This phase 2b trial will evaluate ModraDoc006 (MOD) in patients with metastatic castration-resistant prostate cancer (mCRPC). The main outcomes will be the objective response rate (ORR). This trial is recruiting at a number of locations in the US.
Metastatic castration-resistant prostate cancer (mCRPC) is cancer that has spread to other organs and no longer responds to hormonal therapy (HT). HT works by reducing the level of testosterone (TTT) because TTT can drive PC growth. Patients with mCRPC are treated with chemotherapy (CT).Docetaxel (Taxotere) is a CT drug used to treat mCRPC. It is a taxane. Docetaxel is associated with toxic side effects. ModraDoc006 (MOD) is a new oral formulation of docetaxel.
This trial will evaluate MOD in patients with mCRPC. The main outcomes will be ORR.
Who are they looking for?
This trial will recruit 100 patients with mCRPC. Participants must have adequate liver and kidney function. Patients must have no existing toxicity to treatment. Patients must be willing to take oral medication and undergo computed tomography scans.
Patients cannot take part in the trial if they been previously treated with taxanes. Patients cannot take part in the trial if they have other cancers, acute or chronic infections, and uncontrolled hypertension. Patients cannot be taking drugs that target certain transporter proteins. Other exclusion criteria are cardiovascular disease, recent major surgery, and bowel obstruction.
How will it work
Patients will be randomly assigned to either MOD or docetaxel treatment. Docetaxel will be administered once every 3 weeks via intravenous infusion. MOD will be taken orally twice daily. A drug called ritonavir (an antiviral drug used in the treatment of HIV infection) will also be taken with MOD. All patients will take oral prednisone (a steroid drug) twice daily. Treatment will continue until disease progression or the patient cannot tolerate the side effects.