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An open-label phase IB study to evaluate GSK3052230 in combination with paclitaxel and carboplatin, or docetaxel, in FGFR1-amplified non-small cell lung cancer

Affiliations.

• 1 Washington University School of Medicine, St. Louis, MO, USA.
• 2 St. Petersburg City Oncology Dispensary, St. Petersburg, Russian Federation.
• 3 Servicio de Oncologia, Hospital General Universitario Vall d'Hebron, Barcelona, Spain.
• 4 Hospital Infanta Cristina, Badajoz, Spain.
• 5 Arkhangelsk Regional Oncology Dispensary, Arkhangelsk, Russian Federation.
• 6 Fundación Jiménez Díaz, Madrid, Spain.
• 7 University of California, Davis Medical Center, Sacramento, CA, USA.
• 8 Memorial Sloan Kettering Cancer Center, New York, NY, USA.
• 9 Department of Oncology Rigshospitalet, Copenhagen, Denmark.
• 10 First Pavlov State Medical University, St. Petersburg, Russian Federation.
• 11 Hospital Universitario Virgen de la Victoria, Málaga, Spain.
• 12 Regional Clinical Oncology Dispensary, Ryazan, Russian Federation.
• 13 GlaxoSmithKline, Inc., Collegeville, PA, USA.
• 14 GlaxoSmithKline, Inc., Collegeville, PA, USA. Electronic address: [email protected].
• 15 Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. Electronic address: [email protected].
• PMID: 31446228
• DOI: 10.1016/j.lungcan.2019.08.011

Objectives: GSK3052230 (FP-1039) is a soluble fusion protein that acts as ligand trap sequestering fibroblast growth factors (FGFs) involved in tumor growth and angiogenesis, while sparing the hormonal FGFs. Because of this selectivity, the molecule is predicted to avoid toxicities associated with small molecule inhibitors of FGFR, including hyperphosphatemia and retinal, nail, and skin toxicities. Herein we report the results of a phase 1b study where GSK3052330 was administered with standard of care chemotherapy in FGFR1-amplified squamous non-small cell lung cancer (sqNSCLC) patients.

Methods and methods: Eligible patients with stage IV or recurrent metastatic sqNSCLC harboring FGFR1 gene amplification received escalating doses of GSK3052230 in combination with paclitaxel and carboplatin at the starting doses 200 mg/m 2 and AUC of 6, respectively, in the first line setting (Arm A) or docetaxel 75 mg/m 2 in second line (Arm B). The primary endpoints of the study were safety and tolerability, to identify a maximum tolerated dose (MTD), and to assess overall response rate (ORR) based on investigator assessment.

Results: Twenty-nine patients were enrolled into the study, including 20 patients on Arm A and 9 patients on Arm B. There were no dose limiting toxicities in either Arm and the MTD was not reached. The most common adverse events (AEs) were compatible with the chemotherapy backbone used in each Arm, including neutropenia, alopecia, nausea, arthralgia, asthenia, diarrhea and peripheral neuropathy. The overall response rate and median progression-free survival were 47% and 5.5 months, respectively, for Arm A and 0% and 4.6 months, respectively, for Arm B.

Conclusion: GSK3052230 is a novel FGFR pathway inhibitor, which is well tolerated in combination with chemotherapy. Importantly, AEs associated with small molecule inhibitors of FGFR were not observed, as predicted by the unique mechanism of action of this drug.

Keywords: Combination therapy; FGFR1; Ligand trap; Phase 1; Squamous non-small cell lung cancer.

Copyright © 2019 Elsevier B.V. All rights reserved.

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The Clinical Research Center (CRC) facilitates safe and controlled inpatient and outpatient studies for medical research at URMC. The CRC provides the environment, infrastructure, and staff expertise to URMC faculty, staff, and medical students conducting research studies with human subjects. The CRC has a history of support for successful neurology, gene therapy, neuromuscular disease, natural history, and disease progression studies—and can accommodate a wide variety of medical research.

Please visit Apply for CRC Support  to begin. The CRC is currently located in the Saunders Research Building in Suite 1.302.

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Precision Medicine for Parkinson’s Disease Is Focus of New Yale Center

Clemens Scherzer, MD , is on a mission to revolutionize the treatment of Parkinson’s disease through the use of genomics and artificial intelligence (AI) to create tailored therapeutics. In January, Scherzer joined Yale School of Medicine (YSM) and stepped into his new role as director of the Stephen & Denise Adams Center for Parkinson’s Disease Research. The center’s unique approach to developing the future of precision medicine for Parkinson’s disease is the first of its kind, he says.

“Right now, we wait for Parkinson’s disease to progress and cause debilitating symptoms that drive the patient to the clinic, where we scramble to catch up with treating them,” says Scherzer. “Through our new center, we want to learn to catch the disease early, be able to predict what the future will hold for each patient, and then intervene to prevent debilitating progression from ever occurring.”

Researchers will identify targets for new Parkinson’s disease medications

Scherzer envisions a future in which a person with Parkinson’s disease can walk into a clinic and provide a few drops of blood that a computer program can analyze to identify the patient’s genome and biomolecules. Clinicians would be able to use this information in addition to the patient’s electronic health data to determine the exact disease driver and to recommend precision therapeutics based on tailored biomarkers.

“Our work is similar to how a search engine targets advertisements to a user based on massive search histories,” he explains. “The goal is to precisely match the right drug to the right person at the right time, based on a search of the entire disease biology.”

To make this vision a reality, Scherzer and his team are building a multi-modal human atlas of Parkinson’s disease by cataloging molecular and clinical data from thousands of patients. Scherzer began this work while at Harvard Medical School, where he was professor of neurology, director of the American Parkinson’s Disease Association (APDA) Center for Advanced Parkinson Research, and director of the Precision Neurology Program at Brigham and Women’s Hospital. He will be advancing these efforts at YSM.

So far, Scherzer’s team has already sequenced the RNA programs of one million human brain cells spanning the entirety of disease progression—from healthy brains, to those in the earliest stages of Parkinson’s, to those in the most advanced manifestations of the disease.

Other ongoing work that also will be expanding at the Yale center includes the Yale Harvard Biomarkers Study, which involves mapping the genetic variants that control the course of Parkinson’s and using multi-omics technology to catalog molecules in patients’ biofluids. The biobank already has hundreds of thousands patient samples of DNA, RNA, plasma, and more—stored at the Yale Adams Center and with collaborators at Mass General Brigham—that he and his program have extensively characterized over several years as patients’ disease advanced. “This is a treasure trove for discovery of genes, therapeutics, and biomarkers,” says Scherzer.

The goal is to precisely match the right drug to the right person at the right time, based on a search of the entire disease biology. Clemens Scherzer, MD

For example, approximately 10% of patients with sporadic Parkinson’s disease [in which the patient has no clear familial history] have a mutation in a gene known as GBA . Researchers have discovered four different types of genetic variants of this gene that regulate the speed of progression of the disease. Those with the most severe mutation suffer a very rapid progression of their condition. After identifying this disease driver, a research team Scherzer led at Harvard collaborated with a pharmaceutical company to target this gene with precision medicine. The collaboration contributed to the first Phase 2 clinical trial focused on a genetic form of Parkinson’s and provided a tool kit for precision trials targeting GBA .

Scherzer hopes to use the power of genomics and AI to turn data into medicine. The center is using computational neuroscience and machine learning to accelerate research. “With powerful sequencing and computational technologies, we can look at 30,000 genes in a million brain cells in parallel and let biology tell us what is truly important to work on.”

Paving the way to precision medicine for Parkinson’s disease

Now, Scherzer’s ambitions include identifying other disease drivers and learning how to target them. “We’re on a quest to decode the RNA software of brain cells and figure out how to develop tailored drugs that correct any glitches,” he says. “Then, our goal is to launch early-stage clinical trials based on our newly identified drug targets.”

To fast-track drug development, the researchers are utilizing electronic patient data from entire populations and from their Yale Harvard Biomarkers Study to find old drugs that could be repurposed for Parkinson’s patients. In collaboration with the University of Bergen in Norway, Clemens’ team is using computer models to compare health outcomes recorded over a decade in thousands of individuals with Parkinson’s disease on a medication compared to millions of individuals with Parkinson’s not on the medication. “We are searching for old drugs that can be taught new tricks to help patients with Parkinson’s disease,” says Scherzer.

This search is identifying drugs for possible repurposing, including medications commonly used for asthma known as beta2 agonists. In the lab, the researchers observed that in neurons grown in a dish, the asthma drugs lowered the activity of the alpha-synuclein gene and improved the cells’ health. “This was intriguing because the brains of Parkinson’s patients are full of Lewy bodies, which are piles of alpha-synuclein,” says Scherzer. “Dialing down alpha-synuclein levels would be ideal to correct this disease driver.”

Several beta2 agonists are currently in clinical trials. Scherzer and colleagues hope that their repurposing platform will spur even more clinical trials.

A central goal of the Yale center is to develop new and more effective Parkinson’s disease medications that slow or block disease progression and prevent disabling symptoms from ever occurring. “We already have dopamine replacement medicines that treat patients very well for several years, but then debilitating complications develop,” says Scherzer. “If we can identify drugs that extend this therapeutic window for 10 years or more, many patients will never suffer these complications.”

His longer-term vision is to one day build a precision neurology clinic where those living with Parkinson’s disease receive personalized treatments. “We are going to change patients’ lives,” says Scherzer.

Featured in this article

• Clemens Scherzer, MD Director of the Stephen & Denise Adams Center for Parkinson’s Disease Research

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CDRH Issues 2024 Safety and Innovation Reports

Reports highlight CDRH actions to advance medical device safety and innovation and build on these efforts this year.

FOR IMMEDIATE RELEASE April 17, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers.

As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices.

Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program , the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009.

In parallel, we took significant actions to improve device safety and enhanced our ability to identify and address new safety signals. We achieved an ambitious set of goals outlined in our 2018 Medical Device Safety Action Plan to help ensure patient safety throughout the Total Product Life Cycle (TPLC) of a medical device. We made improvements and updates to our medical device reporting programs, including updating the Manufacturer and User Facility Device Experience (MAUDE) database, vastly improved our recalls program, and took steps to ensure the timely communication and resolution of new or known safety issues.

And throughout, we partnered with patients and incorporated their voices into our work, including establishing our Patient Science and Engagement Program, because at the end of the day, improving the health and the quality of life of people is at the core of our public health mission.

We are proud of the progress we've made to advance innovation and improve the safety of medical devices, and we continue to build on these efforts, as resources and additional capabilities permit. One of the challenges we face, though, is the sheer volume of products and producers. Today there about 257,000 different types of medical devices on the U.S. market, made by approximately 22,000 manufacturing facilities worldwide, and CDRH authorizes roughly a dozen new or modified devices every business day. Despite that, the number of new or increased known safety issues involve only a small fraction of technologies and many can be addressed without any changes to the device itself. However, the impact to people can be significant, which is why we need to continuously take steps to advance both safety and innovation.

This year, we will take additional actions to help further ensure innovative, high-quality, safe, and effective devices are developed and marketed to U.S. patients. As further detailed in the 2024 Innovation Report, three actions we plan to take this year include: reimagining our premarket review program, expanding our footprint in geographical innovation centers, and launching a new home as a health care hub to extend first-class care into the home. Additionally, as detailed in the 2024 Safety Report, three actions we plan to take this year include: expanding a program to assist companies improve their device quality efforts, strengthening active surveillance, and enhancing the medical device recall process.

Through these new actions and the work detailed in the 2024 Safety and Innovation reports, CDRH remains committed to furthering our mission to protect and promote the public health and ensure our organization is well-positioned to meet the needs of all people and changes in the medical device ecosystem.

Additional Resources:

• 2024 Innovation Report
• 2024 Safety Report
• 2018 Medical Device Safety Action Plan

• Pro pacienty
• Pro zadavatele klinických studií
• Systém řízení kvality

″ Jsme přesvědčeni, že přístup a kvalitní práce koordinátorů a lékařských center sítě Clinical Research Center šetří sponzorům a zadavatelům studií jejich vlastní zdroje. ″

Proč děláme to, co děláme.

Věříte, že AKTIVNÍM zapojením koordinátora klinických studií lze zvýšit efektivitu lékařského týmu i kvalitu a včasnost relevantních studijních dat, a také podpořit úspěšný nábor pacientů?

Chcete-li spolupracovat s lékařskými centry využívající služeb kvalifikovaných koordinátorů klinických studií, potom je tým Clinical Research Center s.r.o. vhodnou volbou.

Jsme přesvědčeni, že přístup a kvalitní práce koordinátorů a lékařských center sítě Clinical Research Center šetří sponzorům a zadavatelům studií jejich vlastní zdroje. Současně zvyšujeme informovanost a komfort pacientů.

JAK toho dosahujeme?

Clinical Research Center jako síť center klinických studií vybírá, sdružuje a dále školí zkušené lékaře různých specializací za účelem provádění klinických studií ve fázi II-IV. Zároveň rozvíjíme tým profesionálních studijních koordinátorů v několika regionech ČR. Náš tým – lékař & koordinátor – spolupracuje dle zásad správné klinické praxe, české a evropské legislativy. Znalosti a aktivní účast kvalifikovaných koordinátorů na výkonu studie je klíčem k úspěšnému naplnění požadavků sponzorů.

Naši lékaři, nezatíženi administrativou, věnují více času náboru vhodných pacientů a bezpečnosti studie. Po vzájemné dohodě podporuje CRC tento nábor různými formami kampaně, vždy však v souladu s nařízením sponzora a SÚKL.

Dodržování protokolu studie všemi členy studijního týmu je hlavní zásadou při vykonávání všech činností v procesu klinických studií. Koordinátoři i lékaři mají GCP i IATA certifikát. Klademe důraz na kvalitu a věrohodnost získaných dat, jejich zpracování a archivaci. Máme dlouhodobé zkušenosti s různými typy klinických studií. Náš tým umí zareagovat na změny protokolu i nouzové situace, dbá na včasné předání pacientských dat skrze CRF a jiné systémy dané studie a pomáhá i při včasném reportování SAE.

Jsme členem SCRS (Society for Clinical Research Sites), účastníme se mezinárodních kongresů a neustále se vzděláváme. Inovujeme a zlepšujeme naše procesy. Kde to jde, tam naše činnosti standardizujeme, automatizujeme a digitalizujeme. Rozvíjíme firemní systém řízení, který pravidelně necháváme ověřovat a certifikovat dle normy ISO 9001:2015.

CO děláme, CO nabízíme?

• Těžištěm našich služeb je administrativa, koordinace klinických studií a podpora lékařských center .
• Rozvíjíme a spravujeme síť lékařů CRC – Podívejte se jak vnímají naše služby lékaři
• Centralizovanou feasibilitou a zapojením našich lékařských center zkracujeme celkový čas tohoto procesu .
• Díky dostupnosti vlastních standardizovaných smluv a dokumentů potřebných pro výběr centra či podání na EK výrazně zjednodušujeme administrativní úkony a zkracujeme související lhůty před startem studie .
• Podporujeme lékařská centra i sponzora při tvorbě a kontrole rozpočtu studie .
• Disponuje kalibrovanými přístroji a měřidly , která zapůjčujeme lékařům sítě CRC.
• Pomáháme zvyšovat nábor pacientů zapojením referujících lékařů a různými formami kampaně v souladu s nařízením sponzora a SÚKL.
• Školíme studijní tým .
• Pomáháme při zajištění externího (domácího) odběru biologických vzorků .
• Dostupnost a znalosti našich koordinátorů zvyšují efektivnost komunikace mezi monitorem a centrem .
• Hodnotíme naše centra i interní procesy a související KPIs , provádíme analýzu relevantních dat.
• Náš tým podporuje rozvoj vlastních i externích IT řešení pro výkon studií .

V souladu se schváleným protokolem studie a s místními zákony náš tým CRC Home Care zajišťuje také domácí pacientské návštěvy.

Naši lékaři – naše specializace

V České republice v současnosti aktivně spolupracujeme s více než 80 osvědčenými lékařskými centry . Celkový počet lékařských center v síti Clinical Research Center s.r.o. již přesáhl hranici 10, a to v následujících specializacích:

Alergologie a imunologie

Dermatologie

Diabetologie

• Gastroenterologie

Gynekologie

• Interní medicína

Kardiologie

Léčba bolesti

• Obezitologie

Oční lékařství

Plicní lékařství

Revmatologie

• Všeobecná medicína

Gastroentologie

Interní lékařství

Obesitologie

Praktický lékař

Pokud chcete získat více informací, máte zájem o spolupráci či chcete přímo zaslat Feasibility dotazník , prosím kontaktujte nás .

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