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Fluoropyrimidine Analog
Ivaltinostat + Capecitabine for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By Andrew H. Ko, MD
Research Sponsored by CG Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: ≥18 years
For Phase 2, treatment with FOLFIRINOX for metastatic pancreatic adenocarcinoma at full or modified doses, for a minimum of 16 weeks, and no evidence of progression based on the radiographic imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 months
Awards & highlights
Study Summary
This trial is testing ivaltinostat, a new drug, to see if it is effective and safe to use in combination with capecitabine to treat patients with metastatic pancreatic adenocarcinoma.
Who is the study for?
Adults with metastatic pancreatic adenocarcinoma who responded well to initial FOLFIRINOX chemotherapy without disease progression are eligible. They must have adequate organ function, good performance status (ECOG 0-1), and can join within 6 weeks of their last chemo dose. Prior treatments for other cancers or radiation therapy are okay if enough time has passed.Check my eligibility
What is being tested?
The trial is testing ivaltinostat combined with capecitabine versus capecitabine alone in patients whose cancer hasn't worsened after first-line chemotherapy. It's a two-phase study: the first determines the best dose of ivaltinostat, and the second compares both treatment methods.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems, and potential liver or kidney function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I've been treated with FOLFIRINOX for pancreatic cancer for at least 16 weeks without the cancer getting worse.
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I had chemotherapy or chemoradiation over a year ago for a different or earlier stage of pancreatic cancer.
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I am fully active or can carry out light work.
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I either have measurable cancer, or scans show no cancer but I've had treatment.
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My pancreatic cancer hasn't worsened on my first chemo treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) in phase 1
Incidence of treatment emergent AEs in phase 1
Progression-Free Survival (PFS) in Phase 2
+1 moreSecondary outcome measures
AUC of ivaltinostat in Phase 1 and 2
Cmax of ivaltinostat in Phase 1 and 2
Half-life (T1/2) of ivaltinostat in Phase 1 and 2
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ivaltinostat plus CapecitabineExperimental Treatment2 Interventions
Ivaltinostat plus Capecitabine
Group II: Capecitabine MonotherapyActive Control1 Intervention
Capecitabine Monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
CG Pharmaceuticals, IncLead Sponsor
Andrew H. Ko, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
3 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by standard health scans.I have never been treated with a HDAC inhibitor, including ivaltinostat.I have had more than one treatment for my advanced pancreatic cancer.I am 18 years old or older.My pancreatic cancer has worsened after starting FOLFIRINOX chemotherapy.I've been treated with FOLFIRINOX for pancreatic cancer for at least 16 weeks without the cancer getting worse.I have pancreatic cancer that has spread, and I've had at least one treatment before.I had chemotherapy or chemoradiation over a year ago for a different or earlier stage of pancreatic cancer.I am fully active or can carry out light work.I haven't had chemotherapy or targeted therapy in the last 28 days and completed any palliative radiotherapy at least 14 days ago.I am not on FOLFIRINOX for my metastatic pancreatic cancer, or I stopped it due to side effects but completed 2 cycles.I either have measurable cancer, or scans show no cancer but I've had treatment.My organs are working well.I finished my radiation therapy more than 14 days ago.I finished my chemotherapy less than 6 weeks ago and had no signs of cancer after stopping early due to side effects.My pancreatic cancer hasn't worsened on my first chemo treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ivaltinostat plus Capecitabine
- Group 2: Capecitabine Monotherapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum amount of people allowed to enroll in this clinical trial?
"That is correct. Based on the information available from clinicaltrials.gov, it appears that this particular trial is still recruiting patients. The original posting date was July 1st, 2022 and the most recent update was September 30th, 2022. There are 4 different locations where this study is taking place and they hope to enroll a total of 70 individuals."
Answered by AI
What are the goals that researchers hope to achieve with this trial?
"The primary outcome of this study is the incidence of dose-limiting toxicities (DLTs) over the course of 15 months. Secondary outcomes that will be evaluated include AUC of ivaltinostat, T1/2 of ivaltinostat, and objective response rate (ORR)."
Answered by AI
Are we still enrolling people in this experiment?
"That is accurate. The clinicaltrials.gov website includes information revealing that this trial is recruiting patients. This specific study was posted on July 1st, 2020 and updated last September 30th, 2020. The research requires a total of 70 participants from 4 different locations."
Answered by AI
At how many hospitals is this research being conducted?
"4 hospitals are currently enrolling patients for this study. The locations include Buffalo, New Orleans, Detroit and 4 other unnamed cities. If you are planning on participating in the trial, it would be best to choose a location near to reduce travel time and expenses."
Answered by AI
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