A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 15, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

June 30, 2026

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Ivaltinostat

Ivaltinostat (E)-N1-(3-(dimethylamino)propyl)-N8-hydroxy-2-((naphthalen-1-yloxy)methyl)oct-2-enediamide phosphate) is a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase (HDAC).

DRUG

Capecitabine

Capecitabine is labeled for monotherapy for the treatment of adjuvant Dukes' C colon cancer and metastatic colon cancer at a recommended dose of 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest. This dose schedule was effective and tolerable in the first line setting for patients with pancreatic cancer (Cartwright, 2002).

Trial Locations (16)

11590

RECRUITING

Clinical Research Alliance, Westbury

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

17033

RECRUITING

Penn State Hershey Cancer Institute, Hershey

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

30607

RECRUITING

University Cancer and Blood Center, Athens

40217

RECRUITING

Norton Cancer Institute Audubon, Louisville

46250

RECRUITING

Community Health Network, Indianapolis

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

70112

RECRUITING

University Medical Center New Orleans, New Orleans

75390

RECRUITING

The University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

84107

RECRUITING

Utah Cancer Specialists, Salt Lake City

85258

RECRUITING

HonorHealth Research Institute, Scottsdale

90404

RECRUITING

UCLA Hematology/Oncology, Gastrointestinal Oncology, Santa Monica

92663

RECRUITING

Hoag Medical Group, Newport Beach

94143

RECRUITING

UCSF Medical Center, San Francisco

Sponsors
All Listed Sponsors
lead

CG Pharmaceuticals, Inc

INDUSTRY