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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01438307 | Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 28 | — | — | Sep 1, 2011 | Sep 1, 2015 | May 24, 2017 | 2 | United States |
The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Schedule A | EXPERIMENTAL | Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases. |
| Schedule B | EXPERIMENTAL | Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases. |
| Name | Type | Description |
|---|---|---|
| Cabazitaxel-XRP6258 (3-week cycle) | DRUG | Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator. |
| Cabazitaxel-XRP6258 (5-week cycle) | DRUG | Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator. |
Inclusion Criteria: * Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified) * Subjects who have failed first line chemotherapy (platinum doublets or non- platinum doublets \[previous taxane exposure is allowed\]) for Stage IV NSCLC. * Measurable disease as def...