Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03641313
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Unresectable Gastric Adenocarcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Berzosertib — DRUG
    Given IV
  • Computed Tomography Assisted Biopsy — PROCEDURE
    Undergo CT assisted biopsy
  • Endoscopic Biopsy — PROCEDURE
    Undergo endoscopic biopsy
  • Irinotecan — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase II trial studies the how well berzosertib and irinotecan work in treating patients with gastric or gastroesophageal junction cancer that is growing, spreading or getting worse (progressive), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for growth. Chemotherapy drugs, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving berzosertib and irinotecan may work better than irinotecan alone in treating patients with gastric and gastroesophageal junction cancer.

Key Dates

Start date
Nov 16, 2020
Status verified
Jan 2026
Primary completion
Jul 1, 2024
Completion
Jan 28, 2027

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan and M6620)
    Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.

Primary Outcome Measure

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Criteria [ Time Frame: Up to 1 year ]

Locations (31)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Clinical Research CenterFairwayKansas66205-
HaysMedHaysKansas67601-
Lawrence Memorial HospitalLawrenceKansas66044-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
Mercy Hospital PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University Health Truman Medical CenterKansas CityMissouri64108-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Wake Forest University at ClemmonsClemmonsNorth Carolina27012-
Wake Forest Baptist Health - Wilkes Medical CenterWilkesboroNorth Carolina28659-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FL

Related Studies