“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”
“An Independent Data and Safety Monitoring Board (DSMB) unanimously recommended that the Phase 1/2 clinical trial evaluating VBI Vaccines’ VBI-1901 continue to enroll patients with recurrent glioblastoma (GBM) in a second study arm.
“The positive review recommended the study continue without modification, after scanning through all safety data from the first group of patients, who received the lowest VBI-1901 dose. Enrollment now has commenced for the second, intermediate-dose study arm.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”
“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.
“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”
“Historically, patients with melanoma who develop brain metastases have been excluded from clinical trials, according to Harriet Kluger, MD.
“As of late, an increasing number of patients in this subgroup are being included now on studies, particularly those who have received prior treatment. Yet this is still not enough, says Kluger, as brain metastases is no longer the dismal prognosis that it once was.”
“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.
“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.
“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”
“Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. today announced an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment.
“Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca™(rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).”