National University Hospital, Singapore — Biomedical Watch V2

Traitements7programmes

Essais3liés

Publications5liées

SourceDBlocale

Traitements

7

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
AZD9291Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR sensitizing mutations and T790M detected in plasma ctDNA. This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 106 subjects will be enrolled. All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.	Cancer	Phase 2	Ralentissement de la progression	Hong Kong, Singapore, South Korea, Taiwan, Thailand	À vérifier
Descovy® (TAF/FTC)Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD. This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets. This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention. This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers. Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period. The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.	Alzheimer	Phase 1	Ralentissement de la progression + Immunomodulation	Singapore	À vérifier
Dose escalated, accelerated, hypofractionated radiotherapyLocally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low. This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome. This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.	Cancer	Phase 2	À vérifier	Singapore	À vérifier
Emtricitabine (FTC)Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD. This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets. This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention. This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers. Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period. The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.	Alzheimer	Phase 1	Ralentissement de la progression + Immunomodulation	Singapore	À vérifier
AZD9291Circulating tumor DNA (ctDNA) is a highly specific and effective biomarker for the detection of EGFR mutation status. We hypothesise AZD9291 is efficacious in patients with EGFR sensitizing mutations and T790M detected in plasma ctDNA. This is a prospective, open label, multi-centre single arm phase II study assessing the efficacy and safety of AZD9291 monotherapy in patients with stage IIIB or IV harboring sensitising EGFR mutation (exon 19 deletions or exon 21 L858R substitution mutations) and T790M who have progressed following prior treatment with an approved EGFR TKI. Approximately 106 subjects will be enrolled. All patients must have documented radiological progression on EGFR-TKI treatment and on the last treatment administered prior to enrolling in the study.	Cancer	Phase 2	Ralentissement de la progression	Hong Kong, Singapore, South Korea, Taiwan, Thailand	À vérifier
Dose escalated, accelerated, hypofractionated radiotherapyLocally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low. This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome. This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.	Cancer	Phase 2	À vérifier	Singapore	À vérifier
Emtricitabine (FTC)Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD. This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets. This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention. This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers. Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period. The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.	Alzheimer	Phase 1	Ralentissement de la progression + Immunomodulation	Singapore	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
Emtricitabine (FTC)	Alzheimer	Phase 1	NCT07210528	SONATAS — Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study	ACTIVE_NOT_RECRUITING
Dose escalated, accelerated, hypofractionated radiotherapy	Cancer	Phase 2	NCT00938418	Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer	UNKNOWN
AZD9291	Cancer	Phase 2	NCT02811354	Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected in Plasma Ct-DNA	UNKNOWN

Publications

5

Molécule	Indication / population	Titre	Journal	Date
Dose escalated, accelerated, hypofractionated radiotherapy		Carbon-ion radiation therapy for prostate cancer.	International journal of urology : official journal of the Japanese Urological Association
Dose escalated, accelerated, hypofractionated radiotherapy		Lattice Radiation Therapy Delays Progression and Extends Survival for Dogs with Macroscopic Soft Tissue Sarcoma.	Radiation research
AZD9291		Sphingosine-1-Phosphate Receptor 3 Confers Tumor Metastasis in Lung Cancer Resistant to Third-Generation EGFR Inhibitor.	MedComm
AZD9291		Osalmid inhibits lung adenocarcinoma progression and enhances EGFR-TKI responses: a preclinical and translational study.	Translational lung cancer research
AZD9291		Chitosan-based nanotheranostics integrated dual-modal imaging and combinatorial tumor therapy for EGFR-TKI resistance reversal.	Materials today. Bio