Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, announced dosing of the first patient in a clinical trial to evaluate the administration of Rolontis on the same day as chemotherapy. The trial will evaluate the duration of severe neutropenia when administered at three different time points on the same day following standard chemotherapy in patients with early stage breast cancer. Rolontis is an investigational drug not approved by the US Food and Drug Administration (FDA) and the BLA is currently under active review by the agency for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24, 2020.
“This study exemplifies our commitment to unlocking the full potential of Rolontis, the first novel biologic positioned to enter the G-CSF market since 2001. A same day dosing option would be a unique and meaningful addition to the G-CSF category,” said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. “We will continue to follow the science and explore ways to add value to patients and health care providers. The initiation of this study, despite the pandemic, highlights investigator’s interest and our team’s dedication.”
“This clinical trial will provide information on the pharmacodynamic effects of Rolontis given the same day as chemotherapy and it could provide a scientific basis to re-examine the way neutropenia is managed in patients who receive myelosuppressive chemotherapy,” said Francois Lebel, M.D., chief medical fficer of Spectrum Pharmaceuticals. “Same day dosing could possibly enhance compliance, lead to better patient outcomes and minimize patient’s burden in terms of simplified logistical issues associated with the administration of currently available growth factors that specify next day dosing following chemotherapy.”
This clinical trial will compare the effect of Rolontis on the duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following docetaxel and cyclophosphamide. Approximately 45 patients will be enrolled in this phase 1, open label, trial with 1:1:1 randomization to three dosing time schedule arms. Each treatment cycle will be 21 days and a total of four cycles will be evaluated. On day 1 of cycle 1, patients will receive chemotherapy followed by administration of Rolontis at 30 minutes, 3 hours or 5 hours. During cycles 2 – 4, patients will receive Rolontis 24 hours after chemotherapy. The primary endpoint is duration of Grade 4 neutropenia in cycle 1. A number of secondary endpoints in cycle 1 will be evaluated including incidence of neutropenia, time to recovery of severe neutropenia, incidence of grade 3 febrile neutropenia, pharmacokinetics, and number of patients with adverse events as a measure of safety. Additional information about this clinical trial can be found at www.clinicaltrials.gov using the identifier NCT04187898.