Study Summary
This trial is studying the side effects and best dose of M3814 given with radiation therapy to treat patients with localized pancreatic cancer.
Eligible Conditions
- Pancreatic Cancer
- Pancreatic Cancer Locally Advanced
- Unresectable Pancreatic Cancer
- Stage IIA Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage II Pancreatic Cancer
- Stage IIB Pancreatic Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
3 Primary · 6 Secondary · Reporting Duration: At 2 years
At 2 years
Two-year OS
Baseline and after treatment
Gene signature of cell-free DNA from peripheral blood
Year 2
Overall survival (OS)
Year 2
Progression-free survival rate (Phase II)
Up to 14 days
Maximum tolerated dose (Phase I)
Recommended phase 2 dose (Phase I)
Up to 2 years
Disease control rate
Gene signature of tumor
Overall response rate
Pharmacokinetic markers of M3814
Trial Safety
Phase-Based Safety
Trial Design
3 Treatment Groups
Phase I (hypofractionated radiation therapy, M3814)
1 of 3
Phase II Group I (hypofractionated radiation therapy M3814)
1 of 3
Phase II Group II(hypofractionated radiation therapy, placebo)
1 of 3
Experimental Treatment
Non-Treatment Group
98 Total Participants · 3 Treatment Groups
Primary Treatment: Hypofractionated Radiation Therapy · Has Placebo Group · Phase 1 & 2
Phase I (hypofractionated radiation therapy, M3814)Experimental Group · 6 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Peposertib, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Radiation
Phase II Group I (hypofractionated radiation therapy M3814)Experimental Group · 6 Interventions: Biopsy, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Peposertib, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Radiation
Phase II Group II(hypofractionated radiation therapy, placebo)PlaceboComparator Group · 6 Interventions: Biopsy, Placebo Administration, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Hypofractionated Radiation Therapy · Intervention Types: Procedure, Other, Procedure, Procedure, Procedure, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Nedisertib
Not yet FDA approved
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,278 Previous Clinical Trials
41,234,732 Total Patients Enrolled
Sarah L DavisPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
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