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 being studied for the treatment of neoplasms, specifically colorectal cancer. It was evaluated in a Phase 1 clinical trial in subjects with colorectal cancer and hepatic metastases. The drug is not approved and remains in clinical development.
SRT501 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company conducted a Phase 1 clinical trial of SRT501 in the United Kingdom.
SRT501 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
SRT501 has been studied in one completed clinical trial, NCT00920803, titled 'A Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases.' This Phase 1 trial enrolled 9 participants in the United Kingdom.
Yes, the Phase 1 clinical trial of SRT501 was randomized and double-blind, with a placebo-controlled design. The trial enrolled 9 participants and was biomarker-selected, meaning participants were chosen based on specific biomarkers.