32 results
To evaluate the radiologic progression-free survival (PFS) of subjects treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in subjects with metastatic soft tissue sarcoma (mSTS)Secondary Objectives:* To…
The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…
Primary Objectives:* To compare overall survival (OS) of patients who receive NKTR-102given once every 21 days (q21d) to patients who receive Treatment ofPhysician*s Choice (TPC) selected from the following list of seven singleagentintravenous…
The purpose of this study is to assess the effectiveness of extended treatment with CC compared to treatment with gonadotropins and/or the use of intra-uterine insemination (IUI), in patients who had six ovulatory cycles after CC, but did not…
Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to placebo in addition to background therapy with long acting B2 agonist/ inhaled corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough FEV1 after 26 weeks…
Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…
Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.Phase II part 1) To investigate the proportion of patients…
The primary objective of the Phase 2 part of the study is to determine if overall survival(OS) in patients with Stage II-IV unresectable pancreatic cancer administered LY2603618 and gemcitabine combination therapy exceeds gemcitabine monotherapy OS.…
The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.
To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.
Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…
The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…
The primary objectives of the study are:- to establish the optimal dose of the combination for second-line therapy with NAMI-A and Gemcitabine (Phase I part)- to assess the response rate according to RECIST criteria (Phase II part) in advanced NSCLC…
Primary objective: To evaluate the safety of Gemcitabine and Lapatinib in combination for the treatment of advanced breast cancer.Secondary objectives: Assessment of the effect of Gemcitabine and Lapatinib on the pharmacokinetics of each other and…
primary • To determinne the safety and tolerability of sorafenib when administered in combination with gemcitabine and carboplatin.• To determine the maximal tolerated dose (MTD), dose limiting toxicity (DLT) and optimal treatment schedule of…
To assess the response rate to the combination of gemcitabin plus oxlaiplatin in 5 different strata of relapsed/refractory pediatric solid tumors, in whom standard treatment has failed. Secondary objectives are the safety, the duration of response,…
The primary objective is to investigate the safety and tolerability of inhalation of glycopyrronium inhalation powder using different dosing regimens. The second objectives are to determine the decrease in drooling by using different dosing regimens…