M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02595931
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Carcinoma
  • Metastatic Lung Small Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Pancreatic Carcinoma
  • Refractory Colorectal Carcinoma
  • Refractory Lung Small Cell Carcinoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Pancreatic Carcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Unresectable Colorectal Carcinoma
  • Unresectable Lung Small Cell Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Pancreatic Carcinoma

Eligibility Criteria

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

Interventions

  • Berzosertib — DRUG
    Given IV
  • Biopsy Specimen — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Irinotecan Hydrochloride — DRUG
    Given IV

Study Details

This phase I trial studies the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). M6620 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jul 22, 2016
Status verified
Mar 2026
Primary completion
Mar 7, 2023
Completion
Mar 6, 2027

Study Design

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

Arms

  • Experimental: Treatment (irinotecan, M6620)
    Patients receive irinotecan hydrochloride IV over 90 minutes and M6620 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy and collection of blood samples throughout the study and undergo CT at screening, throughout the study, and during follow up.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 28 days ]

Locations (23)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
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-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Los Angeles, CA

By research site
Los Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Institute Palo Alto· Palo Alto, CAKeck Medical Center of USC Pasadena· Pasadena, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCSF Medical Center-Mount Zion· San Francisco, CA

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