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Radioactive Drug
Sunitinib + Lutathera for Pancreatic Cancer
Phase 1
Recruiting
Led By Nikolaos Trikalinos
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
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks
Awards & highlights
Study Summary
This trial tests the safety & effectiveness of 2 drugs for pancreatic tumor treatment; one blocks a protein, the other delivers radiation only to tumor cells.
Who is the study for?
Adults with well- or moderately-differentiated pancreatic neuroendocrine tumors that are metastatic/unresectable, who have had up to one line of systemic therapy (excluding somatostatin analogs), and can swallow pills. They must not be pregnant, agree to use contraception, and have adequate organ function. Excluded are those with certain heart conditions, uncontrolled illnesses, recent serious cardiovascular events, or prior treatment with similar drugs.Check my eligibility
What is being tested?
The trial is testing the combination of Sunitinib Malate (a kinase inhibitor) and Lutetium Lu 177 Dotatate (a radioactive drug targeting tumor cells) for safety and effectiveness in treating pancreatic neuroendocrine tumors. It's a phase I study determining the best dose while monitoring side effects.See study design
What are the potential side effects?
Potential side effects include risks from radiation exposure to normal cells despite targeted therapy; adverse reactions related to kinase inhibition such as high blood pressure; fatigue; digestive issues; skin problems; mouth sores; hand-foot syndrome; changes in hair color or loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hepatitis B is under control with 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 cured, or I'm being treated with no detectable virus.
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My scans show I'm a candidate for a specific radioactive drug treatment.
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My pancreatic cancer is advanced and cannot be removed by surgery.
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I am 18 years old or older.
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My kidney function, measured by creatinine clearance or GFR, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time from first documentation of response (cr or pr) until the time of first documentation of disease progression by recist v1.1, assessed up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Chromogranin A levels
Duration of response
Intensity of tumor uptake
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sunitinib malate, lutetium Lu 177 dotatate)Experimental Treatment6 Interventions
Patients receive sunitinib malate PO QD from day 1 of lutetium 177 dotatate therapy to 28 days after the last dose of lutetium 177 dotatate in the absence of unacceptable toxicity. Patients also receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat Q8W for 4 cycles in the absence of unacceptable toxicity. Patients undergo a CT scan and/or MRI throughout the trial. Patients also undergo a SSR PET/CT scan during screening and blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Sunitinib Malate
2008
Completed Phase 3
~3070
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,417 Total Patients Enrolled
Nikolaos TrikalinosPrincipal InvestigatorYale University Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hepatitis B is under control with treatment.I can take care of myself but might not be able to do heavy physical work.You are currently taking any other experimental medications.My heart function is classified as class 2B or better according to the NYHA.You cannot participate if you have certain health conditions like serious wounds, history of specific heart or blood vessel issues, uncontrolled illness, or if you are pregnant or breastfeeding.I agree to use birth control during and after the study.My blood pressure is under 140/90 mmHg, or it's controlled to be under this with medication.You need to have a certain amount of a type of white blood cell called neutrophils in your blood.Your hemoglobin level is higher than 8.0 grams per deciliter.Your blood calcium level is no higher than 12.0 mg/dL.I am allergic to medications similar to sunitinib malate or lutetium Lu 177 dotatate.I had hepatitis C but am cured, or I'm being treated with no detectable virus.My scans show I'm a candidate for a specific radioactive drug treatment.You must have at least 75,000 platelets per microliter of blood.My pancreatic cancer is advanced and cannot be removed by surgery.I am HIV positive, on treatment, and my viral load is undetectable.I am 18 years old or older.Your white blood cell count is higher than 2000 per milliliter.My cancer has worsened within a year since starting the study treatment.Your AST and ALT levels in your blood should not be more than three times the normal limit.My kidney function, measured by creatinine clearance or GFR, is within the normal range.I have recovered from serious side effects of cancer treatment, except for hair loss.Your bilirubin level is not higher than the normal range set by the hospital.I have tried one treatment for my condition and may have had side effects or it didn't work. I can be on somatostatin analog therapy.My brain cancer has not worsened after treatment and I haven't taken steroids for a month.I am not on high doses of blood thinners like warfarin, but low doses or heparin are okay.I can swallow and retain medication without issues.I have another cancer type, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sunitinib malate, 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 Treatment (sunitinib malate, lutetium Lu 177 dotatate) deemed as a secure option for individuals?
"Our experts at Power have assigned Treatment (sunitinib malate, lutetium Lu 177 dotatate) a safety ranking of 1 due to the preliminary nature of Phase 1 trials and limited evidence for both its efficacy and risk profile."
Answered by AI
How many people are enrolled in the research project?
"Affirmative. According to information displayed on clinicaltrials.gov, this medical testing is actively recruiting with an initial post date of June 14th 2023 and the most recent update having occurred July 8th 2023. 24 participants are needed from one location."
Answered by AI
Are there any vacancies for volunteers in this investigation?
"This trial, which was initially posted on June 14th 2023, is currently recruiting according to the clinicaltrials.gov database and has been recently updated on July 8th 2023."
Answered by AI
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