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EU Clinical Trial 2018-000399-13 – EMA – Feb 15, 2019

A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced squamous NSCLC (sqNSCLC) harbouring FGFR genetic alterations after relapse of standard therapy

Main objective of the trial: To evaluate the efficacy of erdafitinib in sqNSCLC with FGFR genetic alteration
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EU Clinical Trial 2017-003619-20 – EMA – Feb 14, 2019

Long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes

Main objective of the trial: The primary objective is to assess the long-term effects of treatment with semaglutide compared to placebo, both added to standard-of-care, on diabetic retinopathy development and progression in subjects with T2D
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EU Clinical Trial 2015-005358-36 – EMA – Feb 14, 2019

I8B MC ITRO A Prospective, Randomized, Double Blind Comparison of LY900014 to Humalog in Adults with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Main objective of the trial: To test the hypothesis that LY900014 is noninferior to Humalog on glycemic control ([NIM = 0.4% for HbA1c) in patients with T1D using CSII for 16 weeks
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EU Clinical Trial 2018-003926-10 – EMA – Feb 13, 2019

Prospective comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the initial work-up of Multiple Myeloma

Main objective of the trial: To compare FCH-PET and FDG-PET for the number of bone lesions detected and confirmed by reference test in patients with newly diagnosed MM and not yet treated
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EU Clinical Trial 2017-002154-36 – EMA – Feb 13, 2019

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled Severe Japanese Cedar Pollinosis Despite the Current Recommended Therapies

Main objective of the trial: To demonstrate the efficacy of omalizumab compared with placebo
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EU Clinical Trial 2017-004734-28 – EMA – Feb 13, 2019

Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.

Main objective of the trial: To determine the efficacy (as assessed by best response) of osimertinib in patients with locally advanced or metastatic NSCLC and only an EGFR exon 20 mutation, deletion and/or insertion, which are T790M-ve.
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EU Clinical Trial 2018-004261-14 – EMA – Feb 12, 2019

MUscle Side-Effects of atorvastatin in coronary patients (MUSE)

Main objective of the trial: The primary objective is to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin associated muscle symptoms (SAMS).
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EU Clinical Trial 2018-000911-25 – EMA – Feb 12, 2019

A prospective multicenter open, not controlled phase Ib-II clinical trial to assess the safety and immunologic efficacy of virus-specific T lymphocytes from the best donor in receptors of hematopoietic progenitor allogeneic transplant

Main objective of the trial: 1. To evaluate the safety of ViroTCell administration to the recipient in the post-transplant period 1.Evaluar la seguridad de la administración de ViroTCell tras ser transfundidos al receptor en el periodo postrasplante.
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EU Clinical Trial 2018-003090-95 – EMA – Feb 12, 2019

The Norwegian Tenecteplase Stroke Trial 2 ( NOR-TEST 2 ) Tenecteplase in Acute Stroke 2

Main objective of the trial: Objective of NOR-TEST 2 is to compare efficacy and safety of tenecteplase 0.4 mg/kg (single bolus) vs. alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes) a) within 4½ hours after symptom onset; b) within 4½ hours a...
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EU Clinical Trial 2018-001224-19 – EMA – Feb 11, 2019

Non-invasive in-vivo prediction of therapeutic response to inhibitors of angiogenesis using gallium (68Ga) NODAGA-RGD PET/CT

Main objective of the trial: 1. To compare the response rate to treatment including antiangiogenic agent in patients with advanced metastatic cancer of the colon or rectum , according to whether or not all known lesions, were visually positive on gal...
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EU Clinical Trial 2018-003753-13 – EMA – Feb 11, 2019

Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis

Main objective of the trial: To obtain ≥ 70% of patients with prednisone ≤ 0.1mg/kg per day and inactive disease during 3 months at 6 months after randomization. Proportion at 6 months after randomization of patients with prednisone ≤ 0.1mg/kg per da...
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EU Clinical Trial 2017-003680-35 – EMA – Feb 11, 2019

Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment (PARCT)

Main objective of the trial: To determine the antitumor activity of atezolizumab for patients with refractory or relapsed advanced stages of mycosis fungoides and Sézary syndrome, assessed in terms of the overall response rate, according to EORTC-ISC...
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EU Clinical Trial 2017-003092-55 – EMA – Feb 11, 2019

A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)

Main objective of the trial: The primary objectives are to evaluate: -The effect of inclisiran treatment on the proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study (EOS) -The safety and to...
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EU Clinical Trial 2018-001997-52 – EMA – Feb 11, 2019

A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis.

Main objective of the trial: Part A: • To evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI). Part B: • Part B is an estimation study; no hypot...
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EU Clinical Trial 2018-002573-21 – EMA – Feb 11, 2019

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Main objective of the trial: To compare the efficacy of 100 mg and 200 mg once daily (QD) of PF 04965842 versus placebo in adult subjects on background topical therapy with moderate to severe atopic dermatitis (AD).
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EU Clinical Trial 2018-002239-11 – EMA – Feb 8, 2019

Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients with Stable Heart Failure with Reduced Ejection Fraction

Main objective of the trial: To establish preliminary safety and tolerability of single and multiple ascending oral doses of MYK-491 in ambulatory patients with stable heart failure with reduced ejection fraction (HFrEF).
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EU Clinical Trial 2018-002998-21 – EMA – Feb 8, 2019

A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)

Main objective of the trial: To compare iDFS for ribociclib + ET versus ET in patients with HRpositive, HER2-negative, EBC. Comparar la supervivencia libre enfermedad invasiva (SLEi ) de ribociclib + terapia endocrina (TE) comparado a terapia endocri...
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EU Clinical Trial 2018-003824-35 – EMA – Feb 8, 2019

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) with or without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants with Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

Main objective of the trial: Part 1: To evaluate the safety and tolerability of treatment with lenvatinib + platinum doublet chemotherapy + pembrolizumab. Part 2: To compare PFS as assessed by blinded independent central review (BICR) according to Re...
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EU Clinical Trial 2018-001148-67 – EMA – Feb 8, 2019

Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease

Main objective of the trial: To evaluate the ongoing safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa (PRX-102) every other week in adult Fabry patients who have successfully completed studies PB-102-F20 or PB-102-F30. Ev...
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EU Clinical Trial 2018-002715-10 – EMA – Feb 8, 2019

RANDOMIZED, DOUBLE-BLIND, PILOT CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FISH OIL-BASED INTRAVENOUS LIPID EMULSIONS IN HOSPITALIZED ADULT PATIENTS TREATED WITH TOTAL PARENTERAL NUTRITION WITH HYPERTRIGLYCERIDEMIA

Main objective of the trial: In hospitalized adult patients treated with parenteral nutrition who have hypertriglyceridemia (> 3 mmol / L) after the administration of a lipid emulsion with olive oil/soybean standard at 0.8 g/kg/day, the main objectiv...
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EU Clinical Trial 2017-002370-39 – EMA – Feb 8, 2019

A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

Main objective of the trial: To evaluate PK noninferiority of ravulizumab SC versus ravulizumab IV in adult patients with PNH Evaluar la FC de no inferioridad de ravulizumab s.c. frente a ravulizumab i.v. en pacientes con HPN
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EU Clinical Trial 2018-000349-38 – EMA – Feb 8, 2019

I4V-MC-JAIP A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis

Main objective of the trial: The primary objective of the study is to demonstrate the superiority of each dose of baricitinib to placebo in the treatment of patients with moderate to severe AD. Primary Objective for PK lead-in Period is to assess whe...
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EU Clinical Trial 2018-003042-16 – EMA – Feb 8, 2019

Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft in terms of recurrence during the first year after surgery

Main objective of the trial: To evaluate the efficacy, through the rate of recurrence during the first postoperative year, of the fibrin membrane graft and concentrated eye drops in autologous growth factors in primary pterygium surgery, comparing it...
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EU Clinical Trial 2018-001923-38 – EMA – Feb 8, 2019

Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia

Main objective of the trial: Phase 1: Evaluate the safety of KTE-X19 Phase 2: Evaluate the efficacy of KTE-X19 as measured by the objective response rate (ORR) per independent review Fase 1: evaluar la seguridad de KTE-X19 fase 2: evaluar la eficacia...
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EU Clinical Trial 2018-000058-22 – EMA – Feb 8, 2019

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Main objective of the trial: - Part 1A and Part 1B: To determine the safety, tolerability, DLTs, and MTD of relatlimab administered in combination with nivolumab and BMS-986205 or nivolumab and ipilimumab in participants with advanced malignant tumor...
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EU Clinical Trial 2018-003864-30 – EMA – Feb 8, 2019

A Study to Evaluate the Safety and efficacy of the CD40 Agonistic Antibody APX005M in Adults with Immunotherapy Naive Metastatic Melanoma

Main objective of the trial: Evaluate the overall response rate (ORR) by RECIST 1.1 in immunotherapy naïve subjects with unresectable or metastatic melanoma in each dosing schedule Evaluar la tasa de respuesta global (ORR) según los Criterios de Eval...
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EU Clinical Trial 2018-002261-19 – EMA – Feb 8, 2019

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

Main objective of the trial: Efficacy objectives • To evaluate the efficacy of PRN1008 in achieving durable CR on low to zero doses of oral corticosteroid (CS) and on the timecourse of quantitative disease activity scores • To assess the ability of P...
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EU Clinical Trial 2017-001044-35 – EMA – Feb 8, 2019

Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 months to 17 Years

Main objective of the trial: Immunogenicity - To describe the HAI antibody response induced by QIV in MDV presentation compared with QIV in syringe presentation for the four strains.
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EU Clinical Trial 2017-001459-30 – EMA – Feb 8, 2019

A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

Main objective of the trial: The objective of the trial is to characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia. Caracterizar más en profundidad la seguridad y tolerabilidad a largo plazo de brexpip...
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EU Clinical Trial 2017-005053-37 – EMA – Feb 8, 2019

Effect on the functional capacity of treatment with intravenous iron carboxymaltose or oral iron sucrosomial in patients with heart failure with depressed left ventricular ejection fraction and iron deficiency anemia".

Main objective of the trial: Patients with heart failure with reduced ejection fraction ( HFrEF) and iron deficency. Pacientes con insuficiencia cardiaca (IC) con fracción de eyección del ventrículo izquierdo (FEVI) deprimida y deficit de hierro
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EU Clinical Trial 2018-002614-12 – EMA – Feb 8, 2019

Short-term Effects of Dapagliflozin on Peak VO2 in Patients with Heart Failure with Reduced Ejection Fraction and Type 2 Diabetes

Main objective of the trial: To determine and quantify the changes in peakVO2 at 30 and 90 days after starting treatment with dapagliflozin vs. placebo. Determinar y cuantificar los cambios en el picoVO2 a los 30 y 90 días después de comenzar el trat...
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EU Clinical Trial 2018-001159-11 – EMA – Feb 8, 2019

A multicenter, open-label, sponsor-blinded, randomized, active-controlled, parallel group, pivotal study to evaluate the efficacy, safety, and tolerability of murepavadin given with ertapenem versus an anti-pseudomonal-β lactam-based antibiotic in adult subjects with nosocomial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa.

Main objective of the trial: To demonstrate the non-inferiority (NI) in 28-day all cause mortality (ACM) rate of i.v. murepavadin given with ertapenem compared to an anti-pseudomonal- β-lactam-based antibiotic (either piperacillin- tazobactam or mero...
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EU Clinical Trial 2018-001974-76 – EMA – Feb 8, 2019

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

Main objective of the trial: To compare the recurrence-free survival (RFS), as assessed by the investigator and confirmed by biopsy, in individuals who receive pembrolizumab with individuals who receive placebo as adjuvant therapy Comparar la supervi...
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EU Clinical Trial 2017-002781-48 – EMA – Feb 8, 2019

INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN HORMONE RECEPTOR- POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING FIRST-LINE PALBOCICLIB-BASED TREATMENT.

Main objective of the trial: To compare the efficacy, defined as progression-free survival (PFS), of continuation of palbociclib treatment combined with second-line endocrine therapy (fulvestrant or letrozole) versus endocrine therapy in pre- and pos...
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EU Clinical Trial 2018-000305-23 – EMA – Feb 7, 2019

A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

Main objective of the trial: Proof of Concept (POC) Phase 2 Primary Objective: To demonstrate a superior effect of BOS161721 at the chosen dose compared with placebo for response on the SRI-4.
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EU Clinical Trial 2018-002647-29 – EMA – Feb 7, 2019

A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Main objective of the trial: - to assess the efficacy of fimaporfin induced PCI of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy versus gemcitabine/cisplatin alone in patients with inoperable CCA by assessment of PFS
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EU Clinical Trial 2018-000789-13 – EMA – Feb 5, 2019

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Platin-Resistant Oropharyngeal Cancer (OPC)

Main objective of the trial: Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1...
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EU Clinical Trial 2018-002551-15 – EMA – Feb 5, 2019

A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Main objective of the trial: -To confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM for subjects with CLDN18.2 positive, metastatic pancreatic adenocarcinoma (Safety Lead-in Phase) -To determine antitumor acti...
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EU Clinical Trial 2017-004930-27 – EMA – Feb 5, 2019

Systems medicine analysis of sarcoidosis by targeting mTOR in a pilot study of sirolimus as treatment in patients with sarcoidosis

Main objective of the trial: To demonstrate treatment efficacy of sirolimus as improvement or stabilization of disease in patients with sarcoidosis
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EU Clinical Trial 2018-003072-12 – EMA – Feb 5, 2019

Radiation Therapy Planning by Multi-parametric PET/MRI Imaging in patients with cervical cancer

Main objective of the trial: We study patients with cervical cancer stage IB2-IV during radiotherapy treatment. This is carried out by adding angiogenesis PET scan to the usual MR scan.
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EU Clinical Trial 2018-001279-19 – EMA – Feb 5, 2019

Evaluation of the SONAS® ultrasound device for the assessment of bilateral cerebral perfusion in subjects with acute stroke

Main objective of the trial: To determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.
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EU Clinical Trial 2018-003584-53 – EMA – Feb 5, 2019

A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3

Main objective of the trial: To assess the efficacy of Debio 1347 in terms of ORR in subjects with solid tumors harboring FGFR1-3 gene fusion/rearrangement.
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EU Clinical Trial 2017-003134-85 – EMA – Feb 4, 2019

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Main objective of the trial: To evaluate the clinical activity (as assessed by objective response rate [ORR]) of specific pembrolizumab-based combinations. Evaluar la actividad clínica (determinada mediante la tasa de respuestas objetivas [TRO]) de c...
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EU Clinical Trial 2017-004324-30 – EMA – Feb 4, 2019

A multicenter, randomized, phase II trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally- recurrent or metastatic breast cancer patients after progression on endocrine therapy (REVERT)

Main objective of the trial: The primary endpoint is the overall response rate (ORR) in the arm corresponding to the patients treated with eribulin in combination with aromatase inhibitor therapy (eribulin+ET arm), based on local investigator’s asses...
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EU Clinical Trial 2017-004040-38 – EMA – Feb 4, 2019

An open-label, multi-centre, randomised, switch study to evaluate the virological efficacy over 96 weeks of 2-drug therapy with DTG/RPV FDC in antiretroviral treatment-experienced HIV-1 infected subjects virologically suppressed with NNRTIs resistance mutation K103N

Main objective of the trial: To compare efficacy of DTG/RPV combined tablet versus continued antiretroviral treatment regimen at 48 weeks in individuals with the K103N resistance mutation. Comparar los resultados de la carga viral a las 48 semanas co...
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EU Clinical Trial 2018-001213-32 – EMA – Feb 4, 2019

Effectiveness of olaparib plus trastuzumab in HER2-positive BRCA-mutated or Homologous Recombination Deficiency (HRD) advanced breast cancer patients – The OPHELIA Study –

Main objective of the trial: To assess the efficacy – as determined by the Overall Response Rate (ORR) and Progression-free Survival (PFS) based on RECIST v.1.1 – of olaparib in combination with trastuzumab in patients with HER2-positive, germinal BR...
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EU Clinical Trial 2018-002095-40 – EMA – Feb 4, 2019

Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program.

Main objective of the trial: To evaluate the efficacy of neoadjuvant chemotherapy combination (5FU/LV + Oxaliplatin + nal-IRI) to determine the percentage of clinical responses after neoadjuvant treatment in patients with LARC. Evaluar la eficacia de...
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EU Clinical Trial 2018-002584-25 – EMA – Feb 4, 2019

A phase II study of olaparib in recurrent IDH mutated high grade gliomas OLAGLI

Main objective of the trial: To evaluate the efficacy of olaparib, based on 6 months progression-free survival (PFS6) as assessed by RANO criteria, in patients with recurrent IDHm HGGs.
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EU Clinical Trial 2018-003521-28 – EMA – Feb 4, 2019

Cryotherapy under interventional radiology combined with in situ ipilimumab and a flat dose of Nivolumab in stage IIIB/C melanoma. Prospective proof of concept study.

Main objective of the trial: Pilot study for the targeted destruction of melanoma metastases by an infusion of nivolumab, cryotherapy using interventional radiology (IR) combined with in situ anti-cancer immunotherapy with ipilimumab. Faisabilité d’u...
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EU Clinical Trial 2018-002249-13 – EMA – Feb 4, 2019

SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER

Main objective of the trial: Part 1: Primary objectives are - to evaluate the safety and tolerability of ODM-209; - to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible; - to define the recommended do...
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