CLINICAL TRIAL
Phase 1 tudy: This is listed under SRT501 rather than under resveratrol. In past studies Sirtris has given the dose resveratrol in SRT501, rather than SRT501 plus vehicle. The dose is 5 grams, for a two week period, 10 SRT501 subjects plus5 placebo controls. Estimated study completion date December 2009.
A Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases
This study is currently recruiting participants.
Verified by GlaxoSmithKline, June 2009
First Received: June 12, 2009 No Changes Posted
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00920803
Purpose
The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0 g) in subjects with colorectal cancer and hepatic metastases when administered once daily for 14 days.
The purpose is to also characterize the pharmacokinetic profile of SRT501 (5.0 g) by assessing levels of SRT501 and metabolites in blood, urine, bile and normal and malignant metastatic tissues in subjects with colorectal cancer and hepatic metastases when administered once daily for 14 days.
The secondary purpose is to examine the pharmacodynamics of SRT501 activity in both normal and malignant tissue samples, including blood and/or bodily fluids.
Condition Intervention Phase
Colorectal Cancer
Drug: SRT501
Drug: Placebo
Phase I
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title: A Phase 1, Double-Blind, Randomized Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases
Resource links provided by NLM:
MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Resveratrol
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
To characterize the pharmacokinetic profile of SRT501 in blood and normal and malignant metastatic tissues when administered once daily for 14 days. [ Time Frame: Pharmacokinetic samples will be obtained on Days 1, 2, 14, and 15. ] [ Designated as safety issue: No ]
To determine the safety and tolerability of SRT501 when administered once daily for 14 days. [ Time Frame: Safety will be continually assessed while subjects are on study. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
To examine the pharmacodynamics of SRT501 activity in both normal and malignant tissue samples and blood. [ Time Frame: Pharmacodynamic samples will be collected on Days 14 and 15 and will be analyzed at the end of the study. ] [ Designated as safety issue: No ]
Estimated Enrollment: 15
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: SRT501
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.
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.
Drug: Placebo
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.
Detailed Description:
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient study to assess the safety, pharmacokinetics, and pharmacodynamics of SRT501 in subjects diagnosed with colorectal cancer and hepatic metastases. Fifteen subjects aged 18 years of age and older who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Ten subjects, if eligible, will be randomized to receive SRT501 and 5 subjects, if eligible, will be randomized to receive placebo. Subjects will sign the informed consent form prior to any study-related procedures. If eligible, subjects will consent to receive 5.0 g of SRT501 or placebo, to be administered once daily as an oral reconstituted powder, for 14 days at the same time each day. On Days 1 and 2, SRT501 or 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, SRT501 or placebo will be administered approximately 15-30 minutes following the consumption of the evening meal. Following the course of SRT501 or placebo administration, subjects will undergo scheduled surgical removal of their metastatic liver disease as well as non-diseased tissue and these samples will be evaluated for SRT501 concentrations and pharmacodynamic markers of neoplastic activity (such as cell differentiation, apoptosis, proliferation, etc.). Due to scheduling and surgical availability, subjects can receive SRT501 or placebo for a minimum of 10 days and a maximum of 21 days. If diseased colon tissue is also scheduled to be removed during resection, both diseased and normal colon tissue will also be collected for analysis. Participants will be required to return to the study center on Day 2 for a 24-hour PK sample and the evening prior to their scheduled surgical resection as well as per the Institution's standards of care for recovery following the surgical procedure. . . .
Edited by maxwatt, 15 September 2009 - 11:21 AM.
