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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00390806 | Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer | PHASE3 | COMPLETED | 472 | — | — | Dec 1, 2006 | Sep 1, 2013 | Jan 20, 2014 | 88 | United States, Canada +4 |
Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.
| Arm | Type | Description |
|---|---|---|
| topotecan plus radiation | EXPERIMENTAL | topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy. |
| Whole brain radiation | ACTIVE_COMPARATOR | Whole brain radiation 3 Gy/day for 10 days |
| Name | Type | Description |
|---|---|---|
| HYCAMTIN, oral capsules | DRUG | topotecan oral capsules 1.1 mg/m2 |
| Radiation | RADIATION | Whole brain radiation |
Inclusion criteria: * At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC) * Must have received previous chemotherapy * Must be 18 years of age of greater * Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2 * At least 2 week...