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A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma (CTCL)

The main purpose of this study is to determine if KW-0761, an investigational drug will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

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…

Phase III Randomized Double-blind Cross-over trial of Supersaturated Calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of Oral Mucositis in patients receiving Targeted Therapy

To assess the effect of Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry…

A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN*S LYMPHOMA GRADES 1, 2 OR 3A

To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities.

The primary objective of the study is to demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in…

BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine.

Primary objective:To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E…

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation

Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Primary: To demonstrate the superior efficacy of Nasalfent in the treatment of BTCP in opioid tolerant subjects who are receiving regular opioid therapy.Secondary: To demonstrate the safety, tolerability, and acceptability of Nasalfent in the…

Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHance with Magnevist in Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast.

Primary Objective: To show superiority of a 0.1 mmol/kg dose of MULTIHANCE over a 0.1 mmol/kg dose of MAGNEVIST for breast MRI in terms of sensitivity for the diagnosis of malignant lesions compared with histopathology. Secondary Objectives: a)To…

Multicenter, randomized, open-label, clinical study on the agreement of Scintimun® Granulocyte and labeled 99m Tc-White Blood Cells in diagnosing infection/inflammation by immunoscintigraphy in peripheral bone and joints with suspected osteomyelitis.

The primary objective of the present study is to assess the agreement rate of Scintimun® Granulocyte and 99mTc-WBCs with regard to the diagnosis of infection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and…

A Multicentre, Randomized, Double-Blind, Double Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects with Malignancies

To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignicies who are taking a stable dose of background opioids.

The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial.

(1) investigating the influence of modafinil on fatigue, cognitive functioning, and quality of life of LGG patients, (2) assessing the correlation between (changes in) fatigue, cognition, and quality of life on the one hand, and functional…

A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

To assess the safety and efficacy, measured as progression free survival, of AZD9291 compared with platinum-based doublet chemotherapy in patients with EGFR mutation positive en T790M mutation positive, locally advanced or metastatic non small cell…

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).

Primary Objective1. To evaluate the antitumor activity of pembrolizumab in combination with chemotherapy compared with saline placebo in combination with chemotherapy using PFS per RECIST 1.1 as assessed by BICR of imaging.2. To evaluate the…

DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial*

This study has been transitioned to CTIS with ID 2024-517846-32-00 check the CTIS register for the current data. To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on PFS and ORR in subjects with RAI-refractory DTC who have progressed after prior VEGFR-targeted therapy.