Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors

NCT05247905 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: A022001NCI-2021-14404U10CA180821
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 171

Brief Summary

This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

Conditions

Metastatic Pancreatic Neuroendocrine Tumor; Unresectable Pancreatic Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival (PFS) will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio (HR) and median PFSwill be estimated along with corresponding 95% confidence intervals.

  Up to 8 years from randomization

Secondary Outcomes (10)

• Progression Free Survival (PFS) at 2 years

  At 2 years from randomization

• Progression Free Survival (PFS) at 3 years

  At 3 years from randomization

• Time to progression (TTP)

  Up to 8 years from randomization

• Overall survival (OS)

  Up to 8 years from study registration

• Objective response rate (ORR)

  Up to 8 years from randomization

Study Arms (2)

Arm I (lutetium Lu 177 dotatate)

EXPERIMENTAL

Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Lutetium Lu 177 Dotatate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (capecitabin, temozolomide)

EXPERIMENTAL

Patients receive capecitabine PO BID days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Capecitabine; Drug: Temozolomide; Other: Quality-of-Life Assessment

Interventions

Lutetium Lu 177 Dotatate DRUG

Given IV

Arm I (lutetium Lu 177 dotatate)

Capecitabine DRUG

Given PO

Arm II (capecitabin, temozolomide)

Temozolomide DRUG

Given PO

Arm II (capecitabin, temozolomide)

Quality-of-Life Assessment OTHER

Ancillary studies

Arm I (lutetium Lu 177 dotatate); Arm II (capecitabin, temozolomide)

Questionnaire Administration OTHER

Ancillary studies

Arm I (lutetium Lu 177 dotatate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or pathologic documentation: well-differentiated pancreatic neuroendocrine tumor (G1, G2, or well-differentiated G3) confirmed by local histology and/or pathology
• Functional or nonfunctional tumors are allowed
• Stage: locally unresectable or metastatic disease
• Tumor Site: neuroendocrine tumor of pancreatic primary site
• Radiologic evaluation: tumor must have shown somatostatin receptor (SSTR) positivity on 68Ga-DOTATATE PET or other SSTR-PET scan in the 12 months prior to registration; however, documentation of SSTR positivity in the 6 months prior to registration is preferred. SSTR positivity is defined as uptake greater than background liver in all measurable lesions
• Patients are eligible if they meet one of the following criteria:
• Previously untreated patients with grade 2 or 3 disease AND with symptoms of either disease bulk causing pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome). Patient may have been started on SSA for up to 2 months for attempted symptom control without disease progression prior to registration
• Patients previously treated with SSA only and with disease progression by RECIST in prior 12 months
• Patients previously treated with SSA and one or more prior systemic therapy must have received prior anti-vascular endothelial growth factor (VEGF) pathway therapy inhibitor OR have contraindication to anti-VEGF therapy (including but not limited to: uncontrolled hypertension \[systolic blood pressure \[SBP\] \> 150 and/or diastolic blood pressure \[DBP\] \> 90 despite medical management\], stage IIB or greater heart disease, angina pectoris, prior arterial \[ATE\] and venous thromboembolic \[VTE\] events in the past 6 months, gastrointestinal \[GI\] bleed in the last 6 months) and disease progression by RECIST in prior 12 months
• Patients previously treated with more than 2 lines of therapy, not including anti VEGF therapy, but with NET related symptoms as outlined in first bullet (pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, anorexia, early satiety, dyspnea) OR incompletely controlled symptoms of hormone excess despite somatostatin analogue (SSA) and supportive care (including but not limited to: diarrhea, hypercalcemia, hypoglycemia, hyperglycemia, flushing, Cushing's syndrome).
• Any patient with disease progression by RECIST criteria in \< 4 months
• Patients must have measurable disease per RECIST v1.1 by computer tomography (CT) scan or magnetic imaging (MRI). Any lesions which have undergone percutaneous therapies or radiotherapy after starting protocol therapy should not be considered measurable unless the lesion has clearly progressed since the procedure.
• \* Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or shortest diameter \>= 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non- measurable including: leptomeningeal disease, bone metastases, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.
• Prior treatment with tyrosine kinase inhibitors (TKIs) such as mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, temsirolimus, etc.) or VEGF pathway inhibitors (e.g. sunitinib, pazopanib, cabozantinib, bevacizumab, etc.) are allowed
• Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration

You may not qualify if:

• Patients with poorly differentiated neuroendocrine carcinoma (large cell histology or small cell histology) are not eligible
• No prior temozolomide, dacarbazine, capecitabine, 5-FU, or any PRRT for treatment of the pNET
• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects
• \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
• No known brain metastases unless adequately treated, demonstrated to be stable, and off all treatment (including steroids) for at least 2 months prior to registration
• No uncontrolled congestive heart failure (New York Heart Association \[NYHA\] II, III, IV).
• No significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to patient safety
• No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy or are on adjuvant hormonal therapy and are free of disease for \>= 3 years
• No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (171)

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Bay Area Breast Surgeons Inc

Emeryville, California, 94608, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505, United States

Location

Epic Care Cyberknife Center

Walnut Creek, California, 94597, United States

Location

BASS Medical Group - Lennon

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Foothills Hospital

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, 80112, United States

Location

The Women's Imaging Center

Denver, Colorado, 80209, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220, United States

Location

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, 80113, United States

Location

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, 80228, United States

Location

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120, United States

Location

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, 80260, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033, United States

Location

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

Location

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902, United States

Location

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Advocate Outpatient Center - Aurora

Aurora, Illinois, 60506, United States

Location

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

SIH Cancer Institute

Carterville, Illinois, 62918, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

Location

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

Location

Condell Memorial Hospital

Libertyville, Illinois, 60048, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

Location

Advocate Outpatient Center - Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

Location

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

Location

Mercy Health - Paducah Cancer Center

Paducah, Kentucky, 42003, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Hickman Cancer Center

Adrian, Michigan, 49221, United States

Location

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, 48162, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Sanford Cancer Center Worthington

Worthington, Minnesota, 56187, United States

Location

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

Location

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

Location

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

Location

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States

Location

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, 43537, United States

Location

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States

Location

Saint Vincent Hospital

Erie, Pennsylvania, 16544, United States

Location

Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025, United States

Location

Forbes Hospital

Monroeville, Pennsylvania, 15146, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, 15090, United States

Location

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, 02891, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Jefferson Healthcare

Port Townsend, Washington, 98368, United States

Location

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

Location

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729, United States

Location

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Aurora Health Center - Greenfield

Greenfield, Wisconsin, 53228, United States

Location

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

Location

Marshfield Medical Center - Ladysmith

Ladysmith, Wisconsin, 54848, United States

Location

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

Location

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States

Location

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

lutetium Lu 177 dotatate; Capecitabine; Temozolomide

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Timothy J. b, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: February 16, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): October 1, 2033
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

US (171)