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Alkylating agents

6,8-bis(benzylthio)octanoic acid for Pancreatic Adenocarcinoma

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 approximately 2 months after start of treatment
Awards & highlights

Study Summary

This trial is testing a new cancer drug (CPI-613) in combination with other chemotherapy drugs to treat metastatic pancreatic cancer.

Eligible Conditions
  • Pancreatic Carcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 months after start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 months after start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Clinical Response
Other outcome measures
Number of Participants with a Clinical Response
Number of Toxicities
Overall Survival
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 17 Patients • NCT01766219
100%
Chronic kidney disease
100%
Anemia
100%
Hyperglycemia
100%
Hypoalbuminemia
100%
Hyponatremia
100%
Nausea
100%
Pain
50%
Hypocalcemia
50%
Dyspnea
50%
Acute kidney injury
50%
Constipation
50%
Heart failure
50%
Activated partial thromboplastin time prolonged
50%
Alkaline phosphastase increased
50%
Anxiety
50%
Ascites
50%
Arthritis
50%
Atelectasis
50%
Atrial fibrillation
50%
Creatinine increased
50%
Dehydration
50%
Dysphagia
50%
Edema limbs
50%
Electrocardiogram QT corrected interval prolonged
50%
Esophageal infection
50%
Hallucinations
50%
Hypokalemia
50%
Hypoglycemia
50%
Aspartate aminotransferase increased
50%
Fatigue
50%
Hypophosphatemia
50%
Peripheral sensory neuropathy
50%
Platelet count decreased
50%
Hypomagnesemia
50%
Hypothyroidism
50%
Hypoxia
50%
Pleural effusion
50%
Oliguria
50%
Sleep apnea
50%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²
Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²
Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (6,8-bis[benzylthio]octanoic acid, mFOLFIRINOX)Experimental Treatment6 Interventions
Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 3. Patients also receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats 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
oxaliplatin
2002
Completed Phase 3
~6370
leucovorin calcium
1999
Completed Phase 3
~8620
fluorouracil
1994
Completed Phase 3
~8440
6,8-bis(benzylthio)octanoic acid
2013
Completed Phase 2
~100
irinotecan hydrochloride
1999
Completed Phase 3
~3030

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,244 Previous Clinical Trials
1,004,767 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,350 Total Patients Enrolled
Caio Rocha Lima, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Lancet OncologyJournal
Safety and Tolerability of the First-in-class Agent CPI-613 in Combination with Modified FOLFIRINOX in Patients with Metastatic Pancreatic Cancer: A Single-centre, Open-label, Dose-escalation, Phase 1 Trial
Alistar, Angela, Bonny B Morris, Rodwige Desnoyer, Heidi D Klepin, Keyanoosh Hosseinzadeh, Clancy Clark, Amy Cameron, et al.. 2017. “Safety and Tolerability of the First-in-class Agent CPI-613 in Combination with Modified FOLFIRINOX in Patients with Metastatic Pancreatic Cancer: A Single-centre, Open-label, Dose-escalation, Phase 1 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30314-5.
clinicaltrials.govStudy
CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer
2013. "CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01835041.
~2 spots leftby May 2025
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