Solid TumorPhase 1NCT05244551
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
A Phase 1 study testing ABSK061 in people with Solid Tumor, run by Abbisko Therapeutics Co, Ltd at 22 sites in 2 countries.
Trial summary
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ABSK061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 30 Jun 2022to 30 Apr 2025
- 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
- Patient should understand, sign, and date the written informed consent form prior to screening.
- Male or female age 18 years or older.
- For escalation part: patients with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
- For expansion Part:
- Patients with histologically confirmed urothelial carcinoma or cholangiocarcinoma who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
- Patients must have tumors with following FGFR2/3 genetic alterations based on central laboratory test or existing test reports: Urothelial carcinoma: FGFR2/3 fusions and FGFR3 activating mutations Cholangiocarcinoma: FGFR2 fusions and/or arrangements
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- Patients must have at least one measurable target lesion according to RECIST 1.1.
- Patients are willing to undergo biopsy if archival tumor tissue is not available or the archival specimen deemed inadequate or confirmed FGFR2/3 alterations from existing reports is not available.
- 4. ECOG performance status 0 or 1 5. Life expectancy ≥3 months 6. Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study drug:
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelet count (PLT) ≥ 100×109/L without transfusion requirement within 14 days before 1st dose
- Hemoglobin (Hb)≥90 g/L
- Total bilirubin (TBIL) ≤1×ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN.
- Serum creatinine (Cr) of ≤1.5×ULN for the reference laboratory or creatinine clearance (Crcl) ≥ 50 mL/min based on Cockcroft-Gault formula
Who cannot join
- Known allergy or hypersensitivity to any component of the investigational product
- For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)
- Has a known additional malignancy that is progressing or has required active treatment.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
- Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy or other investigational drugs received ≤4 weeks; endocrine therapy ≤2 weeks or ≤5-half life (whichever is shorter) prior to initiation of study treatment.
- Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence.
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- Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE V5.0) with the exception of alopecia and vitiligo.
- Concomitant use of the drugs/remedies that may cause pharmacokinetic drug-drug interactions; consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges or juice products within 7 days prior to the first dose of study medication.
- Active central nervous system (CNS) metastases including presence of cerebral edema, requirement for systemic steroid treatment, disease progression due to intracranial lesions, leptomeningeal metastasis, and other clinical symptoms related to CNS metastases.
- Impaired cardiac function or clinically significant cardiac disease, including any one of the following:
- New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure
- Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QTcF >470 ms or history of long QT interval corrected (QTc) syndrome (Note: QTc interval corrected by Fridericia's formula).
- Left ventricular ejection fraction (LVEF) <50% or below the institutional lower limit of normal (whichever is higher)
- Known human immunodeficiency virus (HIV) or active hepatitis B, or active hepatitis C infection; positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to hepatitis B core Ag (HBcAb), or hepatitis C RNA in serum (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction (PCR) test are allowed; positive tests for HBV HBsAg or HBcAb with HBV-DNA measurements lower than 1000IU/ml can be included)
- Any of the following ophthalmological criteria:
- Current evidence or previous history of retinal pigmented epithelial detachment (RPED)
- Previous laser treatment or intra-ocular injection for treatment of macular degeneration
- Current evidence or previous history of dry or wet age-related macular degeneration
- Current evidence or previous history of retinal vein occlusion (RVO)
- Current evidence or previous history of retinal degenerative diseases (eg, hereditary)
- Current evidence or previous history of any other clinically relevant chorioretinal defect
- Current evidence or previous history of corneal pathology such as conjunctivitis, keratopathy, corneal abrasion or ulceration
- Patients with refractory/uncontrolled ascites or pleural effusion.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.
- Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study and for up to 6 months after the last dose of study drug.
- Sexually active males, unless they use a condom during intercourse while taking drug and for 5 consecutive compound half-lives plus 60 days after stopping study drug, should not father a child. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid.
- Vaccination with a live, attenuated vaccine within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
China21 sites, 21 recruiting
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Ning Li, MD
Ning Li, MD
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Hongtao Li, MD
Hongtao Li, MD
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Wei Li, MD
Wei Li, MD
- Not yet recruiting
JILIN Cancer Hospital
Changchun, Jilin
Ying Chen, MD
Ying Chen, MD
- Not yet recruiting
Chongqing Daping Hospital
Chongqing, Chongqing Municipality
Mengxia Li, MD
Mengxia Li, MD
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Sichuan
Dewei Li, MD
Dewei Li, MD
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Zhiyong He, MD
Zhiyong He, MD
- Recruiting
Sun Yat-sen Memorial Hospital/ the Second Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong
Herui Yao, MD
Herui Yao, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Gongshu District
Ji Zhu, MD
Ji Zhu, MD
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang
Yuan Ding, MD
Yuan Ding, MD
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yan Yu, MD
Yan Yu, MD
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Qun Hu, MD
Qun Hu, MD
- Recruiting
Yuan LU
Shanghai, Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, 201203
LU Yuan, 021-68910052, clinical@abbisko.cn
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Shun Lu, MD
Shun Lu, MD
- Recruiting
Liaoning Province Cancer Hospital
Shenyang, Liaoning
Yan Zhao, MD
Yan Zhao, MD
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Fujian Liu, MD
Fujian Liu, MD
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaorong Dong, MD
Xiaorong Dong, MD
- Recruiting
Xuzhou Center Hospital
Xuzhou, Jiangsu
Yuan Yuan, MD
Yuan Yuan, MD
- Not yet recruiting
Yunnan Cancer Hospital
Yunnan, Kunming
Runxiang Yang, MD
Runxiang Yang, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Shujun Yang, MD
Shujun Yang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yanru Qin, MD
Yanru Qin, MD
United States1 site, 1 recruiting
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Reva Schneider, MD, 972-566-3000, Referral@MaryCrowley.Org
Reva Schneider, MD
About this study
Official title: A Phase 1, Open-Label Study of ABSK061 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Read the detailed description
Escalation Part:
Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed.
Expansion Part:
When health authorities outside US require safety data in local population be provided prior to expansion part, a minimum of 3 local subjects will be enrolled and treated at the selected RDE dose level first in that country/region to evaluate the tolerability of ABSK061. The inclusion and exclusion criteria for escalation part will apply for these subjects. After similar safety and tolerability of ABSK061 in patients in the relevant locality have been confirmed by local Investigators and the Sponsor, additional patients will be allowed to enroll in the expansion part.
- Conditions
- Solid Tumor
- Being tested
- ABSK061
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK061Drug
In the escalation part, patients will receive a single dose of oral ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in subsequent cycles (28-day cycles). The starting dose is 5 mg BID. In the expansion part, patients will each receive oral ABSK061 at the RDE in repeated 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| ABSK061 | Experimental | Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed. Receives: Drug: ABSK061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Incidence and severity of adverse events (AEs)
adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Measured: Through study completion, an average of half year
Secondary outcomes (15)
Cmax
maximum observed concentration
Measured: Through the study completion, an average of half year
Tmax
time to maximum observed concentration
Measured: Through the study completion, an average of half year
AUC
area under the concentration-time curve
Measured: Through the study completion, an average of half year
t1/2
half-life
Measured: Through the study completion, an average of half year
Vz/F
apparent volume of distribution
Measured: Through the study completion, an average of half year
CL/F
apparent oral clearance
Measured: Through the study completion, an average of half year
Css_max
maximum observed concentration of steady-state
Measured: Through the study completion, an average of half year
Css_min
minimum observed concentration of steady/state
Measured: Through the study completion, an average of half year
AUCss
area under the concentration-time curve of steady/state
Measured: Through the study completion, an average of half year
Rac
accumulation rate
Measured: Through the study completion, an average of half year
ORR
Overall response rate
Measured: Through the study completion, an average of half year
DoR
Duration of response
Measured: Through the study completion, an average of half year
DCR
Disease control rate
Measured: from onset of PR or CR to disease progression (up to 100 months)
DoR
Duration of response
Measured: at 24 weeks
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start30 Jun 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244551
- Sponsor's protocol ID
- ABSK061-101
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of ABSK061 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05244551
- Acronym / sponsor ID
- ABSK061-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Feb 2022 (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.
This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Detailed description
Escalation Part:
Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed.
Expansion Part:
When health authorities outside US require safety data in local population be provided prior to expansion part, a minimum of 3 local subjects will be enrolled and treated at the selected RDE dose level first in that country/region to evaluate the tolerability of ABSK061. The inclusion and exclusion criteria for escalation part will apply for these subjects. After similar safety and tolerability of ABSK061 in patients in the relevant locality have been confirmed by local Investigators and the Sponsor, additional patients will be allowed to enroll in the expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSK061 | Experimental | Drug: ABSK061Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient should understand, sign, and date the written informed consent form prior to screening.
- Male or female age 18 years or older.
- For escalation part: patients with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
- Patients with histologically confirmed urothelial carcinoma or cholangiocarcinoma who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
- Patients must have tumors with following FGFR2/3 genetic alterations based on central laboratory test or existing test reports: Urothelial carcinoma: FGFR2/3 fusions and FGFR3 activating mutations Cholangiocarcinoma: FGFR2 fusions and/or arrangements
Key exclusion criteria (28 listed)
- Known allergy or hypersensitivity to any component of the investigational product
- For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)
- Has a known additional malignancy that is progressing or has required active treatment.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
- Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy or other investigational drugs received ≤4 weeks; endocrine therapy ≤2 weeks or ≤5-half life (whichever is shorter) prior to initiation of study treatment.
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 |
|---|---|---|
| ABSK061In the escalation part, patients will receive a single dose of oral ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in subsequent cycles (28-day cycles). The starting dose is 5 mg BID. In the expansion part, patients will each receive oral ABSK061 at the RDE in repeated 28-day cycles. | Drug | ABSK061 |
Primary outcome
Incidence of DLT
Time frame: At the end of Cycle 1 (each cycle is 28 days)
dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs)
Time frame: Through study completion, an average of half year
adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
15 secondary outcomes
Cmax
Time frame: Through the study completion, an average of half year
Tmax
Time frame: Through the study completion, an average of half year
AUC
Time frame: Through the study completion, an average of half year
t1/2
Time frame: Through the study completion, an average of half year
Vz/F
Time frame: Through the study completion, an average of half year
CL/F
Time frame: Through the study completion, an average of half year
Css_max
Time frame: Through the study completion, an average of half year
Css_min
Time frame: Through the study completion, an average of half year
AUCss
Time frame: Through the study completion, an average of half year
Rac
Time frame: Through the study completion, an average of half year
ORR
Time frame: Through the study completion, an average of half year
DoR
Time frame: Through the study completion, an average of half year
DCR
Time frame: from onset of PR or CR to disease progression (up to 100 months)
DoR
Time frame: at 24 weeks
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABSK061 in people with Solid Tumor, run by Abbisko Therapeutics Co, Ltd at 22 sites in 2 countries.
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 15 inclusion and 28 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China, United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan LU (+86 21 68910052, clinical@abbisko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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?
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 12 Aug 2024.