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This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane.
Full description
This is an open label 1:1 randomized Phase 2b trial to determine the efficacy and tolerability of oral ModraDoc006/r versus i.v. docetaxel in mCRPC subjects. Cohort 1 will receive i.v. docetaxel at 75 mg/m2 every 3 weeks (Q3W). Cohort 2 will receive 30 mg ModraDoc006 in combination with 200 mg ritonavir in the morning and 20 mg ModraDoc006 in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle (BIDW). All patients will also receive 5 mg oral prednisone twice daily. Treatment in both cohorts will continue until disease progression, unacceptable toxicity, or discontinuation for any other reason. The end of the trial is defined as the time point when all subjects have discontinued trial treatment and have been given follow-up for safety measurements according to the trial assessment schedule.
Enrollment
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Volunteers
Inclusion criteria
Age ≥ 18 years
Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as:
Measurable tumour lesions, defined as pelvic and/or extra-pelvic nodal lesions ≥1.5 cm in the short axis or visceral lesions ≥1.0 cm in the longest dimensions and measurable according to RECIST v1.1, bone metastasis as evaluated with 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy
Resolution of toxicity of prior therapy to < grade 2 (except for alopecia), as defined by CTCAE v5.0
Adequate haematological, renal and hepatic functions:
World Health Organisation Performance Status (WHO-PS) of 0-2
Estimated life expectancy of at least 12 weeks
Able and willing to swallow oral medication
Able and willing to undergo radiologic scans (CT scan)
Able and willing to give written informed consent according to local guidelines
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
135 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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