At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed prostate cancer with progressive mCRPC (castrate testosterone ≤50 ng/dL, radiographic or PSA progression) with indication for docetaxel
- ✓Measurable disease per RECIST v1.1 (nodal ≥1.5 cm short axis, visceral ≥1.0 cm longest dimension) or bone metastases on imaging
- ✓WHO Performance Status 0–2
- ✓Adequate bone marrow function: hemoglobin ≥6.0 mmol/L (>9.6 g/dL), ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L
- ✕Prior taxane therapy
- ✕Symptomatic brain metastases; asymptomatic brain metastases allowed only if off corticosteroids/anticonvulsants ≥6 weeks, radiotherapy ≥6 weeks prior, and stable on imaging; leptomeningeal metastases excluded
- ✕Grade ≥2 peripheral neuropathy (motor or sensory)
- ✕Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre Phase 2b Trial to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC), Suitable for Treatment With a Taxane
In Brief
A Phase 2 clinical trial evaluating Docetaxel in Parenteral Dosage Form and ModraDoc006/r for Prostate Cancer Metastatic and Castration-resistant Prostate Cancer. Completed, enrolled 135 participants across 28 sites in 6 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Treatment with IV docetaxel at 75 mg/m2 given as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily
Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets