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Drug could alleviate side effects of chemo for breast cancer patients

In Clinical Trials by Barbara Jacoby

By: Mandy Erickson From: stanford.edu Stanford researchers have found a way to predict who will suffer heart problems from a common breast-cancer drug, as well as identified an FDA-approved medication that could mitigate those side effects. Researchers at the Stanford University School of Medicine have demonstrated a method of forecasting which breast cancer patients will suffer heart problems from a …

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Atossa Genetics Announces FDA Approval of Oral Endoxifen for “Expanded Access” as Post-Mastectomy Treatment for a U.S. Breast Cancer Patient

In Clinical Trials by Barbara Jacoby

Source: Atossa Genetics Inc. From: globenewswire.com Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that the FDA has issued a “Safe to Proceed” letter under their “expanded access” program permitting the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in a pre-menopausal, …

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Large Prospective Trial Validates Detection of AR-V7 Biomarker Using Epic Sciences’ Platform to Predict Treatment Outcomes for Patients with Advanced Prostate Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Epic Sciences, Inc. (Epic) today announced the publication of results from a multicenter prospective trial validating the biomarker AR-V7 (androgen receptor splice variant-7) as a predictor of resistance to anti-androgen therapy in men with metastatic castration-resistant prostate cancer (mCRPC). Data from the PROPHECY trial, published in the Journal of Clinical Oncology, demonstrate that detection of AR-V7 in circulating tumor …

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FDA suggests letting more patients with viral infections into cancer clinical trials

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com A draft guidance, not yet implemented, suggests allowing more patients with hepatitis B and C and HIV into oncology clinical trials from which they are currently excluded. On the pages of oncology clinical trials on the database ClinicalTrials.gov, the section listing the various criteria that patients must meet for enrollment commonly includes a line stating …

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Do Brain Metastases Rule Out Immunotherapy in RCC

In Clinical Trials by Barbara Jacoby

By: Jim Kling From: cancernetwork.com An interim analysis of the CheckMate 920 phase IIIb/IV trial indicates that the combination of nivolumab and ipilimumab is safe and effective in advanced renal cell carcinoma (RCC) patients with brain metastases, with encouraging antitumor activity. These findings, which were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract 4517), are …

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Lilly’s CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Global, randomized, placebo-controlled study confirms CYRAMZA, in combination with erlotinib, significantly delayed disease progression in previously untreated patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations Global regulatory submissions to be initiated this year  Second positive Phase 3 study of CYRAMZA in metastatic non-small cell lung cancer Eli Lilly and Company (NYSE: LLY) today …

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Yuhan Corp and Sorrento Therapeutics Announce Completion of Phase 1 Clinical Study of Anti-PD-L1 Antibody IMC-001

In Clinical Trials by Barbara Jacoby

Source: Sorrento Therapeutics, Inc. From: apnews.com Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced today that ImmuneOncia, a joint venture formed in September 2016, has completed the Phase 1 study of IMC-001 (also known as STI-3031), a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. This Phase 1 dose-escalation study, approved by the South Korean Ministry …

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Imaging technique finds differences between radiation-sensitive and resistant tumors

In Clinical Trials by Barbara Jacoby

Source: University of Arkansas From: sciencedaily.com Researchers have started pilot clinical studies in head and neck cancer patients to determine if Raman spectroscopy, a noninvasive imaging technique, can effectively spare some patients of the toxic side effects of ineffective radiation therapy. Researchers at the University of Arkansas, Johns Hopkins University and the University of Arkansas for Medical Sciences (UAMS) used …

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Merck’s Keytruda set to become new standard of care for renal cancer patient population after gaining edge over competitors

In Clinical Trials by Barbara Jacoby

From: globaldata.com Merck & Co Inc’s abstract presentation regarding KEYNOTE-426 trial at ASCO GU 2019 (16 February 2019) has confirmed that Keytruda, an anti-PD-1 therapy, in combination with Pfizer’s Inlyta, a tyrosine kinase inhibitor, can significantly improve clinical outcomes for renal cancer patients. Amrita Gujral, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the …

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Strategies developed to include more racial and ethnic minorities in clinical trials

In Clinical Trials by Barbara Jacoby

Source: Medical University of South Carolina From: eurekalert.org Not one size fits all, and nowhere does that show up more than in the recruitment of racial and ethnic minorities into clinical trials, says Hollings Cancer Center researcher Marvella Ford, Ph.D. This is critically important since this population has a high prevalence of certain cancers. Ford, who is associate director of …