days later and an assessment of SD was made at least 8 weeks after the first day of study drug. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in the short axis to <10 mm. PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: From first dose of study drug up to first documentation of CR or PR or SD (up to 2.5 years)
Progression-Free Survival (PFS)
PFS was defined as the time from the first day of study drug administration to the earlier of progressive disease (PD) per RECIST V1.1 or death due to any cause. Per RECIST V1.1, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline. In addition to the relative increase of 20%, the SoD also demonstrated an absolute increase of at least 5 mm.
Measured: From first dose of study drug up to disease progression or death (up to 2.5 years)
Overall Survival (OS)
OS is defined as the time from the first day of study drug administration to death due to any cause.
Measured: From first dose of study drug up to death due to any cause (up to 2.5 years)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Grade 3 or Higher TEAEs
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment. Severity grade was defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. As per the NCI-CTCAE, Grade 1 scales as mild; Grade 2 scales as moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Serious TEAEs
A serious TEAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically important due to other reasons than the above-mentioned criteria. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Permanent Treatment Discontinuation
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Clinical laboratory tests included tests of serum chemistry, hematology, urine chemistry, coagulation, and thyroid function prespecified in the protocol. Only those categories are reported which are considered clinically significant abnormal laboratory values post baseline, as assessed by the investigator.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Vital Sign
Vital signs included diastolic blood pressure (DBP) and systolic blood pressure (SBP) in the sitting position, pulse rate respiratory rate temperature, and weight. Abnormal vital sign values considered by the investigator to be clinically significant are reported as categories.
Measured: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start13 Dec 2017
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339219
- Sponsor's protocol ID
- Cabozantinib-2001
- Other IDs
- U1111-1201-4230, JapicCTI-173763
- Status last verified
- Aug 2021
- First submitted
- 8 Nov 2017
- Last updated
- 20 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Nakaigawa N, Tomita Y, Tamada S, Tatsugami K, Osawa T, Oya M, Kanayama H, Miura Y, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Kimura A. Final efficacy and safety results and biomarker analysis of a phase 2 study of cabozantinib in Japanese patients with advanced renal cell carcinoma. Int J Clin Oncol. 2023 Mar;28(3):416-426. doi: 10.1007/s10147-022-02283-w. Epub 2023 Jan 3.
PubMed 36595123Tomita Y, Tatsugami K, Nakaigawa N, Osawa T, Oya M, Kanayama H, Nakayama Kondoh C, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Tanaka S, Kimura A, Tamada S. Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients. Int J Urol. 2020 Nov;27(11):952-959. doi: 10.1111/iju.14329. Epub 2020 Aug 12.
PubMed 32789967
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT03339219
- Acronym / sponsor ID
- Cabozantinib-2001
- Conditions
- Advanced Renal Cell Carcinoma
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 20 Sep 2021
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 evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.
Detailed description
The drug being tested in this study is called cabozantinib. Cabozantinib is being tested to treat people who have advanced renal cell carcinoma. This study will look at the efficacy of cabozantinib.
The study will enroll approximately 35 patients. Participants will be enrolled in one treatment group in non-randomized and opened manner:
- Cabozantinib 60 mg
All participants will be asked to take tablets of cabozantinib at once daily in the fasted state throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately at most 3 years. Participants will make multiple visits to the clinic in treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib 60 mg | Experimental | Drug: CabozantinibCabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female Japanese participants 20 years of age or older on the day of consent.
- Documented histological or cytological diagnosis of renal cell carcinoma (RCC) with a clear-cell component.
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
- For the most recently received VEGFR-targeting TKI the following criteria must apply:
Key exclusion criteria (5 listed)
- Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1/phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib.
- Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1.
- Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1.
- Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1.
- Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.
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 |
|---|---|---|
| CabozantinibAlso: XL184Cabozantinib tablets | Drug | Cabozantinib 60 mg |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)
ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) evaluated by the independent review committee (IRC) per response evaluation criteria in solid tumors version 1.1 (RECIST V1.1) which was confirmed by a subsequent evaluation conducted ≥28 days later. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the Baseline SoD.
10 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: From first dose of study drug up to first documentation of CR or PR or SD (up to 2.5 years)
Progression-Free Survival (PFS)
Time frame: From first dose of study drug up to disease progression or death (up to 2.5 years)
Overall Survival (OS)
Time frame: From first dose of study drug up to death due to any cause (up to 2.5 years)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Grade 3 or Higher TEAEs
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Serious TEAEs
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Permanent Treatment Discontinuation
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Vital Sign
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36595123Nakaigawa N, Tomita Y, Tamada S, Tatsugami K, Osawa T, Oya M, Kanayama H, Miura Y, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Kimura A. Final efficacy and safety results and biomarker analysis of a phase 2 study of cabozantinib in Japanese patients with advanced renal cell carcinoma. Int J Clin Oncol. 2023 Mar;28(3):416-426. doi: 10.1007/s10147-022-02283-w. Epub 2023 Jan 3.
- Derived from this study: PubMed 32789967Tomita Y, Tatsugami K, Nakaigawa N, Osawa T, Oya M, Kanayama H, Nakayama Kondoh C, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Tanaka S, Kimura A, Tamada S. Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients. Int J Urol. 2020 Nov;27(11):952-959. doi: 10.1111/iju.14329. Epub 2020 Aug 12.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Medical Director study director
Takeda
19 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 Cabozantinib in people with Advanced Renal Cell Carcinoma, run by Takeda at 19 sites in Japan.
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 11 inclusion and 5 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) (time frame: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)). 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 NCT03339219, which also lists 2 linked publications.
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 20 Sep 2021.