25 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…
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…
The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…
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…
The documentation of safety and performance of silicone oil as temporary tamponade in retinal surgery.
Primary objective To investigate the safety and tolerability of CCS1477 as monotherapy and in combination.
To determine the efficacy of olaparib versus placebo on progression free survival (PFS).
1) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…