MedPath

Clinical Trial News

FDA Approves Sandoz's Erelzi as First Enbrel Biosimilar in US

  • Sandoz's Erelzi (etanercept-szzs) has received FDA approval as the first biosimilar to Amgen's Enbrel, covering all indications of the reference product for inflammatory diseases.
  • The approval marks a significant milestone in the US biosimilars landscape, potentially impacting the $5 billion annual US market for Enbrel.
  • The biosimilar approval aligns with healthcare cost reduction goals, with IMS Health projecting potential savings of up to $110 billion by 2020 across the US and five largest EU countries.

Comprehensive Guide: Clinical Trial Regulatory Pathways Across 10 Asia-Pacific Nations

  • Australia's unique Human Research Ethics Committees (HRECs) system provides trial oversight, with the Clinical Trial Notification (CTN) pathway being the preferred route for conducting clinical trials.
  • India requires Drug Controller General approval and local ethics committee clearance, with the new Online Clinical Trial Application and Monitoring System (OCTAMS) streamlining submissions.
  • Singapore, Malaysia, and South Korea have established parallel submission processes for regulatory and ethics approvals, with specific requirements for local and imported investigational products.

Study Protocol for a Randomized Controlled, Non-Inferiority Trial on Blended Depression Treatment in Europe

The E-COMPARED project aims to evaluate the clinical and cost-effectiveness of blended depression treatment, combining Internet-based and face-to-face cognitive behavioral therapy (CBT), compared to treatment-as-usual (TAU) across eight European countries. This pragmatic, multinational trial seeks to improve access to cost-effective depression treatments, addressing the significant societal and economic burden of depression.

Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet

NCT02449447CompletedNot Applicable
Linkoeping University
Posted 2/1/2015

European Comparative Effectiveness Research on Internet-based Depression Treatment

NCT02542891CompletedNot Applicable
Institut National de la Santé Et de la Recherche Médicale, France
Posted 9/1/2015

e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial

NCT02361684CompletedNot Applicable
Universitat Jaume I
Posted 2/1/2015

European Comparative Effectiveness Research on Internet-based Depression Treatment in Poland

NCT02389660CompletedNot Applicable
University of Social Sciences and Humanities, Warsaw
Posted 6/1/2015

E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial

NCT02410616CompletedNot Applicable
University of Bern
Posted 3/1/2015

Precision Oncology Medicine: The Clinical Relevance of Patient Specific Biomarkers Used to Optimize Cancer Treatment

Precision medicine in oncology leverages patient-specific clinical features and genomic-based diagnostics to optimize cancer treatment. This approach utilizes companion diagnostics for specific drug-target pairs, germline mutations affecting drug response, and multigene expression-based assays to guide treatment decisions. The article highlights the importance of biomarkers in predicting drug response, toxicity, and the shift towards a comprehensive, multi-gene approach in cancer therapy.

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

NCT01042379RecruitingPhase 2
QuantumLeap Healthcare Collaborative
Posted 3/1/2010

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

NCT02091141CompletedPhase 2
Genentech, Inc.
Posted 4/14/2014

Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies

NCT01306045CompletedPhase 2
National Cancer Institute (NCI)
Posted 2/8/2011

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

NCT02187783CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/25/2014

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

NCT02034110CompletedPhase 2
Novartis Pharmaceuticals
Posted 3/12/2014

BKM120 for Patients With PI3K-activated Tumors

NCT01833169CompletedPhase 2
Novartis Pharmaceuticals
Posted 3/29/2013

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

NCT02693535RecruitingPhase 2
American Society of Clinical Oncology
Posted 3/14/2016

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

NCT02299999Active, Not RecruitingPhase 2
UNICANCER
Posted 4/7/2014

LDE225 for Patients With PTCH1 or SMO Mutated Tumors

NCT02002689TerminatedPhase 2
Novartis Pharmaceuticals
Posted 2/1/2014

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

NCT02075840CompletedPhase 3
Hoffmann-La Roche
Posted 8/19/2014

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

NCT02154490Completed
SWOG Cancer Research Network
Posted 7/8/2014

A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer

NCT01771458Unknown StatusPhase 2
Institut Curie
Posted 10/1/2012

MEK162 for Patients With RAS/RAF/MEK Activated Tumors

NCT01885195CompletedPhase 2
Pfizer
Posted 10/10/2013

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

NCT02664935Active, Not RecruitingPhase 2
University of Birmingham
Posted 5/1/2015

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

NCT02117167CompletedPhase 2
UNICANCER
Posted 4/23/2014

CREATE: Cross-tumoral Phase 2 With Crizotinib

NCT01524926CompletedPhase 2
European Organisation for Research and Treatment of Cancer - EORTC
Posted 9/1/2012

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

NCT02465060Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 8/17/2015

BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

NCT01248247CompletedPhase 2
M.D. Anderson Cancer Center
Posted 6/2/2011

Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

NCT02201992RecruitingPhase 3
ECOG-ACRIN Cancer Research Group
Posted 3/23/2015

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

NCT02160041TerminatedPhase 2
Novartis Pharmaceuticals
Posted 7/24/2014

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib

NCT01831726CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/1/2013

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

NCT02194738Active, Not RecruitingNot Applicable
National Cancer Institute (NCI)
Posted 9/26/2014

Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

NCT02193282Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 2/11/2015

Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

NCT02186821TerminatedPhase 2
Novartis Pharmaceuticals
Posted 9/17/2014

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978CompletedPhase 2
Hoffmann-La Roche
Posted 4/12/2012

LGX818 for Patients With BRAFV600 Mutated Tumors

NCT01981187TerminatedPhase 2
Pfizer
Posted 1/14/2014

MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations

NCT01827384CompletedPhase 2
National Cancer Institute (NCI)
Posted 1/7/2014

Early Physical Therapy Safe and Tolerable for Youth Concussion Recovery

  • A retrospective study suggests early physical therapy (PT) intervention (0-20 days post-injury) for youth with concussions is safe and tolerable.
  • The study found no significant differences in symptom change, unplanned healthcare visits, or therapy duration across early, middle, and late PT intervention groups.
  • Findings support the feasibility of incorporating multimodal, impairment-based PT within three weeks post-concussion to facilitate prompt recovery.
  • Further prospective studies are needed to validate these findings and identify the optimal timing for PT services in concussion management.

Risk-Based Monitoring Revolutionizes Clinical Trial Quality Management

  • TransCelerate Biopharma's Risk-Based Monitoring Initiative is transforming clinical trial oversight by shifting from traditional on-site monitoring to a more targeted, data-driven approach.
  • The initiative provides comprehensive tools and frameworks for implementing RBM, including updated risk assessment tools and guidelines for source data verification and review.
  • Implementation of risk-based monitoring strategies aims to enhance patient safety, improve data quality, and potentially reduce costs across clinical trials.

New Research Reveals Key Strategies for Identifying and Engaging Pharmaceutical Industry's Rising Stars

  • Key opinion leaders emphasize that identifying rising stars should focus on innovative research and novel approaches rather than just publication counts or academic credentials.
  • Cultural and geographical factors significantly influence rising star development, with emerging markets like Brazil, India, and Turkey showing particularly strong potential for new talent.
  • Pharmaceutical companies are advised to implement specific strategies including dedicated advisory board positions and targeted support programs for emerging markets and underrepresented groups.

EMA Launches PRIME Initiative to Accelerate Access to Breakthrough Medicines in Europe

• The European Medicines Agency has introduced PRIME (PRIority MEdicines), a new fast-track program designed to match the FDA's Breakthrough Therapy Designation and expedite access to promising new drugs.
• The initiative offers enhanced scientific support and early dialogue with developers, aiming to reduce both development and regulatory approval times for medicines addressing unmet medical needs.
• PRIME will run parallel with ADAPT SMART program, incorporating early engagement with health technology assessment bodies to address pricing and reimbursement challenges in European markets.

Lenalidomide Approved as First-Line Therapy for Multiple Myeloma

  • The FDA approved lenalidomide (Revlimid) in combination with low-dose dexamethasone as a first-line treatment for multiple myeloma in 2015.
  • The approval was based on the Phase 3 FIRST trial, which demonstrated improved progression-free and overall survival compared to melphalan, prednisone, and thalidomide (MPT).
  • Lenalidomide is an oral immunomodulatory agent that inhibits proliferation and induces apoptosis of hematopoietic tumor cells, enhancing T-cell and NK-cell immunity.
  • Common adverse reactions associated with lenalidomide plus dexamethasone include diarrhea, back pain, asthenia, and rash, with warnings for hematologic toxicity and thromboembolism.

VIPER Trial: Evaluating Surgical Strategies for Pseudophakic Retinal Detachment

  • The VIPER trial investigates the efficacy of adding an encircling band to 20G vitrectomy for pseudophakic retinal detachment (PRD).
  • The study also explores whether 23/25G vitrectomy is non-inferior to 20G vitrectomy without an encircling band for PRD treatment.
  • The primary endpoint is the absence of any need for additional retina re-attaching surgical procedures during the follow-up period.
  • The trial uses a multi-center, randomized design to compare different surgical approaches for managing PRD.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.