12 results
Main study:Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the GLP-1RA versus a single dose prandial insulin onrenal hemodynamics (glomerular filtration rate/ effective renal plasma flow in basal insulin-…
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…
This study is designed as an extension to other veliparib clinical studies. The primary objective of thisstudy is to evaluate the safety and tolerability of veliparib monotherapy, veliparib in combination withcarboplatin/paclitaxel, or veliparib in…
The objective of this study is to evaluate the effect of veliparib on QTcF.
The primary efficacy objectives for this study are as follows:* To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the MCS at W14* To evaluate the efficacy of…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects…
Induction Phase (IP)* To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14)Maintenance Phase (MP)* To…