Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03994796
Collaborator
National Cancer Institute (NCI) (NIH), Genentech, Inc. (Industry)
150
387
3
69.6
0.4
0

Study Details

Study Description

Brief Summary

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, paxalisib, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the activity of a CDK inhibitor in patients with progressive brain metastases derived from lung cancer, breast cancer, and other cancers harboring actionable genetic alterations associated with sensitivity to CDK inhibitors as measured by response rate (Response Assessment in Neuro-Oncology [RANO] criteria).

  2. To determine the activity of a PI3K inhibitor in patients with progressive brain metastases derived from lung cancer, breast cancer, and other cancers harboring actionable genetic alterations in the PI3K pathway as measured by response rate (RANO criteria).

III: To determine the activity of an NTRK/ROS1 inhibitor in patients with progressive brain metastases derived from lung cancer harboring actionable NTRK/ROS1 gene fusions as measured by response rate (RANO criteria).

SECONDARY OBJECTIVES:
  1. To evaluate the systemic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each of the cohorts determined by treatment and primary cancer type.

  2. To evaluate the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD]) by Brain Metastases (BM)-RANO for central nervous system (CNS) in each of the cohorts determined by treatment and primary cancer type.

  3. To evaluate the clinical benefit rate (CR + PR + SD) by RECIST for extracranial disease in each of the cohorts determined by treatment and primary cancer type.

  4. To evaluate the duration of response by BM-RANO in each of the cohorts determined by treatment and primary cancer type.

  5. To evaluate the duration of response by RECIST in each of the cohorts determined by treatment and primary cancer type.

  6. To evaluate the progression-free survival for intracranial disease in each of the cohorts determined by treatment and primary cancer type.

  7. To evaluate the progression-free survival for extracranial disease in each of the cohorts determined by treatment and primary cancer type.

  8. To evaluate the site of first progression (CNS versus [vs] non-CNS) in each of the cohorts determined by treatment and primary cancer type.

  9. To evaluate the overall survival in each of the cohorts determined by treatment and primary cancer type.

  10. To evaluate the toxicity profile of agents in patients with brain metastases in each of the cohorts determined by treatment and primary cancer type.

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM I (CDK GENE MUTATION): Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (PI3K GENE MUTATION): Patients receive PI3K inhibitor paxalisib PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III (NTRK/ROS1 GENE MUTATION): Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 8 weeks for 2 years, then every 3 months for years 3-4, and then every 6 months thereafter for up to 5 years after registration.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Genomically-Guided Treatment Trial in Brain Metastases
Actual Study Start Date :
Aug 15, 2019
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (CDK gene mutation)

Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Abemaciclib
Given PO

Experimental: Arm II (PI3K gene mutation)

Patients receive PI3K inhibitor paxalisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: PI3K Inhibitor paxalisib
Given PO

Experimental: Arm III (NTRK/ROS1 gene mutation)

Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Entrectinib
Given PO

Outcome Measures

Primary Outcome Measures

  1. Objective response rate in the brain [Up to 5 years]

    Assessed per Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases. The response rate is defined as the number of patients who have achieved complete response (CR) or partial response (PR) per RANO for brain metastases criteria during treatment with CDK, PI3K, or NTRK/ROS inhibitors divided by total number of evaluable patients. The response rate and associated exact confidence interval will be estimated within each cohort defined by the targeted agent and histology.

Secondary Outcome Measures

  1. Systemic response for extracranial disease [Up to 5 years]

    Assessed with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be estimated using the systemic response rate (SRR) - where SRR is defined as the number of evaluable patients achieving a response (PR or CR per RECIST 1.1) during treatment with study therapy divided by the total number of evaluable patients. Point estimates will be generated for systemic response rates within each cohort with corresponding 95% binomial confidence intervals.

  2. Clinical benefit rate for central nervous system (CNS) [Up to 5 years]

    Evaluated by Response Assessment in Neuro-Oncology (RANO) criteria. Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

  3. Clinical benefit rate for extracranial disease [Up to 5 years]

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Will be estimated as the number of evaluable patients achieving stable disease (SD), partial response (PR), or complete response (CR) as their best objective response (per RECIST for extracranial disease) during treatment with protocol therapy divided by the total number of evaluable patients. Point estimates will be generated for clinical benefit rates within each cohort with corresponding 95% binomial confidence intervals.

  4. Duration of response for brain metastases [From the time measurement criteria are met for CR or PR for brain metastases until the first date that progressive CNS disease or death is documented, assessed up to 5 years]

    Duration of response for brain metastases is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for brain metastases is first noted to be a CR or PR (per Response Assessment in Neuro-Oncology [RANO] for brain metastases) to the date of the earliest progressive CNS disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

  5. Duration of response for extracranial disease [From the time measurement criteria are met for CR or PR for extracranial disease until the first date that progressive disease for extracranial disease or death is documented, assessed up to 5 years]

    Duration of response for extracranial disease is defined for all evaluable patients who have achieved a confirmed response as the time from the date at which the patient's objective status for extranial disease is first noted to be a CR or PR (per RECIST1.1) to the date of the earliest progression (PD) for extracranial disease is documented or death. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

  6. Progression-free survival (PFS) - intracranial [From first day of study treatment to the earliest date documentation of intracranial disease progression or death from any cause, assessed up to 5 years]

    Intracranial PFS is defined as the time from the first day of study treatment to the earliest date of intracranial disease progression (per RANO for brain metastases) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

  7. Progression-free survival (PFS) - extracranial [From the first day of study treatment to the earliest date of documentation of extracranial disease progression or death from any cause, assessed up to 5 years]

    Extracranial PFS is defined as the time from the first day of study treatment to the earliest date of extracranial disease progression (per RECIST1.1) or death from any cause, whichever comes first. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

  8. Site of first progression [Up to 24 months]

    The site of first progression will be estimated descriptively within each cohort within 12 and 24 months after starting protocol treatment. The first progression is defined as the first documented central nervous system (CNS) progression per Response Assessment in Neuro-Oncology (RANO) or extracranial progression per Response Evaluation Criteria in Solid Tumors (RECIST), whichever occurs first. The percentage of extracranial progression at first progression within 12 and 24 months after starting protocol treatment will be estimated as number of patients who experience the first progression which is extracranial progression divided by number of patients who are still at risk up to 12 and 24 months, respectively.

  9. Overall survival [From the first day of study treatment to death due to any cause, assessed up to 5 years]

    Overall survival is defined as the time from the first day of study treatment to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. No formal comparison will be made among the cohorts.

  10. Incidence of adverse events [Up to 5 years]

    Assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by patient and treatment cohort will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of the analysis. No formal comparison will be made among the cohorts.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS) • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).

REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Participants must have histologically confirmed parenchymal metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease.

  • New or progressive brain metastases are defined as any one of the following:

  • Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions.

  • Progressive measurable lesions after radiation, surgery, or prior systemic therapy

  • Residual or progressive lesions after surgery if asymptomatic.

  • Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression. For patients with NTRK or ROS1 mutations, entrectinib may be used for newly diagnosed brain metastases.

  • Patients who have not previously been treated with cranial radiation (e.g. WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases.

  • Measurable CNS disease (=> 10 mm).

  • Ability to obtain magnetic resonance imaging (MRI)s with contrast

  • No surgery within 2 weeks prior to or after registration.

  • No chemotherapy within 14 days prior to registration (Note: for abemaciclib arm, a 21-day chemotherapy washout is required).

  • For melanoma, patients must have progressed after prior immune checkpoint blockade or for BRAF positive melanoma, BRAF/MEK inhibitors.

  • For lung cancer, EGFR mutant patients must have failed EGFR therapies

  • For HER2-positive breast cancer patients (regardless of ER/PR status), patients must have received at least one prior HER-2 directed therapy in the metastatic setting.

  • For triple negative breast cancer (TNBC), patients must have received at least one chemotherapy in the metastatic setting.

  • For estrogen receptor (ER) and/or progesterone receptor (PR)+ HER2-negative breast cancer, patients must have received at least one endocrine therapy in the metastatic setting.

  • Patients who have received prior treatment with any of the targeted treatments on this study are not eligible for that specific treatment arm(s), but could be eligible for other arms (e.g., a patient who has had prior treatment with abemaciclib would not be eligible for the abemaciclib arm, but could be eligible for another arm).

  • Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site per central review.

  • Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required (Note: for abemaciclib arm, pregnancy test is required =< 7 days prior to registration).

  • No known current diffuse leptomeningeal involvement (diffuse defined as leptomeningeal involvement throughout the CNS axis; if there is documented positive CSF cytology, patient is ineligible).

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

  • Adequate organ function.

  • Absolute neutrophil count (ANC) >= 1,500/mm^3.

  • Platelet count >= 100,000/mm^3.

  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert's disease. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN).

  • Creatinine =< 1.5 mg/dL OR calculated (Calc.) creatinine clearance > 45 mL/min.

  • No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)

  • Radiation to symptomatic non-target sites within neural axis is allowed prior to registration without washout (provided there is at least one untreated target lesion for measurement on study and radiation is completed prior to registration).

  • Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration. Baseline doses and changes in steroid dosing will be captured.

  • No concurrent administration of anticancer therapies (except for endocrine therapy or continuation of hormonal therapy or trastuzumab in breast cancer patients). No chemotherapy, targeted therapy or immunotherapy within 14 days prior to entering the study (Note: For abemaciclib arm, a 21-day chemotherapy washout is required).

  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to registration on the study.

  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR PAXALISIB ARM

  • Urine protein to creatinine (UPC) ratio < 1 or urine protein =< 1.

  • Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded. Patients with symptomatic bradycardia should have an electrocardiogram at baseline. If QT interval > 470 msec, the patient is excluded.

  • Patients with uncontrolled type I or II diabetes mellitus should be excluded. Uncontrolled diabetes is defined as glycosylated hemoglobin (HbA1c) > 9% in addition to fasting glucose > 140 mg/dL on at least 2 occasions within 14 days prior to registration.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERION FOR ENTRECTINIB ARM

• Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERION FOR ABEMACICLIB ARM

  • Hemoglobin >= g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.

  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to registration. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy).

  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.

  • Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4/6 pathway alteration on a biopsy or resection at the point of progression post-ribociclib or palbociclib.

  • For females of childbearing potential: A female of childbearing potential, must have a negative serum pregnancy test within 7 days prior to registration and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation.

  • Patients with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive] are excluded. Screening is not required for enrollment.

  • Patients with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, are excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
6 Anchorage Oncology Centre Anchorage Alaska United States 99508
7 Katmai Oncology Group Anchorage Alaska United States 99508
8 Providence Alaska Medical Center Anchorage Alaska United States 99508
9 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
10 Mayo Clinic Hospital in Arizona Phoenix Arizona United States 85054
11 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
12 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
13 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
14 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
15 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
16 Epic Care-Dublin Dublin California United States 94568
17 Bay Area Breast Surgeons Inc Emeryville California United States 94608
18 Epic Care Partners in Cancer Care Emeryville California United States 94608
19 UC San Diego Moores Cancer Center La Jolla California United States 92093
20 Cedars Sinai Medical Center Los Angeles California United States 90048
21 Contra Costa Regional Medical Center Martinez California United States 94553-3156
22 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
23 Bay Area Tumor Institute Oakland California United States 94609
24 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
25 Sharp Memorial Hospital San Diego California United States 92123
26 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
27 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
28 Torrance Memorial Physician Network - Cancer Care Torrance California United States 90505
29 Torrance Memorial Medical Center Torrance California United States 90509
30 Epic Care Cyberknife Center Walnut Creek California United States 94597
31 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
32 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
33 Porter Adventist Hospital Denver Colorado United States 80210
34 Mercy Medical Center Durango Colorado United States 81301
35 Southwest Oncology PC Durango Colorado United States 81301
36 Saint Anthony Hospital Lakewood Colorado United States 80228
37 Littleton Adventist Hospital Littleton Colorado United States 80122
38 Longmont United Hospital Longmont Colorado United States 80501
39 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
40 Parker Adventist Hospital Parker Colorado United States 80138
41 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
42 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
43 Yale University New Haven Connecticut United States 06520
44 Boca Raton Regional Hospital Boca Raton Florida United States 33486
45 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
46 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
47 Holy Cross Hospital Fort Lauderdale Florida United States 33308
48 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
49 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
50 Emory University Hospital Midtown Atlanta Georgia United States 30308
51 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
52 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
53 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
54 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
55 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
56 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
57 Walter Knox Memorial Hospital Emmett Idaho United States 83617
58 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
59 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
60 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
61 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
62 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
63 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
64 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
65 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
66 Saint Anthony's Health Alton Illinois United States 62002
67 Rush - Copley Medical Center Aurora Illinois United States 60504
68 Northwestern University Chicago Illinois United States 60611
69 Rush University Medical Center Chicago Illinois United States 60612
70 University of Illinois Chicago Illinois United States 60612
71 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
72 Carle on Vermilion Danville Illinois United States 61832
73 Carle Physician Group-Effingham Effingham Illinois United States 62401
74 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
75 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
76 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
77 Carle Cancer Center Urbana Illinois United States 61801
78 The Carle Foundation Hospital Urbana Illinois United States 61801
79 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
80 Mary Greeley Medical Center Ames Iowa United States 50010
81 McFarland Clinic PC - Ames Ames Iowa United States 50010
82 McFarland Clinic PC-Boone Boone Iowa United States 50036
83 Saint Anthony Regional Hospital Carroll Iowa United States 51401
84 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
85 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
86 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
87 Greater Regional Medical Center Creston Iowa United States 50801
88 Iowa Methodist Medical Center Des Moines Iowa United States 50309
89 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
90 Broadlawns Medical Center Des Moines Iowa United States 50314
91 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
92 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
93 Iowa Lutheran Hospital Des Moines Iowa United States 50316
94 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
95 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
96 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
97 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
98 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
99 Methodist West Hospital West Des Moines Iowa United States 50266-7700
100 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
101 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
102 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
103 HaysMed University of Kansas Health System Hays Kansas United States 67601
104 University of Kansas Cancer Center Kansas City Kansas United States 66160
105 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
106 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
107 Flaget Memorial Hospital Bardstown Kentucky United States 40004
108 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
109 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
110 Saint Joseph Hospital East Lexington Kentucky United States 40509
111 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
112 Saint Joseph London London Kentucky United States 40741
113 Jewish Hospital Louisville Kentucky United States 40202
114 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
115 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
116 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
117 Ochsner LSU Health Monroe Medical Center Monroe Louisiana United States 71202
118 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
119 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
120 University Medical Center New Orleans New Orleans Louisiana United States 70112
121 Ochsner LSU Health Saint Mary's Medical Center Shreveport Louisiana United States 71101
122 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
123 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
124 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
125 Mercy Medical Center Springfield Massachusetts United States 01104
126 Hickman Cancer Center Adrian Michigan United States 49221
127 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
128 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
129 Bronson Battle Creek Battle Creek Michigan United States 49017
130 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
131 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
132 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
133 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
134 Saint Joseph Mercy Canton Canton Michigan United States 48188
135 Caro Cancer Center Caro Michigan United States 48723
136 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
137 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
138 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
139 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
140 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
141 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
142 Henry Ford Hospital Detroit Michigan United States 48202
143 Ascension Saint John Hospital Detroit Michigan United States 48236
144 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
145 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
146 Genesee Hematology Oncology PC Flint Michigan United States 48503
147 Genesys Hurley Cancer Institute Flint Michigan United States 48503
148 Hurley Medical Center Flint Michigan United States 48503
149 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
150 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
151 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
152 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
153 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
154 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
155 Allegiance Health Jackson Michigan United States 49201
156 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
157 West Michigan Cancer Center Kalamazoo Michigan United States 49007
158 Ascension Borgess Cancer Center Kalamazoo Michigan United States 49009
159 Borgess Medical Center Kalamazoo Michigan United States 49048
160 Sparrow Hospital Lansing Michigan United States 48912
161 Hope Cancer Clinic Livonia Michigan United States 48154
162 Saint Mary Mercy Hospital Livonia Michigan United States 48154
163 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
164 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
165 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
166 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
167 Mercy Health Mercy Campus Muskegon Michigan United States 49444
168 Lakeland Hospital Niles Niles Michigan United States 49120
169 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
170 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
171 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
172 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
173 Hope Cancer Center Pontiac Michigan United States 48341
174 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
175 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
176 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
177 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
178 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
179 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
180 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
181 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
182 Henry Ford Macomb Health Center - Shelby Township Shelby Michigan United States 48315
183 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
184 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
185 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
186 Munson Medical Center Traverse City Michigan United States 49684
187 Advanced Breast Care Center PLLC Warren Michigan United States 48088
188 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
189 Macomb Hematology Oncology PC Warren Michigan United States 48093
190 Michigan Breast Specialists-Warren Warren Michigan United States 48093
191 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
192 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
193 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
194 Metro Health Hospital Wyoming Michigan United States 49519
195 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
196 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
197 Fairview Ridges Hospital Burnsville Minnesota United States 55337
198 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
199 Cambridge Medical Center Cambridge Minnesota United States 55008
200 Mercy Hospital Coon Rapids Minnesota United States 55433
201 Fairview Southdale Hospital Edina Minnesota United States 55435
202 Unity Hospital Fridley Minnesota United States 55432
203 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
204 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
205 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
206 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
207 Hennepin County Medical Center Minneapolis Minnesota United States 55415
208 Health Partners Inc Minneapolis Minnesota United States 55454
209 Monticello Cancer Center Monticello Minnesota United States 55362
210 New Ulm Medical Center New Ulm Minnesota United States 56073
211 Fairview Northland Medical Center Princeton Minnesota United States 55371
212 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
213 Mayo Clinic in Rochester Rochester Minnesota United States 55905
214 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
215 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
216 Regions Hospital Saint Paul Minnesota United States 55101
217 United Hospital Saint Paul Minnesota United States 55102
218 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
219 Lakeview Hospital Stillwater Minnesota United States 55082
220 Ridgeview Medical Center Waconia Minnesota United States 55387
221 Rice Memorial Hospital Willmar Minnesota United States 56201
222 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
223 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
224 University of Mississippi Medical Center Jackson Mississippi United States 39216
225 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
226 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
227 Cox Cancer Center Branson Branson Missouri United States 65616
228 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
229 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
230 Freeman Health System Joplin Missouri United States 64804
231 Mercy Hospital Joplin Joplin Missouri United States 64804
232 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
233 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
234 University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri United States 64116
235 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
236 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
237 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
238 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
239 Washington University School of Medicine Saint Louis Missouri United States 63110
240 Mercy Hospital South Saint Louis Missouri United States 63128
241 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
242 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
243 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
244 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
245 Mercy Hospital Springfield Springfield Missouri United States 65804
246 CoxHealth South Hospital Springfield Missouri United States 65807
247 Mercy Hospital Washington Washington Missouri United States 63090
248 Community Hospital of Anaconda Anaconda Montana United States 59711
249 Billings Clinic Cancer Center Billings Montana United States 59101
250 Bozeman Deaconess Hospital Bozeman Montana United States 59715
251 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
252 Great Falls Clinic Great Falls Montana United States 59405
253 Kalispell Regional Medical Center Kalispell Montana United States 59901
254 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
255 Community Medical Hospital Missoula Montana United States 59804
256 CHI Health Saint Francis Grand Island Nebraska United States 68803
257 CHI Health Good Samaritan Kearney Nebraska United States 68847
258 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
259 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
260 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
261 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
262 Creighton University Medical Center Omaha Nebraska United States 68131
263 Midlands Community Hospital Papillion Nebraska United States 68046
264 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
265 Morristown Medical Center Morristown New Jersey United States 07960
266 Capital Health Medical Center-Hopewell Pennington New Jersey United States 08534
267 Overlook Hospital Summit New Jersey United States 07902
268 Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico United States 87102
269 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
270 Lovelace Radiation Oncology Albuquerque New Mexico United States 87109
271 New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York United States 11215
272 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
273 Glens Falls Hospital Glens Falls New York United States 12801
274 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
275 NYP/Weill Cornell Medical Center New York New York United States 10065
276 Upstate Cancer Center at Oneida Oneida New York United States 13421
277 University of Rochester Rochester New York United States 14642
278 State University of New York Upstate Medical University Syracuse New York United States 13210
279 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
280 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
281 Atrium Health Pineville/LCI-Pineville Charlotte North Carolina United States 28210
282 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
283 Duke University Medical Center Durham North Carolina United States 27710
284 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
285 Vidant Oncology-Kenansville Kenansville North Carolina United States 28349
286 Vidant Oncology-Kinston Kinston North Carolina United States 28501
287 Vidant Oncology-Richlands Richlands North Carolina United States 28574
288 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
289 Geauga Hospital Chardon Ohio United States 44024
290 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
291 Bethesda North Hospital Cincinnati Ohio United States 45242
292 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
293 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
294 Case Western Reserve University Cleveland Ohio United States 44106
295 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
296 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
297 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
298 University Hospitals Parma Medical Center Parma Ohio United States 44129
299 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
300 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
301 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
302 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
303 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
304 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
305 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
306 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
307 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
308 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
309 Saint Charles Health System Bend Oregon United States 97701
310 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
311 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
312 Bay Area Hospital Coos Bay Oregon United States 97420
313 Providence Newberg Medical Center Newberg Oregon United States 97132
314 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
315 Providence Portland Medical Center Portland Oregon United States 97213
316 Providence Saint Vincent Medical Center Portland Oregon United States 97225
317 Saint Charles Health System-Redmond Redmond Oregon United States 97756
318 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
319 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
320 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
321 Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania United States 18201
322 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
323 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
324 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
325 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
326 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
327 Parkland Memorial Hospital Dallas Texas United States 75235
328 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
329 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
330 M D Anderson Cancer Center Houston Texas United States 77030
331 Memorial Hermann Texas Medical Center Houston Texas United States 77030
332 Memorial Hermann Northeast Hospital Humble Texas United States 77338
333 Memorial Hermann The Woodlands Hospital The Woodlands Texas United States 77380
334 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
335 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
336 University of Vermont Medical Center Burlington Vermont United States 05401
337 University of Vermont and State Agricultural College Burlington Vermont United States 05405
338 Inova Schar Cancer Institute Fairfax Virginia United States 22031
339 Inova Fair Oaks Hospital Fairfax Virginia United States 22033
340 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
341 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
342 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
343 Harrison Medical Center Bremerton Washington United States 98310
344 Highline Medical Center-Main Campus Burien Washington United States 98166
345 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
346 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
347 Saint Elizabeth Hospital Enumclaw Washington United States 98022
348 Providence Regional Cancer Partnership Everett Washington United States 98201
349 Saint Francis Hospital Federal Way Washington United States 98003
350 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
351 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
352 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
353 Saint Clare Hospital Lakewood Washington United States 98499
354 PeaceHealth Saint John Medical Center Longview Washington United States 98632
355 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
356 Pacific Gynecology Specialists Seattle Washington United States 98104
357 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
358 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
359 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
360 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
361 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
362 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
363 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
364 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
365 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
366 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
367 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
368 Aurora Saint Luke's South Shore Cudahy Wisconsin United States 53110
369 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
370 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
371 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
372 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
373 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
374 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
375 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
376 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
377 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
378 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
379 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
380 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
381 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
382 Aurora Medical Center in Summit Summit Wisconsin United States 53066
383 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
384 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
385 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
386 Billings Clinic-Cody Cody Wyoming United States 82414
387 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)
  • Genentech, Inc.

Investigators

  • Study Chair: Priscilla Brastianos, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT03994796
Other Study ID Numbers:
  • A071701
  • NCI-2019-00744
  • U10CA180821
First Posted:
Jun 21, 2019
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022