22 results
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…
We propose a phase II study (intervention) in patients with severe generalized recessive dystrophic EB receiving reduced toxicity conditioning chemotherapy followe by cord blood transplantation with co-infusion of mesenchymal stromal cell units.…
Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…
Primary:To determine the response rate and response quality of dasatinib monotherapy or dasatinib/fludarabine combination in fludarabine refractory CLL patientsSecundaryTo asses the overall safety profile of this treatment approachTo asses event…
The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90…
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
The primary objective of this study is to determine the excretion balance and to elucidate the metabolic pathway of eribulin in vivo after a single dose of carbon-14 radio-labeled eribulin (14C-eribulin), inpatients with advanced solid tumors.
The main objective of this treatment protocol is to study the efficacy on the treatment response after adding a single gift of Mylotarg. Furthermore, monitoring of toxicity and long term efficacy is also important.
Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…
Primary Objective:To evaluate the efficacy of LN-145 measured by objective response rate (ORR) usingResponse Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by theIndependent Review Committee (IRC) for Cohorts 1 and 2 and by the…
Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…
To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
Primary:• To evaluate the safety and tolerability of autologous genetically modified T-cells (GSK3377794) in human leukocyte antigen (HLA) HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive participants with NY-ESO-1 and/or LAGE-1a positive…
Primary:To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02-positive participants with NY-ESO-1 and/or LAGE-1a positive…
Primary objective: To determine the efficacy of the combination of acalabrutinib and venetoclax without obinutuzumab (AV; Arm A), or with obinutuzumab (AVG; Arm B) compared with chemoimmunotherapy (fludarabine/cyclophosphamide/rituximab [FCR]/…
Primary:To evaluate the efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors.Secondary:To…
The primary objective of the randomized part of the protocol is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non…
The primary objective of the study is the following:• To characterize the safety and tolerability of DNL310 in pediatric subjects with MPS II (all cohorts)The secondary objectives of the study are as follows:• To characterize the CNS effects of…
Stratum 1:To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu) results in a non inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte…