Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04750954
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neuroendocrine Neoplasm

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Lutetium Lu 177 Dotatate — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Peposertib — DRUG
    Given PO

Study Details

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of peposertib when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell formation, so as to help block the formation of growths that may become cancer. Radioactive drugs, such as lutetium Lu 177 dotatate, may deliver radiation directly to tumor cells and not harm normal cells. Adding peposertib to lutetium Lu 177 dotatate may kill more tumor cells.

Key Dates

Start date
Jul 22, 2021
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: Treatment (peposertib, lutetium Lu 177 dotatate)
    Patients receive peposertib PO QD or BID on days 1-21 and lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI throughout the trial and undergo collection of blood samples on study.

Primary Outcome Measure

Recommended phase 2 dose [ Time Frame: Up to 8 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLUniversity of Kentucky/Markey Cancer Center· Lexington, KYOhio State University Comprehensive Cancer Center· Columbus, OHHuntsman Cancer Institute/University of Utah· Salt Lake City, UT

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