18 results
Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…
Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…
Primary: to characterize the safety and tolerability of GSK3052230 in combination with chemotherapy regimens, to determine the MTD and to assess overall response rate in patients with stage IV or recurrent squamous NSCLC with FGFR1 gene…
Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…
The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…
The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…
To evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…
Primary objectives1. To assess in a randomized comparison the effect of Ibrutinib added to 10-day decitabine treatment on the cumulative CR/CRi rate after 3 cycles.Secondary objectives1. To assess the safety and tolerability of Ibrutinib added to 10…
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
Primary objectivesTo compare overall survival for MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A to atezolizumab in combination with the background therapy of etoposide/platinum followed by…
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…
Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the cumulative CR/CRi rate during 3 cycles.Secondary objectives:- To assess the safety and tolerability of midostaurin added…