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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

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

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

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

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Peposertib

2021

Completed Phase 1

~20

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,958 Previous Clinical Trials

41,112,482 Total Patients Enrolled

Sarah L DavisPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

$Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04172532 — Phase 1 & 2$

$Pancreatic Cancer Research Study Groups: Phase II Group II(hypofractionated radiation therapy, placebo), Phase I (hypofractionated radiation therapy, M3814), Phase II Group I (hypofractionated radiation therapy M3814)$