What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as capecitabine and Histone Deacetylase Inhibitors like Ivaltinostat, often result in side effects including fatigue, nausea, vomiting, diarrhea, and hematologic toxicities such as thrombocytopenia and neutropenia. Capecitabine specifically can also cause hand-foot syndrome, characterized by redness, swelling, and pain on the palms of the hands or soles of the feet.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy regimens. Notably, gemcitabine was approved for first-line therapy due to its significant improvements in clinical benefit and survival. Combination therapies such as FOLFIRINOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine plus nab-paclitaxel have shown clear survival benefits over single-agent therapies. While the provided context does not mention specific FDA approvals for histone deacetylase inhibitors like ivaltinostat in pancreatic cancer, these agents are being studied for their potential efficacy in combination with other chemotherapeutic agents.

What other types of research exist?

Promising novel alternatives to Ivaltinostat for pancreatic cancer patients include other HDAC inhibitors such as Panobinostat and Abexinostat, which have shown potential in clinical research. Additionally, combination therapies involving HDAC inhibitors and other agents, such as VS-5584 combined with Panobinostat, may offer new treatment strategies, especially for relapsed or refractory cases.

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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

Must not have

Any previous treatment with a HDAC inhibitor, including ivaltinostat

For Phase 2, more than 1 prior line of therapy for metastatic PDAC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 19 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests ivaltinostat with capecitabine in patients with advanced pancreatic cancer who have not worsened after initial treatment. The goal is to find a safe and effective dose and to see if this combination can better control the cancer. Capecitabine is a medication that is converted into another drug in the body, showing better selectivity and tolerability in tumor tissues.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with a HDAC inhibitor, including ivaltinostat.

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I have had more than one treatment for my advanced pancreatic cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

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.

Trial 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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pancreatic cancer treatments often involve a combination of chemotherapy, targeted therapy, and emerging agents like Histone Deacetylase Inhibitors (HDACi). HDAC inhibitors, such as Ivaltinostat, work by altering the expression of genes involved in cancer cell growth and survival, making cancer cells more susceptible to other treatments. Chemotherapy agents like capecitabine and gemcitabine interfere with DNA synthesis, preventing cancer cells from replicating. Targeted therapies, including PARP inhibitors for patients with specific genetic mutations, block pathways critical for cancer cell repair and survival. These treatments are crucial as they offer multiple mechanisms to attack cancer cells, potentially improving outcomes and providing options for patients with advanced or resistant pancreatic cancer.