19 results
Primary objective:the primary objective of the study is to evaluate the safety and to define the maximal tolerated dose or the maximal administered dose of CC-486 as a single agent, in combination with CBDCA or ABI-007 in subjects with relapsed or…
Primary Objectives:* To compare overall survival (OS) of patients who receive NKTR-102given once every 21 days (q21d) to patients who receive Treatment ofPhysician*s Choice (TPC) selected from the following list of seven singleagentintravenous…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) in combination with chemotherapy drugs of physician's choice (which includes Nab-paclitaxel, Paclitaxel or…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
Phase ITo determine the toxicity and optimal dose of LDE225 when co-administered with fixed doses of gemcitabine and nab-paclitaxel in patients with advanced and metastasized pancreatic cancer.Phase IITo determine the anti-tumor activity of LDE225…
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…
To investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer.
To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.
Primary Objective:- To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) and pembrolizumab versus treatment of physician*s choice (TPC) and pembrolizumab. Secondary…
Primary Objective- The primary objective of the study is: * to compare DFS between subjects randomized to nabpaclitaxel plus gemcitabine and subjects randomized to gemcitabine alone.Secondary Objectives- The secondary objectives of the study are to…
1) Objective: To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with respect to PFS
Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…
The primary objectives are to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of ABBV-621 and to evaluate pharmacokinetics (PK) of (A) single agent ABBV-621; and (B) the combination of ABBV-621 and venetoclax in…
Study Objective(s):Primary-To compare the overall survival (OS) of subjects with locally advanced or metastatic urothelialcancer treated with enfortumab vedotin (EV) to the OS of subjects treated with chemotherapySecondary-To compare progression-…
Main objective:Dose Escalation Part:• To assess the safety and tolerability of DF1001, and to determine the Maximum Tolerated Dose (MTD) of DF1001 in patients with Advanced (unresectable, recurrent, or metastatic) solid tumors for whom no effective…