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813 Diseases | | 160 Products |
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1554 Trials |  |
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- Lumakras (sotorasib) / Amgen
Sotorasib plus carboplatin and pemetrexed in KRAS G12C advanced NSCLC: Updated analysis from the international CodeBreaK 101 trial. (Hall B1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1984;
P1, P3
Sotorasib plus platinum doublet chemotherapy conferred robust and durable responses with a manageable safety profile in CodeBreaK 101, supporting evaluation of this regimen in the ongoing CodeBreaK 202 phase 3 trial in treatment na
- Ibrance (palbociclib) / Pfizer, Lynparza (olaparib) / Merck (MSD), AstraZeneca
HOPE: Harnessing olaparib, palbociclib, and endocrine therapy for BRCA1/2-associated HR+, HER2- metastatic breast cancer. (Hall A; Poster Bd #: 143) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1664;
P1/2
Although no AEs meeting protocol-specified DLT criteria were observed at MTD, hematologic toxicity at this dose complicated drug delivery and required close monitoring during and after the DLT period. Combinations utilizing PARP1 selective inhibitors, lower doses of therapy or sequential rather than combination therapy may improve feasibility.
- Keytruda (pembrolizumab) / Merck (MSD), Lumakras (sotorasib) / Amgen
Sotorasib versus pembrolizumab in combination with platinum doublet chemotherapy as first-line treatment for metastatic or locally advanced, PD-L1 negative, KRAS G12C-mutated NSCLC (CodeBreaK 202). (Hall A; Poster Bd #: 514a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1526;
P3
Approximately 750 patients are planned to be enrolled and recruitment began on November 18, 2023. Contact Amgen Medical Information for more information: .
- HBI-2438 / HUYA Bioscience
Therapeutic activity of a new KRAS G12C inhibitor JMKX001899 in brain metastases: Preclinical models of KRAS G12C -mutant non-small cell lung cancer. (Hall A; Poster Bd #: 494) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1504;
The preclinical models in vivo suggest the new KRAS G12C inhibitor JMKX001899 penetrates the central nervous system and show great inhibition of KRAS G12C -mutant NSCLC with BM, which demonstrates therapeutic activity of JMKX001899 in BM. These data support further development of JMKX001899 in patients with KRAS G12C -mutant NSCLC with BM.
- Lumakras (sotorasib) / Amgen
Final analysis of SCARLET study: A single-arm, phase II study of sotorasib plus carboplatin-pemetrexed in patients with advanced non-squamous, non-small cell lung cancer KRAS G12C mutation. (Hall A; Poster Bd #: 480) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1490;
These data support further development of JMKX001899 in patients with KRAS G12C -mutant NSCLC with BM. Sotorasib in combination with CBDCA/PEM demonstrated favorable ORR with modest PFS and good tolerability in advanced non-Sq, NSCLC patients with KRAS G12C mutation.
- Lumakras (sotorasib) / Amgen
Characteristics and clinical outcomes of US veterans with advanced non (Hall A; Poster Bd #: 445) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1456;
Sotorasib in combination with CBDCA/PEM demonstrated favorable ORR with modest PFS and good tolerability in advanced non-Sq, NSCLC patients with KRAS G12C mutation. In this cohort, KRAS G12C appears to confer a favorable prognosis compared to non-G12C variants, which may be explained in part by the adoption of sotorasib.
- Vectibix (panitumumab) / Amgen, Lumakras (sotorasib) / Amgen
Sotorasib plus panitumumab for pre-treated non-small cell lung cancer with KRAS G12C mutation: A phase 1b study. (Hall A; Poster Bd #: 423) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1435;
P1
This cohort of sotorasib plus panitumumab in pre-treated patients with KRAS G12C advanced NSCLC demonstrated safety consistent with each drug's profile. The ORR appears promising in this pretreated population and may warrant further investigation.
- Krazati (adagrasib) / BMS
Gene expression correlates of adagrasib response in KRAS G12C mutated non-small cell lung cancer (NSCLC). (Hall A; Poster Bd #: 393) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1406;
Expression of the AST plasticity signature and KRT6A at baseline correlates with poor adagrasib responses. These data indicate the role of AST in KRAS inhibitor resistance and provide predictive biomarkers for KRAS-targeted therapies in lung cancer.
- Tagrisso (osimertinib) / AstraZeneca, Lumakras (sotorasib) / Amgen
Survival and mutational differences based on ESR1 and ESR2 expression in non-small cell lung cancer (NSCLC). (Hall A; Poster Bd #: 390) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1403;
ESR1-H/ESR2-H tumors had the highest MPAS and longest OS and there were SST differences with EGFR and KRAS G12C inhibition. ESR1&2 may play key roles in activating the MAPK pathway and future trials could consider targeted therapy combined with ER inhibition based on ESR1&2 expression.
- Ibrance (palbociclib) / Pfizer
Relationship of adaptive subtyping and tumour heterogeneity of treatment response to neoadjuvant therapy in hormone receptor (Hall A; Poster Bd #: 158) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1294;
P3
Adaptive subtyping can complement the classical approach, focusing on those genes that are changed during therapy. Comparison of paired samples before and after therapy is superior to classical subtyping of baseline samples.
- Ibrance (palbociclib) / Pfizer
Analysis of the sensitivity to endocrine therapy (SET) assay in the PALLAS adjuvant trial of palbociclib in HR+/HER2- breast cancer (ABCSG-42/AFT-05/BIG-14-13). (Hall A; Poster Bd #: 130) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1266;
P3
There was no evidence that the SET2,3 or SETER/PR index of endocrine-related transcriptional activity predicts benefit from palbociclib treatment. SET2,3 index was strongly prognostic for pts with Stage II-III breast cancer, with excellent 5-year IDFS for pts classified as SET2,3 high.
- tapotoclax (AMG 176) / Amgen
A phase I study of the myeloid cell leukemia 1 (MCL1) inhibitor tapotoclax (AMG 176) in patients with myelodysplastic syndromes after hypomethylating agent failure. (Hall A; Poster Bd #: 129) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1206;
P1
No DLTs were observed, and cardiac AEs self-resolved without dose reductions. Though no pts responded, some pts experienced transient blast reduction and decreased RBC transfusion burden.
- Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Clinical benefit of luspatercept treatment (tx) in transfusion-dependent (TD), erythropoiesis-stimulating agent (ESA) (Hall A; Poster Bd #: 124) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1201;
P3
Though no pts responded, some pts experienced transient blast reduction and decreased RBC transfusion burden. Pts were randomized 1:1 to subcutaneous administration of luspatercept (1.0
- Blincyto (blinatumomab) / Astellas, Amgen
Outpatient blinatumomab with digital monitoring in patients with measurable residual disease positive (MRD+) B-ALL in a phase 4 study. (Hall A; Poster Bd #: 103) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1181;
P4
To date, outpt administration of cIV blinatumomab in pts with MRD+ B-ALL was feasible and safe with appropriate outpt digital monitoring. Study enrollment is ongoing.
- PMB-CT01 / PeproMene Bio
PMB-CT01 (BAFFR-CAR T cell) therapy to examine preliminary safety and clinical responses in patients with B-cell malignancies who are ineligible for or failed CD19-directed therapy, including CD19-negative disease. (Hall A; Poster Bd #: 93) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1171;
P1
The B-ALL patient had CD19/CD20/CD22-negative disease, and had received prior blinatumomab. With a 100% CR rate at 3 months in the first 4 patients and durable responses at dose level 1, BAFFR-CAR T cells are a promising therapeutic option for patients with r/r B-cell malignancies who are ineligible or failed prior CD19-targeted therapy, including with CD19 antigen loss.
- Tecartus (brexucabtagene autoleucel) / Gilead
Long-term survival outcomes of patients (pts) with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-3. (Hall A; Poster Bd #: 90) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1168;
P1/2
Small subgroups and unbalanced pt characteristics limit interpretation of these results. No new safety signals were observed.
- Venclexta (venetoclax) / Roche, AbbVie
FLAG-IDA + venetoclax in newly diagnosed (ND) or relapsed/refractory (RR) AML. (Hall A; Poster Bd #: 78) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1156;
P1/2
No new safety signals were observed. Induction comprised fludarabine 30mg/m 2 D2
- obecabtagene autoleucel (AUTO1) / Autolus
Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX phase Ib/II study. (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1139;
P1/2
Induction comprised fludarabine 30mg/m 2 D2 Pts received bridging therapy as appropriate and underwent lymphodepletion (fludarabine, 4
- Impact of trial eligibility criteria on enrollment to KRAS G12C inhibitor trials in patients with non-small cell lung cancer. (S102) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1122;
EC did not expand after early phase trials demonstrated evidence of safety. These data should guide sponsor and FDA considerations in the development of trial protocols for targeted therapies, as fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results.
- Ibrance (palbociclib) / Pfizer
A deep learning (Hall A; Poster Bd #: 371) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1105;
A semi-automated workflow enabled rapid and accurate determination of rwPFS in mBC patients receiving a combination chemotherapy regimen. Further evaluation of this workflow to estimate rwPFS in other cancers and therapeutic settings is warranted.
- Medicare reimbursement trends of biological reference agents and their biosimilars. (Hall A; Poster Bd #: 350) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1084;
Biosimilar competition breaks the price increase trends with reference agents and contributes to a decrease in reference agent drug reimbursement. The effects of manufacturer rebates, payer policies, 340b programs, and discounts on ASP and Medicare reimbursement are also areas of active investigation.
- Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma
Inpatient burden and clinical outcomes of cytokine release syndrome in patients with cancer: A National Inpatient Sample study. (Hall A; Poster Bd #: 262) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1000;
CRS admissions are commonly seen in patients with hematologic malignancies, those undergoing CAR-T cell or immunotherapies (bispecific antibodies). CRS poses a significant healthcare burden, with average hospital charges being greater than 0.5 million US dollars per admission.
- Lonsurf (trifluridine/tipiracil) / Otsuka, Stivarga (regorafenib) / Bayer, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
The impact of multiple pharmacy use on medication adherence in individuals with colorectal cancer. (Hall A; Poster Bd #: 236) - Apr 24, 2024 - Abstract #ASCO2024ASCO_976;
In this study of individuals with CRC receiving regorafenib, encorafenib, or trifluridine + tipiracil, utilizing multiple pharmacies for non-CRC medications was associated with a 29.5% decreased likelihood of optimal adherence compared to those who only utilized one pharmacy. Further examinations are warranted that include other modulators of adherence.
- Stivarga (regorafenib) / Bayer
A phase 2 clinical trial of regorafenib in patients with advanced pretreated melanoma (RegoMel). (Hall A; Poster Bd #: 302) - Apr 24, 2024 - Abstract #ASCO2024ASCO_828;
P2
In BRAF V600 -mutant melanoma, continuation of REGO in combination with BRAF-/MEK-inhibitors demonstrated promising activity in patients who previously progressed on BRAF-/MEK-inhibitors for which further prospective investigation is ongoing. 1.
- Anti-angiogenic TKIs in patients with advanced Ewing sarcoma: A systematic review and single-arm meta-analysis. (Hall A; Poster Bd #: 457) - Apr 24, 2024 - Abstract #ASCO2024ASCO_739;
Anti-angiogenic TKIs are well tolerated and have shown anti-tumoral activity and clinical benefit in the treatment of patients with advanced Ewing sarcoma. Prospective randomized trials with adequate control groups are warranted to further evaluate the benefits of these agents.
- Bavencio (avelumab) / EMD Serono, Stivarga (regorafenib) / Bayer
Reshaping the tumor microenvironment of cold soft-tissue sarcomas with anti-VEGFR targeted therapy: A Phase 2 Trial of Regorafenib combined with avelumab. (S102) - Apr 24, 2024 - Abstract #ASCO2024ASCO_724;
P1/2
The observed efficacy appears superior to that of single-agent immune checkpoint inhibition in 'cold' STS, and higher than the 6-month PFS benchmark of 14% set by EORTC. This indicates the potential effectiveness of this treatment combination in managing advanced cold STS, marking a significant stride in precision immunotherapy for this group of tumors.
- | Nplate (romiplostim) / Amgen, Kyowa Kirin
Journal: Romiplostim as an early treatment for refractory immune thrombocytopenia in a 2-month-old infant. (Pubmed Central) - Apr 24, 2024
This indicates the potential effectiveness of this treatment combination in managing advanced cold STS, marking a significant stride in precision immunotherapy for this group of tumors. No abstract available
- | Ibrance (palbociclib) / Pfizer, Blincyto (blinatumomab) / Astellas, Amgen
Journal, CAR T-Cell Therapy: Palbociclib and chemotherapy followed by blinatumomab consolidation to CAR-T cell therapy in KMT2A-rearranged, therapy-related acute lymphoblastic leukemia. (Pubmed Central) - Apr 24, 2024
No abstract available No abstract available
- | Prolia (denosumab) / Amgen
Journal: Denosumab Decreases Epicardial Adipose Tissue Attenuation in Dialysis Patients with Secondary Hyperparathyroidism and low bone Mass. (Pubmed Central) - Apr 24, 2024
No abstract available Denosumab may reverse EATat and retard CAC progression in dialysis patients with SHPT.
- | Lumakras (sotorasib) / Amgen
Journal: Sotorasib dosing and incremental cost ineffectiveness - implications and lessons for stakeholders. (Pubmed Central) - Apr 24, 2024
Denosumab may reverse EATat and retard CAC progression in dialysis patients with SHPT. No abstract available
- | Stivarga (regorafenib) / Bayer
Journal: Molecular interaction and MD-simulations: investigation of Sizofiran as a promising anti-cancer agent targeting eIF4E in colorectal cancer. (Pubmed Central) - Apr 24, 2024
Showing the Graphical abstract of the complete study. The online version contains supplementary material available at 10.1007/s40203-024-00206-3.
- || Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Clinical, Retrospective data, Journal: The sequential antifracturative treatment: a meta-analysis of randomized clinical trials. (Pubmed Central) - Apr 24, 2024
In general, at 2?years after the switch from anabolic to antiresorptive drugs, a weighted BMD was increased at the lumbar spine, total hip, and femoral neck site. The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture.
- | Journal: Biological treatments in childhood asthma. (Pubmed Central) - Apr 24, 2024
However, the choice of the most appropriate biologics remains a pending issue. On the other hand, to the extent that several of the biologics have been available for a relatively short time, the most robust evidence in terms of efficacy and safety in children is that of omalizumab.
- | Journal: New biologics for food allergy. (Pubmed Central) - Apr 24, 2024
Dupilumab, despite limited success as monotherapy, shows promise as an adjunct for OIT. Careful consideration of treatment goals, patient preferences, and the evolving landscape of biologics will shape future clinical practice, offering allergists an expanded toolbox for personalized food allergy management.
- | Repatha (evolocumab) / Amgen, Astellas
Biomarker, Journal: Evolocumab Treatment in Pediatric Patients With Homozygous Familial Hypercholesterolemia: Pooled Data From Three Open-Label Studies. (Pubmed Central) - Apr 24, 2024
P2/3, P3,
Results from this pooled analysis support guidelines suggesting a trial of PCSK9 inhibitor therapy regardless of estimated residual LDLR function. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01624142, NCT03403374, and NCT02624869.
- | Journal: Role of biologics in severe food allergy. (Pubmed Central) - Apr 24, 2024
Despite the persisting challenges of economic constraints and the need for further safety studies, biologics offer a promising avenue for improving the quality of life for individuals with food allergies. Ongoing research and collaborative efforts are imperative to fully realize the transformative potential inherent in these emerging therapeutic frontiers.
- || Tavneos (avacopan) / Amgen
PK/PD data, Journal: Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug-Drug Interaction of Avacopan in 2 Open-Label Studies in Healthy Participants. (Pubmed Central) - Apr 24, 2024
P1
These findings provide critical insights into the potential drug-drug interactions involving avacopan, which could have significant implications for patient care and treatment planning. (NCT06207682).
- | Journal: Precision care in the treatment of pediatric asthma. (Pubmed Central) - Apr 24, 2024
(NCT06207682). An understanding of underlying immunologic and genetic mechanisms affecting the development of asthma in pediatric patients has resulted in the production of numerous targeted therapies that have led to improvement in lung function and reduced exacerbation burden.
- | Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Journal: Clinical Efficacy of Biosimilar Switch of Adalimumab for Management of Uveitis. (Pubmed Central) - Apr 24, 2024
Amgevita is safe and effective for inflammatory uveitis with non-inferiority to Humira. Significant numbers of patients requested to switch back due to side effects including injection site reactions.
- | ezetimibe / Generic mfg.
New P4 trial: BESAFE: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients (clinicaltrials.gov) - Apr 24, 2024
P4, N=130, Not yet recruiting, Sponsor: University of Salerno
- |||||||||| camizestrant (AZD9833) / AstraZeneca, saruparib (AZD5305) / AstraZeneca
New P3 trial, Metastases: EvoPAR-Breast01: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (clinicaltrials.gov) - Apr 24, 2024
P3, N=500, Not yet recruiting, Sponsor: AstraZeneca
- ||||| rocatinlimab (KHK4083) / Amgen
Enrollment closed, Combination therapy: ROCKET-SHUTTLE: A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (clinicaltrials.gov) - Apr 24, 2024
P3, N=746, Active, not recruiting, Sponsor: Amgen
Significant numbers of patients requested to switch back due to side effects including injection site reactions. Recruiting --> Active, not recruiting
- ||||||| Vectibix (panitumumab) / Amgen
Trial completion, Real-world evidence: Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix (clinicaltrials.gov) - Apr 23, 2024
P=N/A, N=647, Completed, Sponsor: iOMEDICO AG
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || ordesekimab (AMG 714) / Amgen, Sanofi
Enrollment closed, Phase classification, Trial completion date: REVEAL: Evaluation of AMG 714 for Vitiligo (clinicaltrials.gov) - Apr 23, 2024
P2, N=57, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Phase classification: P2a --> P2 | Trial completion date: Sep 2024 --> May 2025
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Observational data, Journal: Comparison of osteoanabolic agents (teriparatide and romosozumab) with bisphosphonates in prevention of subsequent vertebral fractures in patients treated for osteoporotic vertebral fracture for 12 (Pubmed Central) - Apr 23, 2024
Osteoanabolic agents were beneficial in reducing unstable pseudoarthrosis, but were not more effective than bisphosphonates in the development of subsequent domino OVF. A more comprehensive approach to the treatment of osteoporosis is needed to prevent domino OVFs.
- || Clinical, Review, Journal: Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. (Pubmed Central) - Apr 23, 2024
A more comprehensive approach to the treatment of osteoporosis is needed to prevent domino OVFs. The CGRP-targeting therapies should be considered as a first-line approach for migraine prevention along with previous first-line treatments without a requirement for prior failure of other classes of migraine preventive treatment.
- | Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
Journal, IO biomarker: Clinicopathologic features of relapsed CD19(-) B-ALL in CD19-targeted immunotherapy: Biological insights into relapse and LILRB1 as a novel B-cell marker for CD19(-) B lymphoblasts. (Pubmed Central) - Apr 23, 2024
The emergence of CD19(-) B-ALL appears to be associated with complex cytogenetic evolutions. The mechanism of CD19(-) B-ALL relapse under anti-CD19 immune pressure remains to be explored by comprehensive molecular studies.
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta (clinicaltrials.gov) - Apr 23, 2024
P3, N=106, Recruiting, Sponsor: Amgen
The mechanism of CD19(-) B-ALL relapse under anti-CD19 immune pressure remains to be explored by comprehensive molecular studies. Not yet recruiting --> Recruiting
- | Prolia (denosumab) / Amgen
Trial completion, Trial completion date, Trial primary completion date: Denosumab Sequential Therapy (clinicaltrials.gov) - Apr 23, 2024
P4, N=101, Completed, Sponsor: National Taiwan University Hospital
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen
Trial completion, Trial completion date, Surgery: acns0333: Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System (clinicaltrials.gov) - Apr 22, 2024
P3, N=70, Completed, Sponsor: Children's Oncology Group
Recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023 Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024