Prostate cancer Cancer Malignant neoplasm of the prostate
Conditions
Interventions
This is a non-randomized, open-label, single sequence, crossover study. All subjects will receive both study drugs. There are 2 study arms (with approximately 15 subjects each) that will be executed s
Sponsors
Roche (United States) (Genentech, Inc)
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Age =18 years 2. Eastern Collaborative Oncology Group performance status of 0 or 1 at screening 3. Adequate hematologic and organ function 4. Ability to comply with the study protocol, per Investigator judgment 5. Life expectancy of at least 6 months 6. Agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Disease-Specific Inclusion Criteria: 7. Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features and has progressed during treatment of at least one hormonal therapy 8.Asymptomatic or mildly symptomatic form of prostate cancer 9. Progressive disease before initiating study treatment
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. History of malabsorption syndrome or other condition that would interfere with enteral absorption or other impairment of gastrointestinal (GI) function 2. Liver cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), or other clinically significant history of liver disease 3. Need of more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease 4. History of another malignancy within 5 years prior, unless the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of < 5% at 5 years 5. Any other diseases; cardiovascular, pulmonary, or metabolic dysfunction; physical examination finding; or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications Disease-Specific Exclusion Criteria: 6. Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate 7. Any therapy including chemotherapy or biological therapy for the treatment of CRPC In the case of hormone-sensitive prostate cancer, chemotherapy is permitted provided that it is initiated within 6 months from the time of first castration 8. Known untreated or active central nervous system (CNS) metastases 9. Use of any medications (only for the first 12 days of Arm 1) that may have the potential to affect heart rate or QTc Interval Darolutamide-Specific Exclusion Criteria: 10. Uncontrolled hypertension, recent stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure New York Heart Association (NYHA) Class III or IV 11. Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of darolutamide 12. Known hypersensitivity to darolutamide or any of its ingredients Ipatasertib-Specific Exclusion Criteria: 13. Type 1 or Type 2 diabetes mellitus requiring insulin at study entry 14. History of inflammatory bowel disease 15. Any ongoing cardiac arrhythmias (including uncontrolled atrial fibrillation) that require medical therapy 16. Uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia 17. Lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety, tolerability, and the DDI of study drugs assessed through pharmacokinetic analysis measured using: Arm 1: Plasma samples will be collected on Day 10 and Day 28 of Cycle 1, where ipatasertib and M1 (G-037720) levels will be measured on Day 10 and Day 28 of Cycle 1 and darolutamide and keto-darolutamide will be measured only on Day 28 of Cycle 1 Arm 2: Plasma samples will be collected on Day 10 and Day 28 of Cycle 1, where darolutamide and keto-darolutamide levels will be measured on Day 10 and Day 28 of Cycle1 and ipatasertib and M1 (G-037720) will be measured only on Day 28 of Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Georgia, Moldova, Ukraine
Outcome results
None listed