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Mitochondrial Inhibitor

6,8-bis(benzylthio)octanoic acid for Adenocarcinoma of the Rectum

Phase 1

Waitlist Available

Led By Caio Rocha Lima, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug (CPI-613) to see if it's effective and has minimal side-effects when given with another cancer drug (fluorouracil).

Eligible Conditions

Colorectal Adenocarcinoma
Adenocarcinoma of the Rectum
Colorectal Cancer
Rectal Cancer
Adenocarcinoma of the Colon
Colon Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MTD of 6,8-bis(benzylthio)octanoic acid in combination with fluorouracil based on the incidence of dose-limiting toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Secondary outcome measures

Incidence of toxicity of 6,8-bis(benzylthio)octanoic acid and fluorouracil combination graded according to NCI CTCAE version 4.0

PK parameters (maximum observed concentration, area under the curve, half-life, elimination rate constant, drug clearance, and volume of distribution) of 6,8-bis(benzylthio)octanoic acid in plasma samples

Other outcome measures

Disease control rate (DCR) (i.e., sum of CR, PR, and stable disease)

Overall response rate (ORR) (i.e., sum of complete response [CR] and partial response [PR])

Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (6,8-bis(benzylthio)octanoic acid, fluorouracil)Experimental Treatment4 Interventions

Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-4 and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 2 weeks for 6 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

6,8-bis(benzylthio)octanoic acid

2013

Completed Phase 2

~100

fluorouracil

1994

Completed Phase 3

~8440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,253 Total Patients Enrolled

20 Trials studying Adenocarcinoma of the Rectum

14,403 Patients Enrolled for Adenocarcinoma of the Rectum

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,218 Total Patients Enrolled

Caio Rocha Lima, MDPrincipal InvestigatorWake Forest University Health Sciences

3 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which experiments have made use of 6,8-bis(benzylthio)octanoic acid?

"At present, there are 326 studies for 6,8-bis(benzylthio)octanoic acid with 103 of those being in Phase 3. While the majority of research is based out of Adelaide, South Australia, a total 17907 medical centres are running investigations into this treatment."

Answered by AI

For what health-related reasons is 6,8-bis(benzylthio)octanoic acid typically prescribed?

"6,8-bis(benzylthio)octanoic acid effectively manages type 2 diabetes mellitus, treats actinic keratosis and can be used to supplement nutrition."

Answered by AI

How many individuals are being recruited for participation in this investigation?

"This clinical trial has ceased recruitment. It was first made available on January 6th 2015, and its most recent update occurred on September 13th 2022. For those seeking other medical experiments, there are currently 2165 trials actively recruiting patients with mucinous adenocarcinoma and 326 studies accepting participants for 6,8-bis(benzylthio)octanoic acid treatments."

Answered by AI

What potential risks exist with the utilization of 6,8-bis(benzylthio)octanoic acid in treatments?

"We at Power have assessed 6,8-bis(benzylthio)octanoic acid's safety to be a 1 on the scale of 1 to 3 due to its Phase 1 status. This implies that there is only limited data demonstrating its efficacy and safety."

Answered by AI

Are there any available slots for this research endeavor?

"According to clinicaltrials.gov, recruitment for this medical trial has been concluded as of September 13th 2022 - despite first being posted on June 1st 2015. Nevertheless, there are still 2491 other trials recruiting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

2015. "CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02232152.