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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00547651 | AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy | PHASE3 | COMPLETED | 637 | — | — | Sep 1, 2007 | May 1, 2011 | Nov 6, 2019 | 140 | United States, Australia +15 |
| NCT00375193 | Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy | PHASE2 | COMPLETED | 75 | — | — | Nov 1, 2006 | Mar 1, 2009 | Oct 24, 2019 | 46 | United States, Netherlands +1 |
| NCT00388960 | Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer | PHASE2 | COMPLETED | 99 | — | — | Nov 1, 2006 | Dec 1, 2010 | Nov 19, 2019 | 25 | Belgium, Italy +3 |
| NCT00319969 | Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy. | PHASE2 | COMPLETED | 76 | — | — | Apr 1, 2006 | Jan 1, 2009 | Sep 30, 2009 | 47 | United States |
| Arm | Type | Description |
|---|---|---|
| Amrubicin | EXPERIMENTAL | Amrubicin |
| Topotecan | ACTIVE_COMPARATOR | Topotecan |
| 1 | EXPERIMENTAL | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial. |
| Amrubicin plus Cisplatin | EXPERIMENTAL | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression. |
| Cisplatin plus etoposide | ACTIVE_COMPARATOR | Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression. |
| 2 | ACTIVE_COMPARATOR | Topotecan 1.5mg/m\<2\> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression. |
| Name | Type | Description |
|---|---|---|
| Amrubicin | DRUG | Amrubicin for injection is supplied as 50-mg vials. Patients will receive 40 mg/m2 amrubicin as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course |
| Topotecan | DRUG | Topotecan for injection is supplied as 4-mg vials. Patients will receive 1.5 mg/m2 as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course |
| Cisplatin | DRUG | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression. Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
| Etoposide | DRUG | Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
Inclusion Criteria: * Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed; * SCLC that is either sensitive (defi...