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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01876446 | Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer | PHASE2 | COMPLETED | 38 | — | — | Aug 29, 2013 | Feb 24, 2020 | Mar 17, 2020 | 3 | United States |
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
| Arm | Type | Description |
|---|---|---|
| Treatment (pegylated irinotecan NKTR 102) | EXPERIMENTAL | Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pegylated Irinotecan | DRUG | Given IV |
| Pharmacological Study | OTHER | Correlative studies |
Inclusion Criteria: * Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice * Histologic or cytologic diagnosis of SCLC (Note: patients wi...