CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05685602
Phase
PHASE1
Status
Suspended

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Unresectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsies
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Emavusertib — BIOLOGICAL
    Given PO
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Nab-paclitaxel — DRUG
    Given IV

Study Details

This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). CA-4948 is in a class of medications called kinase inhibitors. It works by blocking the action of abnormal proteins called interleukin-1 receptor-associated kinase 4 (IRAK4) and FMS-like tyrosine kinase 3 (FLT3) that signal cells to multiply. This may help keep cancer cells from growing. The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.

Key Dates

Start date
Jun 12, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CA-4948, gemcitabine, nab-paclitaxel)
    Patients receive CA-4948 PO BID on days 1-21 or 1-28 of each cycle, gemcitabine IV over 30-60 minutes on days 1 and 8 or 1, 8, and 15 of each cycle, and nab-paclitaxel IV over 30-40 minutes on days 1 and 8 or 1, 8, and 15 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, tumor biopsies, and blood sample collection throughout the trial.

Primary Outcome Measure

Dose limiting toxicity rate [ Time Frame: Up to 1 year ]

Locations (26)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCHealth University of Colorado HospitalAuroraColorado80045-
Northwestern UniversityChicagoIllinois60611-
Memorial Hospital EastShilohIllinois62269-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
NYU Langone Hospital - Long IslandMineolaNew York11501-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Cincinnati Cancer Center-West ChesterWest ChesterOhio45069-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

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By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUCHealth University of Colorado Hospital· Aurora, CONorthwestern University· Chicago, ILMemorial Hospital East· Shiloh, IL

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