CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer
NCT ID: NCT05685602
Last Updated: 2025-12-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-12
Study Completion Date
2026-04-30
Brief Summary
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This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). CA-4948 is in a class of medications called kinase inhibitors. It works by blocking the action of abnormal proteins called interleukin-1 receptor-associated kinase 4 (IRAK4) and FMS-like tyrosine kinase 3 (FLT3) that signal cells to multiply. This may help keep cancer cells from growing. The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.
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Detailed Description
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PRIMARY OBJECTIVE:
I. To assess dose limiting toxicities and determine the recommended phase 2 dose of emavusertib (CA--4948) in combination with chemotherapy in patients with pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To evaluate the safety and tolerability of the combination of CA-4948 and chemotherapy.
III. To determine preliminary signals of efficacy, as measured by objective response rate (ORR), CA-4948 response, progression free survival (PFS), and overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To evaluate pharmacodynamic effect of CA-4948 in combination with chemotherapy.
II. To evaluate pharmacokinetics of CA-4948 in combination with chemotherapy. III. To explore biomarkers and genomic alterations associated with treatment response.
OUTLINE: This is a dose-escalation study of CA-4948 in combination with fixed-dose gemcitabine and nab-paclitaxel followed by a dose-expansion study.
Patients receive CA-4948 orally (PO), gemcitabine intravenously (IV), and nab-paclitaxel IV on study. Patients undergo magnetic resonance imaging (MRI), computed tomography (CT) scan, positron emission tomography (PET) scan, and/or x-ray imaging throughout the trial. Patients also undergo tumor biopsies and blood sample collection during screening and on study.
I. To assess dose limiting toxicities and determine the recommended phase 2 dose of emavusertib (CA--4948) in combination with chemotherapy in patients with pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To evaluate the safety and tolerability of the combination of CA-4948 and chemotherapy.
III. To determine preliminary signals of efficacy, as measured by objective response rate (ORR), CA-4948 response, progression free survival (PFS), and overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To evaluate pharmacodynamic effect of CA-4948 in combination with chemotherapy.
II. To evaluate pharmacokinetics of CA-4948 in combination with chemotherapy. III. To explore biomarkers and genomic alterations associated with treatment response.
OUTLINE: This is a dose-escalation study of CA-4948 in combination with fixed-dose gemcitabine and nab-paclitaxel followed by a dose-expansion study.
Patients receive CA-4948 orally (PO), gemcitabine intravenously (IV), and nab-paclitaxel IV on study. Patients undergo magnetic resonance imaging (MRI), computed tomography (CT) scan, positron emission tomography (PET) scan, and/or x-ray imaging throughout the trial. Patients also undergo tumor biopsies and blood sample collection during screening and on study.
Conditions
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Metastatic Pancreatic Ductal Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Unresectable Pancreatic Ductal Adenocarcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (CA-4948, gemcitabine, nab-paclitaxel)
Patients receive CA-4948 orally (PO), gemcitabine intravenously (IV), and nab-paclitaxel IV on study. Patients undergo magnetic resonance imaging (MRI), computed tomography (CT) scan, positron emission tomography (PET) scan, and/or x-ray imaging throughout the trial. Patients also undergo tumor biopsies and blood sample collection during screening and on study.
Group Type
EXPERIMENTAL
Biopsy Procedure
Intervention Type
PROCEDURE
Undergo a tumor biopsy
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo blood sample collection
Computed Tomography
Intervention Type
PROCEDURE
Undergo a CT scan
Emavusertib
Intervention Type
BIOLOGICAL
Given PO
Gemcitabine Hydrochloride
Intervention Type
DRUG
Given IV
Magnetic Resonance Imaging
Intervention Type
PROCEDURE
Undergo MRI
Nab-paclitaxel
Intervention Type
DRUG
Given IV
Positron Emission Tomography
Intervention Type
PROCEDURE
Undergo a PET scan
X-Ray Imaging
Intervention Type
PROCEDURE
Undergo an x-ray
Interventions
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Biopsy Procedure
Undergo a tumor biopsy
Intervention Type
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
Intervention Type
PROCEDURE
Computed Tomography
Undergo a CT scan
Intervention Type
PROCEDURE
Emavusertib
Given PO
Intervention Type
BIOLOGICAL
Gemcitabine Hydrochloride
Given IV
Intervention Type
DRUG
Magnetic Resonance Imaging
Undergo MRI
Intervention Type
PROCEDURE
Nab-paclitaxel
Given IV
Intervention Type
DRUG
Positron Emission Tomography
Undergo a PET scan
Intervention Type
PROCEDURE
X-Ray Imaging
Undergo an x-ray
Intervention Type
PROCEDURE
Other Intervention Names
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Biopsy
BIOPSY_TYPE
Bx
Biological Sample Collection
Biospecimen Collected
Specimen Collection
CAT
CAT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized axial tomography (procedure)
Computerized Tomography
Computerized Tomography (CT) scan
CT
CT Scan
Diagnostic CAT Scan
Diagnostic CAT Scan Service Type
tomography
AU 4948
AU-4948
CA 4948
CA-4948
CA4948
Interleukin-1 Receptor-associated Kinase 4 Inhibitor CA-4948
IRAK4 Inhibitor CA-4948
dFdCyd
Difluorodeoxycytidine Hydrochloride
Gemcitabine HCI
Gemzar
LY 188011
LY-188011
LY188011
Magnetic Resonance
Magnetic Resonance Imaging (MRI)
Magnetic resonance imaging (procedure)
Magnetic Resonance Imaging Scan
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
MR
MR Imaging
MRI
MRI Scan
MRIs
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
sMRI
Structural MRI
ABI 007
ABI-007
ABI007
Abraxane
Albumin-bound Paclitaxel
Albumin-Stabilized Nanoparticle Paclitaxel
Nanoparticle Albumin-bound Paclitaxel
Nanoparticle Paclitaxel
Naveruclif
Paclitaxel Albumin
paclitaxel albumin-stabilized nanoparticle formulation
Paclitaxel Nanoparticle Albumin-bound
Paclitaxel Protein-Bound
Protein-bound Paclitaxel
Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron emission tomography (procedure)
Positron Emission Tomography Scan
Positron-Emission Tomography
PT
Conventional X-Ray
Diagnostic Radiology
Medical Imaging, X-Ray
Plain film radiographs
Radiographic Imaging
Radiographic imaging procedure (procedure)
Radiography
RG
Static X-Ray
X-Ray
Eligibility Criteria
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Inclusion Criteria
* Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Patients must have had disease progression on or after fluorouracil (5-FU)-based therapy for metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC). If received gemcitabine-based regimen as adjuvant therapy, then gemcitabine and nab-paclitaxel (if used) should be \>12 months from study enrollment. Prior use of gemcitabine/nab-paclitaxel for metastatic or unresectable disease is not allowed
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of CA-4948 in combination with gemcitabine and nab-paclitaxel 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
* Glomerular filtration rate (GFR) \>= 60 mL/min (based on the calculated Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] glomerular filtration rate estimation)
* Creatine phosphokinase (CPK) elevation at the screening \< grade 2 (creatine phosphokinase \[CPK\] =\< 2.5 ULN)
* Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as their anti-retroviral therapy does not have the potential for drug-drug interactions as judged by the treating investigator
* 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 are eligible if follow-up brain imaging after at least 4 weeks following central nervous system (CNS)-directed therapy shows no evidence of progression
* 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
* Patients must have lesions amenable to research biopsy for those enrolling to the expansion cohort. The biopsy should be deemed feasible and safe for pre-biopsy lesion assessment criteria
* The effects of CA-4948, nab-paclitaxel, and gemcitabine on the developing human fetus are unknown. For this reason and because gemcitabine is known to be teratogenic, embryotoxic, and fetotoxic in mice and rabbits, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of CA-4948, nab-paclitaxel, and gemcitabine administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of CA-4948, nab-paclitaxel, and gemcitabine administration
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible
* Patients must have had disease progression on or after fluorouracil (5-FU)-based therapy for metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC). If received gemcitabine-based regimen as adjuvant therapy, then gemcitabine and nab-paclitaxel (if used) should be \>12 months from study enrollment. Prior use of gemcitabine/nab-paclitaxel for metastatic or unresectable disease is not allowed
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of CA-4948 in combination with gemcitabine and nab-paclitaxel 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
* Glomerular filtration rate (GFR) \>= 60 mL/min (based on the calculated Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] glomerular filtration rate estimation)
* Creatine phosphokinase (CPK) elevation at the screening \< grade 2 (creatine phosphokinase \[CPK\] =\< 2.5 ULN)
* Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as their anti-retroviral therapy does not have the potential for drug-drug interactions as judged by the treating investigator
* 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 are eligible if follow-up brain imaging after at least 4 weeks following central nervous system (CNS)-directed therapy shows no evidence of progression
* 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
* Patients must have lesions amenable to research biopsy for those enrolling to the expansion cohort. The biopsy should be deemed feasible and safe for pre-biopsy lesion assessment criteria
* The effects of CA-4948, nab-paclitaxel, and gemcitabine on the developing human fetus are unknown. For this reason and because gemcitabine is known to be teratogenic, embryotoxic, and fetotoxic in mice and rabbits, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of CA-4948, nab-paclitaxel, and gemcitabine administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of CA-4948, nab-paclitaxel, and gemcitabine administration
* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion Criteria
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* Patients who have not recovered from clinically significant adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* History of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of disease under treatment
* History of allogeneic organ or stem cell transplant
* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment
* Patients who are receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948 or other agents used in study
* Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible due to CA-4948 and nab-paclitaxel. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Patients with uncontrolled intercurrent illness
* Pregnant women are excluded from this study because gemcitabine is nucleoside analogue 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 gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study
* Prolonged Fridericia's correction formula (QTcF) (\> 470 in females, \> 450 in males) on screening electrocardiogram (ECG)
* Gastrointestinal condition which could impair absorption of CA-4948 or inability to ingest CA-4948
* Severe obstructive pulmonary disease or interstitial lung disease
* History of rhabdomyolysis or elevated creatine phosphokinase (CPK)
* Patients who have not recovered from clinically significant adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
* History of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of disease under treatment
* History of allogeneic organ or stem cell transplant
* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment
* Patients who are receiving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948 or other agents used in study
* Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible due to CA-4948 and nab-paclitaxel. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
* Patients with uncontrolled intercurrent illness
* Pregnant women are excluded from this study because gemcitabine is nucleoside analogue 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 gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study
* Prolonged Fridericia's correction formula (QTcF) (\> 470 in females, \> 450 in males) on screening electrocardiogram (ECG)
* Gastrointestinal condition which could impair absorption of CA-4948 or inability to ingest CA-4948
* Severe obstructive pulmonary disease or interstitial lung disease
* History of rhabdomyolysis or elevated creatine phosphokinase (CPK)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Patrick Grierson
Role: PRINCIPAL_INVESTIGATOR
Yale University Cancer Center LAO
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Site Status
ACTIVE_NOT_RECRUITING
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Site Status
RECRUITING
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Site Status
RECRUITING
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Site Status
RECRUITING
Northwestern University
Chicago, Illinois, United States
Site Status
RECRUITING
Memorial Hospital East
Shiloh, Illinois, United States
Site Status
RECRUITING
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Site Status
RECRUITING
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Site Status
RECRUITING
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States
Site Status
RECRUITING
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Site Status
ACTIVE_NOT_RECRUITING
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Site Status
RECRUITING
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center-South County
St Louis, Missouri, United States
Site Status
RECRUITING
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Site Status
RECRUITING
NYU Langone Hospital - Long Island
Mineola, New York, United States
Site Status
RECRUITING
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Site Status
RECRUITING
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Site Status
RECRUITING
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Site Status
SUSPENDED
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Site Status
RECRUITING
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Site Status
RECRUITING
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Site Status
RECRUITING
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
RECRUITING
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Site Status
RECRUITING
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
Site Status
RECRUITING
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Site Status
RECRUITING
Countries
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United States
Facility Contacts
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Site Public Contact
Role: primary
720-848-0650
Site Public Contact
Role: primary
859-257-3379
Site Public Contact
Role: primary
800-411-1222
Site Public Contact
Role: primary
412-647-8073
Other Identifiers
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NCI-2022-08984
Identifier Type: -
Identifier Source: org_study_id
NCI-2022-08984
Identifier Type: REGISTRY
Identifier Source: secondary_id
10522
Identifier Type: OTHER
Identifier Source: secondary_id
10522
Identifier Type: OTHER
Identifier Source: secondary_id
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