18 results
Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…
To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies.The primary efficacy endpoint of this study is * Overall survivalThe secondary efficacy endpoints of this…
Part 1 (open-label, 8 week): safety and tolerability of eltrombopag, optimal dose escalation scheme for use in Part 2, PK.Part 2: Primary: the reduction in the number of clinically relevant thrombocytopenic events (*Grade 3 hemorrhagic adverse…
To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.
Primary objectives* To assess the tolerability of regorafenib combined with paclitaxel.Secondary objectives* To assess the effect of regorafenib on uptake of paclitaxel in OGC metastases.* To assess the effect of regorafenib on regorafenib targets…
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
The main goal of the current project is to adapt an existing stress reduction intervention (an e-health application) to the needs of women with a lower educational level and/or low SES, to enrich it with additional smoking cessation components, and…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib.
To provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.
The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.
- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
The purpose of this study is to determine if the combination of relatlimab and nivolumab improves overall survival (OS) in all randomized participants and participants with PD-L1 CPS >= 1 with later-line metastatic colorectal cancer compared…
General aim; To dertemine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety to warrant further evaluation as a first line treatment for metastatic GIST.
The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line eltrombopag in adults with primary immune thrombocytopenia