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Clinical Trial News

Ring 20 Syndrome: Ultra-Rare Epilepsy Faces Diagnostic Challenges in Era of Modern Gene Sequencing

  • Ring Chromosome 20 Syndrome (R20), an ultra-rare form of epilepsy affecting at least 150 people worldwide, causes uncontrollable seizures and cognitive decline but remains resistant to current treatments.
  • Despite advances in genomic technology, R20 diagnoses are declining as modern gene sequencing methods cannot detect ring chromosomes, requiring traditional karyotype analysis of 100+ cells for accurate diagnosis.
  • Ring 20 Research and Support, led by Allison Watson, is launching initiatives including a natural history study, biomarker research, and global patient registry to advance understanding and awareness of the condition.

Inavolisib Combination Significantly Improves Survival in PIK3CA-Mutant Advanced Breast Cancer

Precision Medicine
  • The phase 3 INAVO120 trial demonstrated that adding inavolisib to palbociclib and fulvestrant significantly improved overall survival in patients with PIK3CA-mutant, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer.
  • This triple combination therapy represents a potential new treatment standard for this specific patient population with endocrine-resistant disease.
  • The findings highlight the importance of targeting PIK3CA mutations in hormone receptor-positive breast cancer patients who have developed resistance to endocrine therapy.

Global COVID-19 Clinical Trial Landscape: Unprecedented Research Response Marked by Coordination Challenges

  • A comprehensive analysis of 683 COVID-19 clinical trials revealed an unprecedented surge in research activity during the pandemic's first 100 days.
  • The review highlights concerns over trial coordination, with many small trials potentially duplicating efforts and straining research resources.
  • Antiviral and antimalarial drugs were the most frequently investigated treatments, with hydroxychloroquine being assessed in over 100 trials.
  • The study emphasizes the need for better coordination and data sharing to maximize the efficiency and impact of clinical research during global health crises.

Hydroxychloroquine Fails to Prevent or Treat COVID-19 in Multiple Trials

  • A University of Minnesota study found that hydroxychloroquine did not prevent COVID-19 infection in high-risk healthcare workers, with 5.9% of the hydroxychloroquine group and 7.9% of the placebo group developing the virus.
  • The NIH's ORCHID trial concluded that hydroxychloroquine provides no clinical benefit to hospitalized adults with COVID-19, with similar health status observed in both hydroxychloroquine and placebo groups after 14 days.
  • Both studies reported side effects, such as nausea and upset stomach, but no increased risk of serious cardiac complications from hydroxychloroquine compared to placebo.
  • These findings align with other trials, reinforcing that hydroxychloroquine is not an effective treatment for preventing or improving outcomes in COVID-19 patients.

Iterum Therapeutics Presents Phase 3 Sulopenem Data for UTIs at IDWeek 2020

• Iterum Therapeutics presented Phase 3 data for sulopenem in complicated and uncomplicated urinary tract infections (UTIs) at IDWeek 2020. • The SURE-1 trial demonstrated oral sulopenem's superiority to oral ciprofloxacin in treating uncomplicated UTIs caused by quinolone non-susceptible pathogens. • SURE-2 trial results for complicated UTIs involved IV sulopenem followed by oral sulopenem, compared to IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate. • Sulopenem, a novel penem anti-infective, is being developed in both oral and IV formulations to combat multi-drug resistant pathogens.

LRRC15-Targeted Antibody-Drug Conjugates Show Promise in Osteosarcoma Treatment

  • LRRC15-directed antibody-drug conjugates (ADCs) demonstrate potential as a novel therapeutic approach for osteosarcoma (OS), a bone tumor with high metastasis rates.
  • An ADC targeting LRRC15 conjugated to PNU-159682 (PNU) exhibited superior efficacy in inhibiting OS cell growth compared to an ADC with monomethyl auristatin E (MMAE).
  • In murine xenograft models, LRRC15-PNU achieved cure rates of 40-100%, highlighting its potential for clinical translation in treating OS.
  • The study suggests that inducing LRRC15 expression in low-expressing tumor cells with TGFβ could sensitize them to LRRC15 ADC treatment.

ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

NCT02565758CompletedPhase 1
AbbVie
Posted 9/18/2015

FDA Approves Remdesivir as First Official COVID-19 Treatment

  • The FDA has granted full approval to remdesivir, making it the first and only drug with federal approval for treating COVID-19.
  • Remdesivir, an antiviral medication developed by Gilead Sciences, is administered intravenously to hospitalized COVID-19 patients.
  • Clinical trials indicated that remdesivir can shorten the recovery time for hospitalized patients by an average of five days.
  • Despite conflicting results from the WHO's Solidarity trial, the FDA approval underscores remdesivir's role in COVID-19 treatment.

Comparative Analysis of PARP Inhibitors in BRCA-Mutated Ovarian Cancer Shows Similar Efficacy and Toxicity

• A network meta-analysis of PARP inhibitors (PARPi) in BRCA-mutated ovarian cancer reveals no significant differences in efficacy among various regimens used in upfront or relapsed settings. • The study assesses the cost-effectiveness of PARPi regimens using the ASCO value framework, indicating similar clinical benefits, toxicity, and net health benefit across different treatments. • Results suggest that adding bevacizumab to olaparib increases the cost per unit net health benefit compared to olaparib monotherapy in upfront treatment. • Upfront PARPi regimens demonstrate lower toxicity scores compared to those used in the relapsed setting, providing insights into treatment selection.

Clinical Trial Automation: A Game-Changing Solution for Accelerating Drug Development

  • Clinical trial automation technologies are gaining FDA support and proving essential for managing complex data, reducing human error, and streamlining the drug development process.
  • Automated systems offer five key benefits including faster trial completion, cost reduction, improved data quality, rapid analysis, and enhanced productivity throughout the clinical trial lifecycle.
  • Implementation of automation in critical areas like case report form development, metadata management, and dataset conversion can significantly accelerate time-to-market while ensuring regulatory compliance.

Comprehensive Analysis of Clinical Trials in Pancreatic Cancer Reveals Limited Advances

A detailed analysis of clinical trials for pancreatic ductal adenocarcinoma (PDAC) shows that despite significant funding and research efforts, there have been no paradigm-shifting advances in treatment over the past two decades. The majority of trials focus on chemotherapy combinations, with only a few novel therapies showing promise in phase III trials. The study highlights the urgent need for innovative treatments to improve survival rates for PDAC patients.

Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer

NCT02923921CompletedPhase 3
Eli Lilly and Company
Posted 3/1/2017

Masitinib Plus Gemcitabine in Pancreatic Cancer

NCT03766295CompletedPhase 3
AB Science
Posted 7/1/2014

Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy

NCT02871804Unknown StatusPhase 3
Wakayama Medical University
Posted 8/1/2016

Safety and Efficacy of Clopidogrel in Locally Advanced and Metastatic Pancreatic Adenocarcinoma Treated With Chemotherapy

NCT02404363TerminatedPhase 3
Assistance Publique - Hôpitaux de Paris
Posted 1/11/2016

Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

NCT01926197CompletedPhase 3
Stanford University
Posted 8/14/2013

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

NCT01954992RecruitingPhase 3
Eleison Pharmaceuticals LLC.
Posted 4/1/2014

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

NCT01964430CompletedPhase 3
Celgene
Posted 3/28/2014

Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

NCT03269994CompletedPhase 3
Memorial Sloan Kettering Cancer Center
Posted 11/21/2017

Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer

NCT02948309CompletedPhase 3
Karolinska University Hospital
Posted 6/1/2016

Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer

NCT02201381WithdrawnPhase 3
Health Clinics Limited
Posted 5/23/2022

Acelarin First Line Randomised Pancreatic Study

NCT03610100SuspendedPhase 2
The Clatterbridge Cancer Centre NHS Foundation Trust
Posted 12/1/2015

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

NCT02184195CompletedPhase 3
AstraZeneca
Posted 12/16/2014

A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer

NCT03721744RecruitingPhase 2
1Globe Health Institute LLC
Posted 10/25/2018

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

NCT03257033RecruitingPhase 3
RenovoRx
Posted 3/12/2018

Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

NCT02349412CompletedPhase 3
Alliance for Clinical Trials in Oncology
Posted 6/25/2015

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

NCT01827553CompletedPhase 3
University of Erlangen-Nürnberg Medical School
Posted 4/4/2013

Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies

NCT02340728CompletedPhase 3
Memorial Sloan Kettering Cancer Center
Posted 1/1/2015

Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

NCT02514928Unknown StatusPhase 3
Fudan University
Posted 6/1/2015

Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

NCT02172976CompletedPhase 2
Krankenhaus Nordwest
Posted 11/1/2014

Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy

NCT02853474CompletedPhase 3
Centre Oscar Lambret
Posted 10/1/2016

A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

NCT02993731CompletedPhase 3
Sumitomo Pharma America, Inc.
Posted 12/1/2016

Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy

NCT02457156CompletedPhase 3
University of Liverpool
Posted 4/23/2015

A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

NCT02539537CompletedPhase 3
UNICANCER
Posted 10/23/2015

Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

NCT03398291RecruitingPhase 3
Fudan University
Posted 7/1/2018

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

NCT03377491CompletedPhase 3
NovoCure Ltd.
Posted 2/10/2018

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

NCT01013649Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 4/5/2010

Hyperthermia European Adjuvant Trial

NCT01077427Unknown StatusPhase 3
Klinikum der Universitaet Muenchen, Grosshadern
Posted 3/1/2012

Cancer Associated Thrombosis and Isoquercetin (CATIQ)

NCT02195232CompletedPhase 2
Jeffrey Zwicker, MD
Posted 1/1/2015

Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

NCT02506842Unknown StatusPhase 3
Fudan University
Posted 6/1/2015

2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

NCT03468335CompletedPhase 3
AIO-Studien-gGmbH
Posted 3/31/2018

EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX

NCT03126435CompletedPhase 3
SynCore Biotechnology Co., Ltd.
Posted 10/16/2018

Nordic Pancreatic Cancer Trial (NorPACT) - 1

NCT02919787Active, Not RecruitingPhase 2
Oslo University Hospital
Posted 9/1/2016

High-dose Vitamin D3 in Pancreas Cancer

NCT03472833TerminatedPhase 3
Medical University of Graz
Posted 4/1/2018

Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

NCT03251365RecruitingPhase 2
Hospital General de Ciudad Real
Posted 7/27/2017

Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

NCT03504423CompletedPhase 3
Cornerstone Pharmaceuticals
Posted 11/9/2018

Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

NCT03434678CompletedPhase 3
Memorial Sloan Kettering Cancer Center
Posted 1/30/2018

Eus-guided Cryothermal Ablation in Stage III Pancreatic Adenocarcinoma

NCT03649035WithdrawnPhase 3
Istituto Clinico Humanitas
Posted 7/12/2018

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