30 results
Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…
Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…
Primary: Explore the predictive ability of the VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (VSG vs VSP) using as outcome progression free survival. Secondary…
To compare the effect of standard care (Docetaxel monotherapy) versus the combination of Docetaxel with Rhenium-188 HEDP for the treatment of patients with progressive castration resistant prostate carcinoma metastatic tot bone.
Primary: progression-free survival in the GSK1120212-group in comparison with the docetaxel group. Secondary: safety and tolerability, response rate, duration of response, overall survival, PK.
The sequential application of chemotherapy and radionuclide treatment in patients with symptomatic osseous metastasized prostate cancer. Patients with more than one painful osseous metastasis will be randomized between 153Sm-EDTMP or docetaxel 3…
The primary objective is to select one of two platinum strategies to be used in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.
This study investigates the feasibility role of neoadjuvant chemotherapy, consisting of docetaxel (Taxotere), cisplatin and capecitabine (Xeloda) (TCX), and protocolized surgery in localized and/or locally advanced resectable gastric cancer (D1extra…
To evaluate the anti-tumor activity of a docetaxel/carboplatin regimen in patients with refractory or relapsed SCLC. Furthermore to asses the safety profile of the docetaxel/carboplatin combination.In patients who have experienced FN, the efficacy…
Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
Primary: Progression Free Survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.Secondary: Overall response rate, disease control rate, overall survival, safety and tolerability, PK.
Primary ObjectiveTo compare the objective response rate and overall surival of BMS-936558 versus docetaxel in subjects with squamous cell NSCLC after failure of prior platinum-based chemotherapySecondary ObjectivesTo compare the progression-free…
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…
In this study we therefore investigate the influence of prednisone on docetaxel exposure in metastatic prostate cancer patients.
The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy.The key secondary objective is to compare Overall Survival (OS) in patients treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel…
Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
This is a phase III, open-label, multicenter, randomized study to investigate the efficacy and safety of atezolizumab (anti PDL1 antibody) compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer after…