Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRT501 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 5g SRT501 | ACTIVE_COMPARATOR | 5.0 g of SRT501 will be administered once daily as an oral reconstituted powder, for 14 days at the same time each day. On Days 1 and 2, SRT501 will be administered approximately 15-30 minutes following the consumption of a standardized breakfast. On all other days, SRT501 will be administered approximately 15-30 minutes following the consumption of the evening meal. Following the course of SRT501 administration, subjects will undergo scheduled surgical removal of their metastatic liver disease as well as non-diseased tissue. Due to scheduling and surgical availability, subjects can receive SRT501 for a minimum of 10 days and a maximum of 21 days. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered once daily as an oral reconstituted powder, for 14 days at the same time each day. On Days 1 and 2, placebo will be administered approximately 15-30 minutes following the consumption of a standardized breakfast to allow for PK sample collection. On all other days, placebo will be administered approximately 15-30 minutes following the consumption of the evening meal. Following the course of placebo administration, subjects will undergo scheduled surgical removal of their metastatic liver disease as well as non-diseased tissue. Due to scheduling and surgical availability, subjects can receive placebo for a minimum of 10 days and a maximum of 21 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. Placebo must be used immediately following mixing. Placebo will be administered orally, once daily for 14 days. |
| SRT501 | DRUG | SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. The final drug product must be used immediately following mixing. SRT501 will be administered orally, once daily for 14 days. |
Inclusion Criteria: * Be male or female greater than 18 years of age. * Have histologically or cytologically confirmed and diagnosed colorectal cancer with hepatic metastases. * Have not received chemotherapy or anti-neoplastic therapy for a malignancy within six weeks of first dose of SRT501 or pl...
SRT501 is an investigational small molecule developed by GSK plc (ticker GSK) for the treatment of neoplasms and colorectal cancer. It has been studied in a Phase 1 clinical trial involving patients with colorectal cancer and hepatic metastases. SRT501 is not approved and remains in clinical development.
SRT501 was studied for use in patients with colorectal cancer and hepatic metastases, meaning cancer that has spread to the liver. The research focused on assessing safety, pharmacokinetics, and pharmacodynamics in this patient population rather than confirming efficacy. It is an investigational agent and is not an approved treatment.
SRT501 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical research evaluating SRT501 in oncology, specifically in patients with colorectal cancer and hepatic metastases. The compound is an investigational small molecule in the company's oncology pipeline.
SRT501 is in Phase 1 development. It has completed one Phase 1 clinical trial in patients with colorectal cancer and hepatic metastases. As a Phase 1 investigational agent, SRT501 has not been approved by the FDA or any other regulatory authority for commercial use.
SRT501 has been evaluated in one completed Phase 1 trial, NCT00920803, titled a study to assess the safety, pharmacokinetics, and pharmacodynamics of SRT501 in subjects with colorectal cancer and hepatic metastases. The trial enrolled 9 participants in the United Kingdom and was placebo-controlled, randomized, and double-blind.