Baignes Ste Radegonde, France

  • Featured

    Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

    Phase

    2

    Span

    227 weeks

    Sponsor

    Mirati Therapeutics Inc.

    A Coruña, A Coruña

    Recruiting

  • Featured

    A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

    Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

    Phase

    3

    Span

    Sponsor

    Santiago de Compostela, A Coruna

    Recruiting

  • Impact of Amyloidosis on TAVI Patients

    Type and design of the study: Multicentric, prospective cohort, observational. Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS. Duration of the study - Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis. - Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months. Inclusion: 1 year Follow up: 2 years Data analysis: 6 months Total: 3 years and 6 months Events - Main event: cardiovascular events (cardiovascular death, stroke, infarction) - Secondary events: death from any cause, readmission due to heart failure, pacemaker implantation, functional class evaluation Countries and participating centers: Various Spanish and international centers will be invited to participate.

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    Javier López Pais

    Santiago de Compostela, Galicia

    Recruiting

  • A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

    This study will consist of a Core Study, Extension Phase A and Extension Phase B. 1. Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks). 2. Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study. 3. Extension Phase B will only be for participants who reside in countries where perampanel (oral tablets or oral suspension) is not commercially available or an extended access program (EAP) is not yet implemented, participants have completed Extension Phase A, and who, in the opinion of the investigator, will continue to benefit from treatment with perampanel.

    Phase

    2

    Span

    395 weeks

    Sponsor

    Eisai Inc.

    Santiago de Compostela

    Recruiting

  • Registry for Patients With Lipodystrophy

    As lipodystrophies are rare diseases subdivided into yet rarer sub-groups, research in this field requires international co-operation. The European Consortium of Lipodystrophy (ECLip) consists of an association of European experts in the field of lipodystrophy. It has set up a Registry Board to implement a registry for patients with lipodystrophy using the Open Source Software OSSE (Open Source Registry System for Rare Diseases in the EU), which is a web based platform focused on a federated approach that allows to perform distributed searches which are designed to comply data protection requirements and preserve data sovereignty. To ensure data protection, medical and identifying data will be stored on two different servers both run by the Institute for Epidemiology and Medical Biometry of the University of Ulm. Medical centers from all over the world where patients are treated with lipodystrophy are invited to join the ECLip Registry and to become ECLip Registry members. Upon registration, they can enter patient data after they have obtained local ethic committee permission and the patient in question has given written consent to this. Data entry is done at the individual locations via a web-based user interface. Identifying data are recorded directly into the identity management system. Communication between the identity management and the OSSE registry happens via a web browser. The aim of the patient registry is to compile data on the natural history of each different sub-group of lipodystrophies, their comorbidities, treatment options used and medical and quality of life out-come for the patients. For this, the following data retrieved from regular patient visits are collected: - Precise diagnosis including moleculargenetic results - Clinical presentation and comorbidities - Laboratory changes and results of diagnostic procedures - Natural course of the disease including age at onset of disease and comorbidities - Family history Research within this registry can be performed by participating clinicians/researchers and third parties after a research proposal has be accepted by the responsible committee of the ECLip. The registry aims to answer the following questions - new insights into the pathophysiology of lipodystrophy - improve therapeutic options for the patients - compile information material for patients, families and relevant professionals

    Phase

    N/A

    Span

    2616 weeks

    Sponsor

    University of Ulm

    Santiago de Compostela

    Recruiting

  • A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation

    Phase 1 (dose escalation) will determine the recommended Phase 2 dose (RP2D) (i.e. the lowest dose of Enzomenib (DSP-5336), that provides the maximum biologic and clinical effect, or the MTD, whichever is lower) in adult patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage. Enrollment to the phase 1 portion of the study may be limited to patients with certain genetic abnormalities. Phase 2 dose-expansion will further evaluate the safety and clinical activity of Enzomenib (DSP-5336) monotherapy in patients with relapsed/refractory AML who have MLLr or NPM1m, and relapsed/refractory ALL who have MLLr.

    Phase

    1/2

    Span

    296 weeks

    Sponsor

    Sumitomo Pharma America, Inc.

    Santiago de Compostela

    Recruiting

  • Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients

    This is a multicenter, open label clinical trial evaluating the safety of the combination of belantamab mafodotin + the combination treatment VRd (bortezomib, lenalidomide, dexamethasone) in newly diagnosed (ND) transplant eligible multiple myeloma (MM) patients. The study comprise the following phases: Induction: Cycles 1-6 Cycles will be of 8 weeks of duration for belantamab mafodotin and 28 days of duration for VRd: - Belantamab mafodotin will be administered at the dose of 2.5 mg/kg/every 8 weeks on day 1, intravenously. - Bortezomib will be given subcutaneously, at 1.3 mg/m2, on days: 1, 4, 8 and 11 of every 28-day cycle. - Lenalidomide will be given as an oral drug, in the dose of 25 mg/day on days 1-21. - Dexamethasone will be given as an oral drug, in the dose of 20 mg on days: 1, 2, 4, 5, 8, 9, 11 and 12. Peripheral stem cell harvest will be performed after the fourth cycle of treatment to prevent mobilization failure. Intensification with high-dose melphalan (200 mg/m2) and autologous stem cell transplant (ASCT) will be performed as per routine practice. Mobilization of hematopoietic stem cells (HSCs) will be carried out using high-dose G-CSF after the fourth induction cycle with VRd. The dose of G-CSF used will be at the discretion of each site according to the local rules. Apheresis will be initiated on day 4-5 of stimulation, once the number of CD34+ cells in peripheral blood have reached the minimum to proceed with the collection. The minimum number of CD34+ cells needed to carry out the transplant will be determined at the discretion of each site, although a minimum of 2 x106 CD34+/Kg is recommended, as well as cryopreservation, storage, defrosting and infusion of HSCs. If mobilization fails using G-CSF alone, the recommended action is to utilize plerixafor during the same procedure in order to save this time. Sites should administer plerixafor in accordance with their own established procedures. If this second attempt fails, the site can proceed to a third mobilization attempt using cyclophosphamide plus G-CSF. Consolidation: Cycles 6-8 At day +90, after autologous stem cell transplant patients will receive consolidation treatment with 1 additional cycle of belantamab mafodotin + 2 additional cycles of VRd following the same scheme as in the induction: - Belantamab mafodotin will be administered at the dose of 2.5 mg/kg/every 8 weeks on day 1, intravenously. - Bortezomib will be given subcutaneously, at 1.3 mg/m2, on days: 1, 4, 8 and 11 of every 28-day cycle. - Lenalidomide will be given as an oral drug, in the dose of 25 mg/day on days 1-21. - Dexamethasone will be given as an oral drug, at the dose of 20 mg on days: 1, 2, 4, 5, 8, 9, 11 and 12 of every 28-day cycle. Maintenance: After completion of the consolidation treatment, all the responding patients will receive maintenance treatment with Lenalidomide (10 mg/day) + belantamab mafodotin (2.5 mg/kg/every 8 weeks, intravenously). Lenalidomide will be administered continuously until disease progression, patient withdrawal, unacceptable toxicity loss to follow up, end of study or death. Belantamab mafodotin will be administered for 2 years until disease progression, patient withdrawal, loss to follow up, unacceptable toxicity, end of study or death. The trial has the following objectives: Objectives: Primary objective ● To evaluate the safety and tolerability of the combination of belantamab mafodotin + VRd in newly diagnosed transplant eligible multiple myeloma patients. Secondary objectives ● To assess the efficacy of belantamab mafodotin in combination with VRd in terms of response rate focusing on complete response and MRD. • Efficiency of hematopoietic stem cell collection after 2 induction cycles of treatment of belantamab mafodotin + 4 induction cycles of treatment of VRd.

    Phase

    2

    Span

    226 weeks

    Sponsor

    PETHEMA Foundation

    Santiago de Compostela, Galicia

    Recruiting

  • A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia

    This study comprises 2 parts: Dose Optimization part (Part 1) followed by a Dose Expansion part (Part 2). The study is designed to evaluate multiple doses and dosing intervals of mRNA-3705. In both parts, after confirmation of eligibility, participants will enter an Observation Period (48 to 72 hours pre-dose) in Part 1 and 24 hours before dose 1 in Part 2), followed by the Treatment Period. Participants who complete the Treatment Period, including the End of Treatment (EOT) Visit, are offered participation in the mRNA-3705 extension study. If the participant chooses to participate and meets eligibility criteria, they will be enrolled in the extension study; otherwise, they will transition to the follow-up part of the study (approximately 2-year follow-up in Part 1 and 6-months follow-up in Part 2).

    Phase

    1/2

    Span

    365 weeks

    Sponsor

    ModernaTX, Inc.

    Santiago de Compostela

    Recruiting

  • Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

    This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.

    Phase

    3

    Span

    432 weeks

    Sponsor

    AstraZeneca

    Santiago de Compostela

    Recruiting

  • Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer

    Phase II, randomized, open label, multicenterstudy. Randomization on a 1:1 ratio, stratification performed according to: BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).

    Phase

    2

    Span

    422 weeks

    Sponsor

    ARCAGY/ GINECO GROUP

    Santiago de Compostela

    Recruiting

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