11 results
A complete list of objectives is presented in Section 2.1 Objectives of the Study Protocol. In summary, the primary objective of this study is to demonstrate a superior LDL-C lowering effect of PF 04950615 150 mg administered by the SC route Q2wks…
PRIMARY OBJECTIVE:- To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.SECONDARY OBJECTIVE: - To describe overall survival and treatment related mortality of 24 months…
A complete list of the study objectives is presented in the Objectives section of the protocol. In summary, the primary objective of this study is to demonstrate a superior LDL-C lowering effect of PF-04950615 150 mg administered by the SC route…
The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…
The aim of the trial is to individualize treatment for each patient by adapting it to early response and to treat only those patients with addiotional radiotherapy who show an inadequate treatment response. The degree of treatment response is…
Primary:• Phase I part: to define the recommended dose (RD) of nilotinib and vinblastine when used in combination• Phase II part: to evaluate the efficacy of vinblastine in combination with nilotinib (VINILO) at the RD, as compared to vinblastine…
To evaluate whether the efficacy in terms of progression free survival (PFS) of second-line tepotinib in combination with gefitinib is superior to pemetrexed+cisplatin/carboplatin in subjects with T790M negative, MET+ locally advanced or metastatic…
The aim of this trial is to individualize and thus to optimize treatment for each patient by adapting it to the individual response. The treatment response is determined by means of FDG-PET after 2 cycles of escalated BEACOPP + 2 cycles of ABVD.The…
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET results in improved efficacy while minimizing treatment toxicity in advanced stage HL patients treated with BV-containing regimens, BrAVD and…
Primary objective:To improve the PET negativity after two cycles of immuno-chemotherapyPrimary efficacy endpoint:PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.…
PART 1Cohort A (METex14 skipping alterations):• To assess the efficacy of tepotinib in subjects with locally advanced or metast. (NSCLC), harboring the METex14 skipping alterations or MET amplif., as per objective response acc. to RECIST v.1.1,…