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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02735980 | A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer | PHASE2 | COMPLETED | 133 | — | — | May 11, 2016 | Feb 12, 2019 | Mar 17, 2020 | 41 | United States, France +8 |
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
| Arm | Type | Description |
|---|---|---|
| Prexasertib (Platinum Sensitive Disease) | EXPERIMENTAL | 105 mg/m\^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy). |
| Prexasertib (Platinum Resistant Disease) | EXPERIMENTAL | 105 mg/m\^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum). |
| Prexasertib Exploratory Addendum (Platinum Sensitive Disease) | EXPERIMENTAL | 40 mg/m\^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease. |
| Name | Type | Description |
|---|---|---|
| Prexasertib | DRUG | Administered IV |
Inclusion Criteria: * Have ED-SCLC and have received a prior platinum-based regimen * Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum * Participants in Cohort 2 must...