18 results
Primary objective: To determine the MTD/highest studied dose determined to be safe, the safety and tolerability of INC280 as a single agent when administered orally to adult patients with c-MET dependent advanced solid malignancies.Secondary…
Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…
1) Formulating a dose regimen for intravenous infusion of amoxicillin 1) More insight into the pharmacokinetics of amoxicillin in children of ages making more specific dosing possible.
To examine whether the use of systemically administered antibiotics in therapy resistant Lichen Sclerosus leads to:- Relief of symptoms- Improvement of clinical picture- Improvement of histological abnormalities- Effect on quality of life-…
The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT
The primary objective of the trial is to assess a non-flat dose-response curve and to evaluate the dose-response relationship for 3 oral dose regimens of BI 1291583 versus placebo, on the primary endpoint, time to first pulmonary exacerbation up to…
To evaluate the efficacy of two doses of norucholic acid vs. placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA).
The aim of this phase 2 study is to investigate the safety and efficacy of dazucorilant in the target ALS patient population.
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…
DOSE ESCALATION PHASE: PART A: Primary Objectives: • To assess the safety and tolerability of KBA1412 when given as monotherapy. • To determine the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of KBA1412 when given as…
To assess safety and efficacy of AMX0035 for treatment of ALS.
The trial will assess the efficacy and safety of brigimadlin compared to doxorubicin as first line systemic therapy for advanced or metastatic DDLPS.The primary objective of the trial is to evaluate whether brigimadlin is superior to doxorubicin as…
The purposes of this clinical trial are to:• Test if trial participants taking uproleselan with standard chemotherapy medicines live longer than those taking standard chemotherapy alone. • Test if the number of trial participants achieving disease…
Part 1 of the trial (already completed):The primary objective of the research concerned the determination of the Maximum Tolerated Dose (MTD) and/or Maximum Recommended Dose (MRD) of MCLA-128. Which was set to 750mg.The secundary objective of the…
The primary objective of this feasibility study is to investigate the detection rate of SLNs using MR lymphography.
To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled for parotidectomy and elective neck dissection.
Primary Objective:• To determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I)• To assess the antitumor…
The primary objective of this trial in CIAS is to assess the efficacy in improving cognitive impairment using MCCB in patients with schizophrenia treated for 26 weeks with Iclepertin 10mg as compared with placebo.