Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00917748 | Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF) | PHASE3 | COMPLETED | 84 | — | — | Jun 1, 2009 | Mar 1, 2011 | Sep 26, 2012 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | docetaxel chemotherapy + modafinil 100 mg capsules |
| 2 | PLACEBO_COMPARATOR | docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug) |
| Name | Type | Description |
|---|---|---|
| DOCETAXEL(XRP6976) + MODAFINIL | DRUG | arm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily |
| Modafinil | DRUG | best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily |
| Placebo of Modafinil | DRUG | Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon) |
Inclusion criteria: * Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2 * Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based che...