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Radioactive Drug
Peposertib + Radiation Therapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Lowell Anthony
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
Age >= 18 years
Failure of at least one prior systemic cancer treatment with somatostatin analogs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-treatment
Awards & highlights
Study Summary
This trial is to find out the benefits and side effects of peposertib and lutetium Lu 177 dotatate in treating neuroendocrine tumors. Peposertib may stop the growth of tumor cells and lutetium Lu 177 dotatate may deliver radiation directly to tumor cells.
Who is the study for?
Adults with well-differentiated pancreatic neuroendocrine tumors, who've had a positive dotatate scan and failed at least one cancer treatment. They must have good organ function, no prior radionuclide therapy, be able to swallow pills, not pregnant or breastfeeding, and without serious infections or psychiatric issues that could affect participation.Check my eligibility
What is being tested?
The trial is testing the combination of M3814 (Peposertib) with Lutetium Lu 177 Dotatate radiation therapy to determine the best dose and assess potential benefits and side effects in treating neuroendocrine tumors. Peposertib blocks enzymes needed for cell growth while the radioactive drug targets tumor cells.See study design
What are the potential side effects?
Possible side effects include reactions related to blocking cell growth enzymes by peposertib which might affect normal cellular functions, as well as radiation-related effects from Lutetium Lu 177 Dotatate that may cause damage to both tumor and potentially some normal cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have tried a cancer treatment involving somatostatin analogs without success.
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I have never had peptide receptor radionuclide therapy.
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I have chronic hepatitis B but it's under control with medication.
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I will avoid pregnancy or fathering a child for the required period after my last lutetium treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I had hepatitis C but am now cured or currently being treated with an undetectable viral load.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
Recommended phase 2 dose
Secondary outcome measures
Overall response rate
Overall survival
Progression free survival
Other outcome measures
Krenning score from the gallium 68 or copper 64 dotatate
Pharmacokinetic (PK) analysis
Radiographic expression of somatostatin receptors
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (peposertib, lutetium Lu 177 dotatate)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Peposertib
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,124 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,594 Patients Enrolled for Neuroendocrine Tumors
Lowell AnthonyPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors
Aman ChauhanPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
123 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
123 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have stopped taking long-acting somatostatin analogs for 4 weeks.I have a heart condition and have been assessed using the NYHA classification.I cannot swallow pills or have a condition that affects how my body absorbs medication.I have not had major surgery in the last 4 weeks.I have received PRRT-based treatments before.I have not had a live vaccine or an active infection in the last 4 weeks.I do not have any unmanaged ongoing illnesses.I am HIV-positive, on treatment, and my viral load is undetectable.My brain metastases have been treated and stable for over 4 weeks.I am allergic to certain cancer drugs similar to M3814 or lutetium Lu 177 dotatate.I cannot stop taking my acid reflux medication.My scans show my cancer has grown according to specific criteria.I have tried a cancer treatment involving somatostatin analogs without success.I have never had peptide receptor radionuclide therapy.I have another cancer that won't affect this treatment's safety or results.I have chronic hepatitis B but it's under control with medication.I have recovered from side effects of previous treatments to a mild level.I have had extensive radiation therapy affecting most of my bone marrow.I cannot stop taking certain medications or supplements that affect my liver enzymes.My tumor is a well-differentiated neuroendocrine type and had a positive dotatate scan recently.I will avoid pregnancy or fathering a child for the required period after my last lutetium treatment.I can take care of myself but might not be able to do heavy physical work.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I had hepatitis C but am now cured or currently being treated with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (peposertib, lutetium Lu 177 dotatate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment period for this study still open?
"Affirmative. Clinicaltrials.gov substantiates that the trial, which was initially launched on June 4th 2021, is presently enrolling participants. 15 individuals must be recruited from 4 distinct medical centres."
Answered by AI
Has the FDA greenlit Peposertib for public use?
"At Power, the safety of peposertib was scored a 1 due to its current Phase 1 status; there is minimal evidence supporting its efficacy and security."
Answered by AI
How many hubs are overseeing this experiment?
"This clinical trial is currently taking place in various centres, including Ohio State University Comprehensive Cancer Center (Columbus), Huntsman Cancer Institute/University of Utah (Salt Lake City) and City of Hope Comprehensive Cancer Centre (Duarte). Additionally, there are 4 other locations."
Answered by AI
What is the cap of participants in this clinical trial?
"This research project necessitates 15 qualified enrollees. Ohio State University Comprehensive Cancer Center in Columbus, Ohio and Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah are two sites that offer participants the chance to partake."
Answered by AI
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