First Patients Dosed in Phase 2b Trial Testing Oral Docetaxel Treatment for Advanced Prostate Cancer

A Phase 2b clinical trial evaluating ModraDoc006/r, Modra Pharmaceutical’s investigational oral treatment for metastatic castration-resistant prostate cancer, has started dosing patients, the company announced.

ModraDoc006/r is a tablet formulation of the chemotherapy docetaxel. Doctors administer it with ritonavir, which increases the amount of docetaxel absorbed by the body.

Being an oral formulation, ModraDoc006/r allows patients to receive chemotherapy at home, and scientists believe it poses a lower risk for toxicities (namely low counts of immune cells and damage to the nerves), and an increased effectiveness.

“Intravenously administered chemotherapy is widely used, but nevertheless always involves a significant time investment for patients in regard to travel to and from the clinic and receiving the treatment itself, as well as the considerable burden of dealing with its side effects,” Ulka Vaishampayan, MD, said in a press release. Vaishampayan is principal investigator of the trial and a professor of oncology at the Barbara Ann Karmanos Cancer Institute, Detroit, Michigan.

“To that end, ModraDoc006/r has the potential to become an exciting new oral option for prostate cancer which retains or improves on the therapeutic characteristics of docetaxel and easily incorporates chemotherapy within the lives of cancer patients,” Vaishampayan said.

The trial (NCT04028388) will be conducted at approximately 40 clinical centers in the United States and Europe, and is currently recruiting participants. More information of enrollment can be found here.

Participants — a total of 100 men with metastatic castration-resistant prostate cancer — will be randomized to first-line treatment with the oral tablet ModraDoc006/r, or injection of docetaxel. The oral therapy will be taken once a week, and intravenous docetaxel once every three weeks. All patients also will receive oral prednisone (a corticosteroid) twice daily.

The trial’s main objective is to assess the proportion of patients achieving a response to treatment, but researchers also will determine the treatment’s safety, time to disease worsening or death, duration of responses, and quality of life as secondary measures.

Preliminary data from the trial is expected during the first half of 2021.

“Prostate cancer is one of the most commonly diagnosed malignancies in men in the Western world, with docetaxel typically administered as the first line of chemotherapy treatment in the metastatic setting. Improving outcomes for these patients by reducing key toxicities and enhancing efficacy associated with the use of chemotherapy would meet a significant need. Our objective is therefore to demonstrate clinical benefit over current standard of care while also making a positive impact on patients’ lives,” said Colin Freund, CEO of Modra.

“Based on our existing pre-clinical and clinical data, we believe ModraDoc006/r has the potential to favorably impact treatment outcomes and raise the quality of life for prostate cancer patients,” said Edwin de Wit, MD, chief development officer of Modra. “This comparative Phase IIb trial will enable us to evaluate the benefits of oral ModraDoc006/r versus standard of care intravenous docetaxel.”

ModraDoc006/r also is under clinical testing in a Phase 2 study (NCT03890744) for patients with advanced breast cancer. That trial also is recruiting, and more information is available here.