Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CS-7017 · 2 trials · 1 indication
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...
CS-7017 is an investigational small molecule being studied for the treatment of carcinoma, non-small-cell lung cancer (NSCLC). It is in Phase 1 clinical development and is not yet approved. The drug is being evaluated in combination with other therapies for patients with stage IIIb/IV NSCLC.
CS-7017 is being developed by Icon Plc, a company traded on the NASDAQ under the ticker ICLR. The drug is currently in Phase 1 clinical development for non-small-cell lung cancer.
CS-7017 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving patients with stage IIIb/IV non-small-cell lung cancer.
CS-7017 has been studied in two completed Phase 1 trials. NCT01199055 tested CS-7017 in combination with carboplatin and paclitaxel in 16 patients with stage IIIb/IV NSCLC. NCT01199068 tested CS-7017 with erlotinib in 15 patients with the same condition. Both trials were conducted in South Korea.
No alternative names for CS-7017 have been disclosed. The drug is identified by its code name CS-7017 in clinical trials and is being developed by Icon Plc for non-small-cell lung cancer.