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Peposertib + Radiation Therapy for Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Sarah L Davis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years

Summary

This trial is studying the side effects and best dose of M3814 given with radiation therapy to treat patients with localized pancreatic cancer.

Who is the study for?
Adults with localized pancreatic cancer that's inoperable but hasn't spread, who've completed 4-6 months of specific chemotherapy. They must be generally healthy, HIV or hepatitis B/C positive patients can join if their viral load is undetectable. Women of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
The trial tests M3814 (Peposertib) combined with hypofractionated radiation therapy versus radiation alone. The goal is to find the safest dose of M3814 and see if it's more effective when paired with this intense, short-term radiation treatment for pancreatic cancer.
What are the potential side effects?
Potential side effects include reactions related to blocking enzymes needed for cell growth which may affect tumor cells as well as normal cells leading to various organ-specific issues; also typical risks associated with radiation therapy such as skin irritation and fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival rate (Phase II)
Secondary study objectives
Disease control rate
Gene signature of tumor
Overall response rate
+3 more
Other study objectives
Gene signature of cell-free DNA from peripheral blood

Side effects data

From 2023 Phase 3 trial • 107 Patients • NCT03324802
80%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase II Group I (hypofractionated radiation therapy M3814)Experimental Treatment6 Interventions
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Group II: Phase I (hypofractionated radiation therapy, M3814)Experimental Treatment6 Interventions
Patients in Phase I undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Group III: Phase II Group II(hypofractionated radiation therapy, placebo)Placebo Group6 Interventions
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Peposertib
2021
Completed Phase 1
~20
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,962 Total Patients Enrolled
Sarah L DavisPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04172532 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Phase II Group II(hypofractionated radiation therapy, placebo), Phase I (hypofractionated radiation therapy, M3814), Phase II Group I (hypofractionated radiation therapy M3814)
Pancreatic Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04172532 — Phase 1 & 2
Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04172532 — Phase 1 & 2
~30 spots leftby Aug 2026
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