29 results
To perform a pilot study to determine the feasibility of conducting a two-arm phase I trial and to determine the recommended dose level for phase II (RP2D) study and assess the safety of the combination olaparib and melphalan in patients with…
Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…
Objective of the study is the comparison of two previously developed computeralgorithms for the artificial pancreas (closed loop). One algorithm developed by a researchgroup in Cambridge UK, and an algorithm developed by research groups in Padua and…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
To define the maximal tolerated dose (MTD) of olaparib in combination with radiotherapy of the breast and regional lymph nodes in patients with breast cancer without the use of skin bolus (arm A) or with the use of skin bolus (arm B).
Primary study aim:To determine the efficacy, in terms of the meadian progression-free survival, in patients with recurrent or metastatic endometrial cancer (including carcinosarcoma of the endometrium) receiving treatment with durvalumab and…
This research study is designed to check whether olaparib is also effective in treating ovarian cancer which does not have a germline deleterious BRCA mutation, and whether olaparib causes any side effects.A tablet formulation of olaparib is being…
Primary: To determine whether the outcome of the RAD51 assay (HR proficient or HR deficient) correlates with objective response rate (RR) of olaparib, in patients with recurrent high grade epithelial ovarian cancer.Secondary:• Compare the…
To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.
Part 1: Determine the Recommended Phase II Dose
To assess the safety and tolerability of adjuvant treatment with olaparib
Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of rPFS (Radiographic progression-free survival) in patients with mCRPC (Metastatic castration-resistant prostate…
The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.
To define the maximal tolerated dose (MTD) of olaparib in combination with radiotherapy in laryngeal and oropharyngeal SCC.
To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…
Primary objective: to define the maximal tolerated dose (MTD) of Olaparib in combination with high dose radiotherapy with and without daily dose cisplatin in locally advanced non-small cell lung carcinoma.
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
Primary objective To investigate the safety and tolerability of CCS1477 as monotherapy and in combination.
The main objective is to determine the efficacy of Lyumjev in the Inreda AP system. Secondary objectives are: to assess safety, differences in pharmacodynamics and differences in AP-related outcome measures.
The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: • to assess the safety of the closed-loop system; • to determine the time that the closed-loop…