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A global, randomized, placebo-controlled phase 3 study of fruquintinib in patients with refractory metastatic colorectal cancer

ABSTRACT: Interventions: Safety Lead-in Cohort: Fruquintinib will be administered 5 mg orally QD 3 weeks on/1 week off for every 4- week treatment cycle Main study: Fruquintinib (or Placebo) capsule 5 mg will be administered PO, QD, 3 weeks on, 1 week off (4-week cycles). Primary outcome(s): Safety Lead-in Cohort: evaluation of the safety and tolerability of fruquintinib in Japanese patients with mCRC by assessing treatmentemergent adverse events, serious adverse events (SAEs), dose-limiting toxicities (DLTs), deaths, laboratory abnormalities, and other safety data. Main study: OS, defined as the time (months) from date of randomization to death from any cause. Study Design: randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose

DISEASE(S): Refractory Metastatic Colorectal Cancer

PROVIDER: 2613383 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Ropinirole hydrochloride identified by iPSC drug discovery for amyotrophic lateral sclerosis: a single-centered, randomized, double-blind, placebo-controlled phase 1/2a trial

Project description:We assessed the safety and efficacy of ropinirole, a candidate drug for amyotrophic lateral sclerosis (ALS) identified using induced pluripotent stem cells (iPSCs) technology, by a randomized controlled trial (UMIN000034954). Twenty participants were randomly assigned to ropinirole or placebo for 24 weeks in the double-blind period, followed by a 24-week open-label active extension period. Primary outcomes were safety and tolerability. Secondary outcomes evaluated the therapeutic effects of ropinirole. Adverse events were mostly those previously reported, with similar rates in both groups. Participants in the ropinirole group had lived an additional 27.9 weeks without disease progression compared with the placebo group at 12 months. We validated and confirmed the efficacy of ropinirole in patients with ALS using the largest publicly available real-world registry database of ALS (PRO-ACT). The iPSCs-derived motor neurons from the participants showed the D2R expression and the potential involvement of the SREBP2-cholesterol synthetic pathway in the therapeutic effects.

2023-06-30 | GSE209696 | GEO

Butyrate producers as potential next-generation probiotics: safety assessment of the administration of Butyricicoccus pullicaecorum to healthy volunteers

Project description:Advances in gut microbiota research have triggered interest in developing colon butyrate producers as niche-specific next-generation probiotics, targeted at increasing colon butyrate production and countering disease-associated microbiota alterations. Crucial steps in the development of next-generation probiotics are the design of formulations with a reasonable shelf life as well as the safety demonstration of an intervention in healthy volunteers. One such potential next-generation butyrate-producing probiotic is Butyricicoccus pullicaecorum 25-3T, with demonstrated safety in in vitro as well as in animal models. Here, we examined the strain's safety, tolerability, and impact on microbiota composition and metabolic activity in healthy volunteers in a randomized, double blind, placebo-controlled, crossover study in 30 healthy volunteers. Study design consisted of two four-week intervention periods (108 CFU B. pullicaecorum [treatment] or maltodextrin [placebo] per day) with a three-week washout in between. We assessed adverse events, blood parameters (primary endpoints), and fecal microbiota composition and metabolite profiles (secondary endpoints).The number of reported adverse events during the B. pullicaecorum treatment was similar to placebo intervention, as were observed changes in blood chemistry parameters, bowel habits, and fecal calprotectin concentrations. Administration of the strain did not induce any disruptive effect in microbiota composition or metabolic activity. In this first human intervention trial with a butyrate-producing Clostridium cluster IV isolate, we demonstrated B. pullicaecorum 25-3T administration to be both safe and well tolerated by healthy participants. This safety study paves the way for the further development of the strain as a next-generation probiotic.

| EGAS00001003276 | EGA

A Phase 2 Randomized, Double-blind Pilot Study of IL-17-Targeting with 2 Secukinumab in Moderate-to-Severe Atopic Dermatitis

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Mouse femur LC-MSMS upon weightlessness

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2018-12-11 | PXD010114 | Pride

RNA sequencing of sputum cells from a phase IIa placebo controlled clinical trial of Risankizumb in severe asthma

Project description:Interleukin (IL)-23 is implicated in T2 and T17-mediated airway inflammation, supporting a role in asthma. We undertook a Phase II, randomized, double-blind, placebo-controlled, 24-week, parallel-group, multicenter trial to assess the efficacy and safety of risankizumab, an IL23p19 monoclonal antibody, administered subcutaneously (90 mg 4 weekly) in adults with severe asthma. Sputum samples were collected at several timepoints: visit 1B (week -3), visit 2 (week 0 proir to treatment), visit 7 (week 20), visit 8 (week 24, end of treatment), visit 12 (week 40, end of observation). RNA sequencing of sputum cells.

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PD-L1 blockade in combination with inhibition of MAPK oncogenic signaling in patients with advanced melanoma

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2020-09-24 | GSE158403 | GEO

The role of topical containing camellia sinensis in the cosmetic management of skin scars in healthy human volunteers: part 2

Project description:Epigallocatechin-3-gallate (EGCG), a polyphenol, influences cutaneous wound healing due to its anti-angiogenic, anti-inflammatory and anti-oxidant properties. We previously showed EGCG is effective in improving skin scarring when applied immediately post-injury. Here, this double-blinded randomized placebo-controlled trial compared the effects of pre-emptive priming versus immediate and delayed topical EGCG compared with placebo. This was evaluated in 40 healthy human volunteers, over 8 weeks, in scars created in their upper inner arms using skin punch biopsies. Participants were split into 4 groups; each undergoing different modes of application versus placebo: Group 1=priming (7D) pre-injury, Group 2=priming (3D) pre-injury, Group 3=immediate (0D) day-of-injury, Group 4=delayed application (14D) post-injury. RNA sequencing was used here based on 72 samples: Group 1: day 0 (n=3 placebo, n=3 EGCG), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG); Group 2: day 0 (n=3 placebo, n=3 EGCG), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG), Group 3: day 0 (n=6), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG), Group 4: day 0 (n=6), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG). The common differentially expressed genes identified between treated (EGCG) and placebo samples were grouped according to time point and group. Further exploration of these genes using Gene Ontology and Ingenuity Pathway Analysis revealed gene signatures of relevant biological processes and pathways. Here, RNA sequencing revealed a number of angiogenic, inflammatory genes that were significantly downregulated with EGCG particularly in pre-emptive priming Group 1 at week 4 including; hemoglobin subunit beta (HBB), hemoglobin subunit alpha-1 (HBA1) and hemoglobin subunit alpha-2 (HBA2) at week-4.

2020-12-01 | GSE152781 | GEO

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Long-Term Safety of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain

Project description:Primary objectives: To compare alvimopan with placebo for long-term safety and tolerability Primary endpoints: Incidence of reported clinical adverse events, including serious and non-serious adverse events as well as treatment-limiting adverse events

| 2517464 | ecrin-mdr-crc

The role of topical containing camellia sinensis in the cosmetic management of skin scars in healthy human volunteers

Project description:Epigallocatechin-3-gallate (EGCG), a polyphenol, influences cutaneous wound healing due to its anti-angiogenic, anti-inflammatory and anti-oxidant properties. We previously demonstrated the role of EGCG in scarring in ex vivo human scar models. A double-blind randomised-controlled trial. Here, we evaluated application of topical EGCG compared with placebo in 62 healthy human volunteers, over 8 weeks, in scars created in their upper inner arms using skin punch biopsies. RNA sequencing was used here based on 45 samples: day 0 (n=3), week 1 (n=3 placebo, n=3 EGCG), week 2 (n=3 placebo, n=3 EGCG), week 3 (n=3 placebo, n=3 EGCG), week 4 (n=3 placebo, n=3 EGCG), week 5 (n=3 placebo, n=3 EGCG), week 6 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG). The common differentially expressed genes identified between treated (EGCG) and placebo samples were grouped according to time point (Zonal priming: weeks 1 and 2; Direct application post scar formation (2 weeks post-biopsies): weeks 1, 2, 3, 4, 6). Further exploration of these genes using Gene Ontology and Ingenuity Pathway Analysis revealed gene signatures of relevant biological processes and pathways. Here, RNA sequencing revealed a number of angiogenic, inflammatory and antioxidant genes that were significantly downregulated with EGCG particularly at week 1 including; TPSAB1, VEGFA, EDF, IL17F, IL1A, IL1RL1, IL36A, IL36G, SOD3.

2019-05-01 | GSE124161 | GEO

A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)

Project description:Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy

| 2180115 | ecrin-mdr-crc

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