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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01199068 | CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC) | PHASE1 | COMPLETED | 15 | — | — | Jun 1, 2010 | Dec 1, 2011 | May 13, 2021 | 1 | South Korea |
| NCT01199055 | CS-7017 in Combination With Carboplatin/Paclitaxel in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC) | PHASE1 | COMPLETED | 16 | — | — | Mar 1, 2010 | Jul 1, 2011 | Jul 7, 2020 | 1 | South Korea |
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.
After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.
After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.
After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.
The area under the concentration versus time curve during dosing interval (AUCtau) and up to the last quantifiable time (AUClast) of geometric means of CS-7017 are reported at selected cycles (C) and days (D).
The maximum serum concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
The time of maximum plasma concentration (including at steady state (ss) of CS-7017 are reported at selected cycles (C) and days (D).
Treatment-emergent adverse events (TEAEs) are defined as those adverse events that occur, having been absent before the study, or worsen in severity after the initiation of study drug.
| Arm | Type | Description |
|---|---|---|
| CS-7017+Erlotinib | EXPERIMENTAL | Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily |
| CS-7017+Carboplatin/Paclitaxel | EXPERIMENTAL | Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) |
| Name | Type | Description |
|---|---|---|
| CS-7017 | DRUG | CS-7017 from 0.25 mg to 0.50 mg twice daily |
| Erlotinib | DRUG | Erlotinib 150 mg once daily |
| Carboplatin | DRUG | Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) |
| Paclitaxel | DRUG | Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) |
Inclusion Criteria: * Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC) * Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-l...