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The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Primary Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition toplatinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum andetoposide (Arm B) in subjects with newly…

A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib
(AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with
Placebo in Combination with Dacarbazine as First Systemic Therapy in
Patients with Metastatic Uveal Melanoma (SUMIT)

ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

The primary objective of this study is to compare PFS of ramucirumab in combination with capecitabine (or 5-fluorouracil [5-FU]) and cisplatin versus placebo in combination with capecitabine (or 5-FU) and cisplatin as first-line treatment in…

A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus CVP vs. MabThera® plus Cyclophosphamide,
Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma

*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…

A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

Primary Objective* The primary objective of this study is to compare the confirmed objective response rate (ORR) by Week 19 following treatment with bevacizumab-Pfizer in combination with paclitaxel and carboplatin to bevacizumab-EU plus paclitaxel…

A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

Primary Objective:To determine the effect of the Topical Gentamicin-Collagen Sponge (gentamicin-sponge) in combination with systemic antibiotic therapy compared to placebo-sponge and no-sponge, both in combination with systemic antibiotic therapy on…

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the
efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with
chronic lymphocytic leukemia following first-line therapy

To compare the efficacy and safety of lenalidomide versus placebo maintenance therapy (standard care).

Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized study.

Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

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), *…

LUME-Meso: Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed / cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma

To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…

Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or
Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

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…

A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

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…

A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…

Anamorelin HCl in the Treatment of
Non-Small Cell Lung Cancer - Cachexia (NSCLC-C):
A Randomized, Double-Blind, Placebo-Controlled,
Multicenter, Phase III Study to Evaluate the
Safety and Efficacy of Anamorelin HCl
in Patients with NSCLC-C

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…