- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05724108
Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors
A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. Evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of combination triapine + lutetium Lu 177 dotatate (treatment arm 1) versus standard of care lutetium Lu 177 dotatate alone (treatment arm 2).
SECONDARY OBJECTIVE:
I. Evaluate progression-free survival (PFS) between the two treatment arms (combination arm 1 versus standard of care arm 2).
EXPLORATORY OBJECTIVES:
I. Evaluate plasma hPG80 as a biomarker of treatment response. II. Evaluate plasma deoxyribonucleosides as a biomarker of triapine resistance. III. Collect plasma for circulating deoxyribonucleic acid (DNA) (ctDNA) assessment.
IV. Evaluate triapine plasma pharmacokinetics (PK) in the combination arm (treatment arm 1 only).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive triapine orally (PO) on days 1-14 of each cycle and lutetium Lu 177 dotatate intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.
ARM 2: Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 8 and 12 months, then every 6 months for 2 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Principal Investigator:
- Daneng Li
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 916-734-3089
-
Principal Investigator:
- Edward J. Kim
-
-
Florida
-
Aventura, Florida, United States, 33180
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Aventura
-
Contact:
- Site Public Contact
- Phone Number: 954-461-2180
-
Principal Investigator:
- Aman Chauhan
-
Coral Gables, Florida, United States, 33146
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Coral Gables
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Aman Chauhan
-
Deerfield Beach, Florida, United States, 33442
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Aman Chauhan
-
Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida Health Science Center - Gainesville
-
Contact:
- Site Public Contact
- Phone Number: 352-273-8010
- Email: cancer-center@ufl.edu
-
Principal Investigator:
- Kathryn E. Hitchcock
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Aman Chauhan
-
Miami, Florida, United States, 33176
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Kendall
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Aman Chauhan
-
Plantation, Florida, United States, 33324
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Plantation
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Aman Chauhan
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Principal Investigator:
- Al B. Benson
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky/Markey Cancer Center
-
Principal Investigator:
- Lowell B. Anthony
-
Contact:
- Site Public Contact
- Phone Number: 859-257-3379
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Principal Investigator:
- Matthew P. Deek
-
Contact:
- Site Public Contact
- Phone Number: 732-235-7356
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- NYP/Weill Cornell Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 212-746-1848
-
Principal Investigator:
- Elizabeta C. Popa
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-293-5066
- Email: Jamesline@osumc.edu
-
Principal Investigator:
- Bhavana Konda
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center LAO
-
Principal Investigator:
- Lowell B. Anthony
-
Contact:
- Lowell B. Anthony
- Email: lowell.anthony@uky.edu
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Cancer Institute (UPCI)
-
Contact:
- Site Public Contact
- Phone Number: 412-647-8073
-
Principal Investigator:
- Janie Y. Zhang
-
-
Texas
-
Conroe, Texas, United States, 77384
- Recruiting
- MD Anderson in The Woodlands
-
Contact:
- Site Public Contact
- Phone Number: 866-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Daniel M. Halperin
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Daniel M. Halperin
-
Houston, Texas, United States, 77079
- Recruiting
- MD Anderson West Houston
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Daniel M. Halperin
-
League City, Texas, United States, 77573
- Recruiting
- MD Anderson League City
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Daniel M. Halperin
-
Sugar Land, Texas, United States, 77478
- Recruiting
- MD Anderson in Sugar Land
-
Contact:
- Site Public Contact
- Phone Number: 877-632-6789
- Email: askmdanderson@mdanderson.org
-
Principal Investigator:
- Daniel M. Halperin
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Heloisa P. Soares
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin Carbone Cancer Center
-
Principal Investigator:
- Sam J. Lubner
-
Contact:
- Site Public Contact
- Phone Number: 800-622-8922
- Email: clinicaltrials@cancer.wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must have metastatic, histologically confirmed well-differentiated neuroendocrine tumor with positive gallium 68 DOTATATE or copper 64 DOTATATE scan. Lesions on dotatate scan will be considered positive if the standardized uptake volume maximum (SUVmax) of target lesion is > 2 times standardized uptake value (SUV) mean of normal liver parenchyma. Patients with lung neuroendocrine tumors (NETs) are excluded from the trial
- Patients must have progressive disease based on RECIST criteria, version 1.1 evidenced with CT scans/MRI obtained within 24 months from enrollment
- Patients must have measurable disease per RECIST 1.1
- Failure of at least one prior systemic cancer treatment with somatostatin analogs
- No prior exposure to peptide receptor radionuclide therapy
- Recovered from adverse events of previously administered therapeutic agents (i.e., to grade 2 or less toxicity) according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Age >= 18 years
- Because no dosing or adverse event data are currently available on the use of triapine in combination with lutetium Lu 177 dotatate in patients < 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- Serum creatinine =< 1.5 x institutional ULN. Creatinine > 1.5 ULN will require a measured creatinine clearance (CrCl) > 50 ml/min to qualify
- Hemoglobin > 5.0 mmol/L (> 8.0 g/dL)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases and off steroids are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to enrollment in the study
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Pregnancy precaution: Men and women should avoid pregnancy for seven months after the date of their last treatment with lutetium Lu 177 dotatate. It is noteworthy that beta-human chorionic gonadotropin (beta-HCG) may be secreted by a small percentage of NETs, such that, in addition to being a pregnancy marker, it also is a tumor marker. Consequently, NET female patients with positive beta-HCG (> 5 mIU/mL) at baseline can be eligible to enter the study and receive treatment if pregnancy can be excluded by lack of expected doubling of beta-HCG and negative pelvic ultrasound. Normally, in pregnant subjects beta-HCG doubles every 2 days during the first 4 weeks of pregnancy and every 3.5 days by weeks 6 to 7. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhea > 12 consecutive months, and for women on hormone replacement therapy, only with a documented plasma follicle-stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral, implanted, or injected contraceptive hormones, an intrauterine device (IUD), or barrier methods (diaphragm, condoms, spermicidal) to prevent pregnancy, are practicing abstinence or where the partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential. Postmenopausal women who have fertilized eggs implanted are also considered to be of childbearing potential. Acceptable methods of contraception may include total abstinence at the discretion of the Investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception (hormonal or barrier method of birth control; abstinence) should be maintained throughout the study and for 7 months after study treatment discontinuation. All men and women of childbearing potential and male partners must use a double-barrier method of birth control or practice continuous abstinence from heterosexual contact throughout the study and for seven months after the end of the last treatment
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have not recovered from adverse events of previously administered therapeutic agents (i.e., have residual toxicities > grade 2) according to CTCAE 5.0, with the exception of alopecia
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or lutetium Lu 177 dotatate
- Patients with uncontrolled intercurrent illness
- Uncontrolled congestive heart failure (New York Heart Association [NYHA] III, IV)
- Pregnant women are excluded from this study because triapine is a ribonucleotide reductase (RNR) inhibitor and lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine and lutetium Lu 177 dotatate, breastfeeding should be discontinued if the mother is treated with triapine and lutetium Lu 177 dotatate and for 2.5 months following the last treatment
- Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
- Patients with any other significant condition, currently uncontrolled by treatment, which may interfere with completion of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1 (triapine, lutetium Lu 177 dotatate)
Patients receive triapine PO on days 1-14 of each cycle and lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle.
Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
|
Undergo collection of blood samples
Other Names:
Undergo MRI
Other Names:
Undergo CT
Other Names:
Given IV
Other Names:
Given PO
Other Names:
|
Active Comparator: Arm 2 (lutetium Lu 177 dotatate)
Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle.
Cycles repeat every 8 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT and/or MRI and collection of blood samples throughout the trial.
|
Undergo collection of blood samples
Other Names:
Undergo MRI
Other Names:
Undergo CT
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to 5 years
|
Estimated along with exact 95% binomial confidence intervals in each arm and compared between arms using the z-test statistic.
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: Time from the date of randomization to the date of first documented progression or death due to any cause, assessed up to 5 years
|
Progression will be measured by Response Evaluation Criteria in Solid Tumors 1.1 criteria.
Log-rank test will be used to compare PFS between treatment and control.
Median survival time and the corresponding confidence intervals will be calculated by the Kaplan-Meier Method.
|
Time from the date of randomization to the date of first documented progression or death due to any cause, assessed up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma hPG80
Time Frame: Up to 5 years
|
Analysis of variance will be used to analyze plasma hPG80 concentration.
Baseline plasma hPG80 will be used as covariate.
F-test and t-test will be conducted to test the differences in hPG80 change between treatment arms and responses.
|
Up to 5 years
|
Plasma deoxyribonucleosides
Time Frame: Pre- to post-triapine administration
|
Will evaluate plasma deoxyribonucleosides as a biomarker of triapine resistance.
Pre and post triapine administration changes in deoxyribonucleosides will be analyzed by pair-wise t-test, stratified by study arm.
Secondary and exploratory analysis on repeatedly measured deoxyribonucleosides will entail a linear mixed model for comparison between treatment groups.
|
Pre- to post-triapine administration
|
Circulating deoxyribonucleic acid (ctDNA)
Time Frame: Up to 5 years
|
ctDNA will be analyzed by summary descriptive statistics as well as visualization graphics such as heat maps.
Data processing and downstream data analysis pipelines for the genomic data will be performed including differential analysis for comparison of genomic data between arms using the limma package in R/Bioconductor with adjustment for false discovery rate.
|
Up to 5 years
|
Triapine plasma pharmacokinetics (PK): Maximum concentration
Time Frame: Up to 5 years
|
Will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated.
PK parameters will be reported descriptively for exploratory comparison with historical data.
Smoking status will be a particular covariate to be evaluated as a determinant of PK.
Exploratory correlative studies with pharmacodynamics (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics.
Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
|
Up to 5 years
|
Triapine plasma PK: Area under the concentration-time curve
Time Frame: Up to 5 years
|
Will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated.
PK parameters will be reported descriptively for exploratory comparison with historical data.
Smoking status will be a particular covariate to be evaluated as a determinant of PK.
Exploratory correlative studies with pharmacodynamics (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics.
Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
|
Up to 5 years
|
Triapine plasma PK: Half-life
Time Frame: Up to 5 years
|
Will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated.
PK parameters will be reported descriptively for exploratory comparison with historical data.
Smoking status will be a particular covariate to be evaluated as a determinant of PK.
Exploratory correlative studies with pharmacodynamics (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics.
Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
|
Up to 5 years
|
Triapine plasma PK: Apparent clearance
Time Frame: Up to 5 years
|
Will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated.
PK parameters will be reported descriptively for exploratory comparison with historical data.
Smoking status will be a particular covariate to be evaluated as a determinant of PK.
Exploratory correlative studies with pharmacodynamics (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics.
Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
|
Up to 5 years
|
Triapine plasma PK: Apparent volume of distribution
Time Frame: Up to 5 years
|
Will be tabulated and descriptive statistics (e.g., geometric means and coefficients of variation) calculated.
PK parameters will be reported descriptively for exploratory comparison with historical data.
Smoking status will be a particular covariate to be evaluated as a determinant of PK.
Exploratory correlative studies with pharmacodynamics (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics.
Advanced population PK methods may be employed at a later stage to assess the link between drug exposure and biological effects and efficacy.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lowell B Anthony, Ohio State University Comprehensive Cancer Center LAO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2023-01224 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UM1CA186712 (U.S. NIH Grant/Contract)
- 10558 (Other Identifier: CTEP)
- NCI-CIRB-10558-PMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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