17 results
Primary objectives:- to assess the safety and tolerability of bolus doses of ABP-700 in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- to optimize bolus dosing of ABP-700 in combination with pre-…
The relative effects of sildenafil on mortality when administered at the three doses indicated above in adults with PAH will be evaluated in this clinical study. In addition, the relative effects on clinical worsening and 6-minute walking distance (…
Primary objectives:- To assess the safety and tolerability of intravenous (IV) infusion doses and infusion dosing methodologies of ABP-700 alone or in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- To…
The main objective is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity (as measured by progression free survival at 12 weeks) in pre-treated patients with metastatic or inoperable locally…
Primary objectives:- to assess the safety and tolerability of a single ascending intravenous (IV) infusion doses of the research medication.- to determine the maximum tolerated dose (MTD) of IV infusion doses of the research medication.Secundary…
Trial objectives* To assess the dose-response relationship, efficacy and safety of ABP-700 for procedural sedation in adult patients undergoing colonoscopy.* To quantify the pharmacodynamic effect of ABP-700 including time to procedure start,…
Primary Objectives: The primary objectives of this study are to evaluate the efficacy and safety of IV sildenafil when added to iNO for the treatment of neonates with PPHN or hypoxic respiratory failure and at risk for PPHN. Secondary Objectives: *…
To evaluate the safety and tolerability of escalating doses of oral sunitinib in combination with standard doses of intravenous ifosfamide in patients with solid malignancies.
Primary objectives:• To assess the safety and tolerability of induction doses of ABP-700 • To optimize induction dosing of ABP-700 in combination with pre-medicationsSecondary objectives:• To characterize the pharmacokinetics (PK) of ABP-700 and its…
PRIMARY OBJECTIVES*Phase 1 Dose Finding Studies:-To determine the recommended phase II dose (RP2D) of new systemic therapy regimens. *Frontline chemotherapy questions:-To compare systemic therapy regimens for patients with VHR disease at diagnosis (…
The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of patients with high risk de-differentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) as…
The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STSprolongs progression-free survival when compared with ifosfamide.Secondary objectives are to evaluate the…
Primary objectives Part A:To test the non-inferiority, as evaluated by OS, of three courses of HDCT compared to focal RT plus conventional chemotherapy as consolidation therapy following conventional chemotherapy in children with ATRT aged 12 - 35…
Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…
Primary objective: To demonstrate pharmacokinetic comparability of 3D-printed sildenafil tablets and the originator sildenafil tablets following a single 20 mg dose in healthy adult subjects.Secondary objectives:• To describe the plasma…
PRIMARY OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle) (AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant GCT (MGCT) of…
To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP regimen (CDCT) with patients treated with high-dose chemotherapy (HDCT) plus ASCT using the TI-CE regimen as…