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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00732810 | SCH 727965 in Patients With Advanced Breast and Lung Cancers (Study P04716) | PHASE2 | COMPLETED | 97 | — | — | Jul 1, 2008 | Jun 1, 2011 | Aug 5, 2015 | - | — |
Date of randomization to date of tumor progression.
Percentage of participants with tumor responses (partial responses + complete responses).
| Arm | Type | Description |
|---|---|---|
| Breast cancer randomized to SCH 727965 | EXPERIMENTAL | - |
| Breast cancer randomized to capecitabine | ACTIVE_COMPARATOR | - |
| SCH 727965 in breast cancer after progression on capecitabine | EXPERIMENTAL | - |
| NSCLC randomized to SCH 727965 | EXPERIMENTAL | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| NSCLC randomized to erlotinib | ACTIVE_COMPARATOR | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| SCH 727965 in NSCLC after progression on erlotinib | EXPERIMENTAL | Note: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010 |
| Name | Type | Description |
|---|---|---|
| SCH 727965 | DRUG | SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression. |
| Capecitabine | DRUG | Capecitabine 1250 mg/m\^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression. |
| Erlotinib | DRUG | Erlotinib 150 mg orally once daily until disease progression. |
Inclusion Criteria: * Age \>=18 years, either sex, any race. * Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease. * BREAST CANCER: * participant must have previously received both a taxane and an anthracycline (unless anthracycline ...