Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GCS-100 · 4 trials · 2 indications
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
| Arm | Type | Description |
|---|---|---|
| Low Dose GCS-100 | EXPERIMENTAL | Low dose of GCS-100 |
| High Dose GCS-100 | EXPERIMENTAL | GCS-100 High dose |
| GCS-100 | EXPERIMENTAL | GCS-100: 160 mg/m2 IV (in the vein) Study Days 1-5 of each 21-day cycle |
| Placebo, saline | PLACEBO_COMPARATOR | Saline, dosed weekly for 8 weeks |
| GCS-100 low dose | EXPERIMENTAL | Low dose of GCS-100 given IV once per week for 8 weeks |
| GCS-100 high dose | EXPERIMENTAL | High dose of GCS-100 given IV once per week for 8 weeks |
| Name | Type | Description |
|---|---|---|
| GCS-100 | DRUG | 1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year. |
| Placebo, Saline | DRUG | The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL. |
Inclusion Criteria: 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent 2. Subject was enrolled in and completed the End of Study (Day 85) of GCS-100-CS-4002 Exclusion Criteria: 1. Subject experienced a Grade 3 or worse adverse...
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GCS-100 is an investigational small molecule being studied for chronic kidney disease and chronic lymphocytic leukemia. It has been evaluated in Phase 2 clinical trials in both indications. GCS-100 is not approved for any use and remains in clinical development.
GCS-100 is being developed by Innoviva, Inc., which trades under the ticker INVA. Innoviva is the sponsor associated with the clinical development program for GCS-100 across its studied indications.
GCS-100 is in Phase 2 development. Its clinical program includes Phase 2 studies in chronic kidney disease and chronic lymphocytic leukemia, along with an earlier Phase 1 safety study in chronic kidney disease. GCS-100 is investigational and has not been approved by the FDA.
GCS-100 has been studied in completed trials including NCT01843790, a Phase 2a study of weekly doses in chronic kidney disease; NCT02155673, a Phase 2 extension study; NCT01717248, a Phase 1 safety study in chronic kidney disease; and NCT00514696, a Phase 2 safety study in chronic lymphocytic leukemia.
Across its clinical program, 241 patients have been enrolled in GCS-100 trials. The chronic kidney disease studies enrolled 120, 92, and 29 patients respectively, while the chronic lymphocytic leukemia study enrolled 12 patients. All trials were conducted in the United States.