Sidi Belabbes, Algeria
- Featured
Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Phase
2Span
139 weeksSponsor
Horizon Therapeutics Ireland DACTokyo
Recruiting
- Featured
- Featured
Study of INCB123667 in Subjects With Advanced Solid Tumors
Phase
1Span
213 weeksSponsor
Incyte CorporationTokyo
Recruiting
- Featured
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
Phase
1Span
269 weeksSponsor
Incyte CorporationTokyo
Recruiting
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Phase
2Span
135 weeksSponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyChuo-ku
Recruiting
Chuo-ku
Recruiting
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
This is a multicentre, Phase III, randomised, open-label study to investigate the efficacy and safety of savolitinib administered orally in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy. Approximately 324 participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC will be randomly assigned to study intervention with 1:1 ratio. Patients will be treated until either objective progression of disease (PD) by Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.
Phase
3Span
229 weeksSponsor
AstraZenecaChuo-ku
Recruiting
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.
Phase
3Span
432 weeksSponsor
AstraZenecaChuo-ku
Recruiting
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Phase
2Span
322 weeksSponsor
AstraZenecaChuo-ku
Recruiting
A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Phase
1Span
307 weeksSponsor
AstraZenecaChuo-ku
Recruiting