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NRG Oncology Approves Danbury and Norwalk Hospitals as Primary Sites for Clinical Research

In Clinical Trials by Barbara Jacoby

·         Danbury Hospital and Norwalk Hospital received approval to join NRG Oncology as primary clinical research sites. This means that patients at Danbury Hospital and Norwalk Hospital now have expanded access to the latest clinical trials for breast cancer, radiation oncology, and gynecologic cancer. ·         Through NRG Oncology clinical trials, Danbury Hospital and Norwalk Hospital patients can receive the most …

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Outsourcing in clinical trials: an EU struggle? – Data report analysis

In Clinical Trials by Barbara Jacoby

By: Claudette Hodge From: knect365.com In the collaborative environment of clinical trials, partnerships and outsourcing are essential, yet can open the door to a world of day-to-day challenges. In our recent State of the Industry Report 2019, we investigated what today’s clinical trials professionals see as the most prominent risks faced in managing relationships with third-party organisations. The survey was …

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Oncoceutics Announces FDA Acceptance of Investigational New Drug Application for Phase I Trial of ONC206

In Clinical Trials by Barbara Jacoby

Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201. The first clinical trial for ONC206 in adults …

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Quest for new cancer treatment crosses milestone

In Clinical Trials by Barbara Jacoby

Source: Rice University From: sciencedaily.com A cancer therapy has crossed a milestone in clinical trials, a major development in a decades-long quest to develop a treatment that destroys tumors without the debilitating side effects of chemotherapy, invasive surgery and radiation. A cancer therapy invented at Rice University has crossed a milestone in clinical trials, a major development in a decadeslong …

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FDA Calls for Men to be Enrolled in Breast Cancer Trials

In Clinical Trials by Barbara Jacoby

By: Michael Mezher From: raps.org The US Food and Drug Administration (FDA) on Monday issued new draft guidance encouraging drugmakers to enroll male patients in breast cancer clinical trials. While men account for less than one percent of breast cancer cases, FDA says they are more likely to be diagnosed at a later stage of disease and have historically been …

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New Strategies Are Evolving for Breast Cancer Brain Metastases

In Clinical Trials by Barbara Jacoby

By: Tony Berberabe, MPH From: onclive.com A greater focus on studying mechanisms for therapies that penetrate the blood–tumor barrier and the expansion of clinical trial eligibility criteria are opening the door for advancements that may help patients with metastatic breast cancer that has spread to the brain, according to Carey K. Anders, MD. Historically, the clinical development of treatments in …

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Another myeloma drug with same target as CAR-Ts shows successful Phase II results

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com Without providing details, GlaxoSmithKline said its trial of BCMA-targeting belantamab mafodotin was positive. The company plans to submit for regulatory approvals later this year – potentially ahead of bluebird and Celgene’s expected filing next year for the CAR-T bb2121. A Phase II study of a GlaxoSmithKline drug to treat the blood cancer multiple myeloma has …

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Alpelisib Arrives as New Targeted Option for Breast Cancer Subgroup

In Clinical Trials by Barbara Jacoby

By: Brittany Lovely From: onclive.com In May 2019, the FDA approved alpelisib (Piqray) in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)–positive, HER2-negative PIK3CA-mutated advanced or metastatic breast cancer, making it the first targeted therapy in this setting with a predictive biomarker. Overall, approximately 70% of breast cancers are classified as HR positive/HER2 …

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Many clinical trials for new cancer drugs didn’t include any data on race

In Clinical Trials by Barbara Jacoby

By: Megan Thielking From: statnews.com One-third of the clinical trials that led to new cancer drugs approved between 2008 and 2018 didn’t report on the race of trial participants — and even studies that did report on race often had far fewer black and Hispanic cancer patients than might be expected, given the makeup of the cancer patient population.That’s according …

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Lumicell Completes Enrollment of Phase C Feasibility Trial for Breast Cancer Surgical Guidance Solution

In Clinical Trials by Barbara Jacoby

From: biospace.com Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced that it has completed enrollment in its Phase C feasibility clinical trial of the Lumicell Imaging System for breast cancer. With results from the Phase C feasibility trial expected in late 2019, Lumicell expects to begin the pivotal trial by the end of 2019 before applying …