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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00920803 | A Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases | PHASE1 | COMPLETED | 9 | — | — | Aug 19, 2008 | Nov 11, 2009 | Jun 14, 2017 | 1 | United Kingdom |
| 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...