15 results
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
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…
The objective of this study is to evaluate the effect of veliparib on QTcF.
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
To determine if there is a difference in the pharmacokinetics of low-dose cisplatin with and without prehydration.
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
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…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
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 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 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 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…
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…