ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:October 12, 2017
End Date:June 2020
Contact:Heather Horne
Email:hhorne@immunomedics.com
Phone:973-605-8200

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Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

This is an international, multi-center, open-label, randomized, Phase III study in patients
with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including
a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1
to receive either sacituzumab govitecan or treatment of physician choice (TPC) Patients will
be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever
comes first. Tumor progression leading to treatment withdrawal will be assessed by the
investigator. Starting with the initial dose of sacituzumab govitecan or TPC, Imaging
assessments will be obtained at least every 8 weeks until the occurrence of progression of
disease requiring discontinuation of further treatment. All patients, will be followed every
4 weeks during the first year and every 8 weeks thereafter for survival follow-up.

This is an international, multi-center, open-label, randomized, Phase III study in patients
with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including
a taxane) for their metastatic disease.

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to
the treatment of physician's choice (TPC) as measured by progression-free survival (PFS) in
patients with metastatic TNBC previously treated with at least two systemic chemotherapy
regimens.

The secondary objectives of the study are to compare between the two treatment groups for:

- Overall Survival (OS)

- Independently-determined Objective Response Rate (ORR), duration of response and time to
onset of response per RECIST 1.1 criteria

- Quality of life

- Safety (adverse events, safety laboratories, incidence of dose delays and dose
reductions, treatment discontinuations due to adverse events) Exploratory objectives
include exposure-response analysis for the efficacy (PFS and OS) and safety (incidence
of Grade 3-5 adverse events, related to UGT1A1 endpoints).

Four-Hundred and eighty-eight patients are anticipated to be enrolled. Approximately 150
institutions will participate in this study, including sites in North America and Europe.

Clinical sites will use standard ASCO/CAP criteria for the pathological diagnosis of TNBC,
defined as negative for estrogen receptor (ER), progesterone receptor (PR) and human
epidermal growth factor receptor 2 (HER2). Receptor results will be based on local
assessment. TNBC status will be reviewed centrally but these results are not required prior
to determining eligibility.

BRCA 1&2 mutational status will be collected, if known. Baseline serum biomarkers (CA15-3,
CA27-29, and CEA) will be measured. A single whole-blood sample will be also collected from
all patients for determination of UGT1A1 genotype for retrospective assessment predicting of
toxicity.

The Sponsor will request slides from prior (archived) biopsy or surgical specimens,
particularly for immunohistology documentation of tumor Trop-2 expression and other
appropriate tumor markers, including topoisomerase 1.

Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan
or treatment of physician choice (TPC), which needs to be selected prior to randomization
from one of the 4 allowed regimens. Randomization will be stratified by number of prior
chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs
Europe).

Patients will be treated until progression, unacceptable toxicity, study withdrawal, or
death, whichever comes first. Tumor progression leading to treatment withdrawal will be
assessed by the investigator.

No crossover to sacituzumab govitecan treatment will be allowed after discontinuing treatment
in the TPC arm, but otherwise there is no restriction on subsequent therapies that a patient
may receive after discontinuing the study.

All patients, including those prematurely terminating study participation, will be followed
every 4 weeks for survival follow-up.

Inclusion Criteria:

- Female or male patients, >18 years of age, able to understand and give written
informed consent.

- Histologically or cytologically confirmed TNBC based on the most recent analyzed
biopsy or other pathology specimen. TNBC determination as per local institution as per
standard guidelines.

- Refractory to or relapsed after at least two prior standard therapeutic regimens for
advanced/metastatic TNBC.

- Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or
advanced/metastatic setting.

- Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine,
gemcitabine, or vinorelbine) as per investigator assessment.

- ECOG performance score of 0 or 1 .

- Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.

- At least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including
small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy)
or major surgery, and recovered from all acute toxicities to Grade 1 or less (except
alopecia and peripheral neuropathy).

- At least 2 weeks beyond high dose systemic corticosteroids (however, low dose
corticosteroids < 20 mg prednisone or equivalent daily are permitted).

- Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC >
1,500 per mm3, platelets > 100,000 per mm3).

- Adequate renal and hepatic function (creatinine ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN,
AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).

- Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ≤
Grade 2 neuropathy are eligible).

- Patients with treated, non-progressive brain metastases, off high-dose steroids (>20
mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.

Exclusion Criteria:

- Women who are pregnant or lactating.

- Women of childbearing potential or fertile men unwilling to use effective
contraception during study until conclusion of 4-week post-treatment evaluation
period.

- Patients with Gilbert's disease.

- Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of
intestinal obstruction.

- Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are
eligible, while patients with other prior malignancies must have had at least a 3-year
disease-free interval.

- Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.

- Infection requiring intravenous antibiotic use within one week of enrollment.

- Patients with a history of an anaphylactic reaction to irinotecan.

- Other concurrent medical or psychiatric conditions that, in the Investigator's
opinion, may be likely to confound study interpretation or prevent completion of study
procedures and follow-up examinations.
We found this trial at
181
sites
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Aditya Bardia
Phone: 617-643-4732
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Phone: 239-274-9893
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Fort Myers, FL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1414 Kuhl Avenue
Orlando, Florida 32806
Principal Investigator: Rebecca Moroose
Phone: 321-841-2285
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Orlando, FL
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Albany, New York 12206
Phone: 518-489-2607
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4660 Kenmore Avenue
Alexandria, Virginia 22304
Phone: 703-832-5322
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Alhambra, California 91801
Principal Investigator: Sarah Hurvitz, MD
Phone: 310-582-6324
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Alpharetta, Georgia 30005
Phone: 770-496-9457
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Altamonte Springs, Florida 32701
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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515 West Mayfield Road
Arlington, Texas 76014
Phone: 817-759-7022
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Arlington, Virginia 22205
Phone: 703-528-7303
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Arlington Heights, Illinois 60005
Phone: 847-827-9060
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
Phone: 706-353-2990
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Phone: 770-496-9457
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, Georgia 30341
Phone: 770-496-9457
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Atlanta, Georgia 30342
Phone: 770-496-9457
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Aurora, Colorado 80012
Principal Investigator: Sami Diab, MD
Phone: 303-418-7639
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Aurora, Colorado 80045
Principal Investigator: Jennifer Diamond, MD
Phone: 720-848-0719
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6420 Rockledge Drive
Bethesda, Maryland 20817
Phone: 410-964-2212
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2600 Research Center Drive
Blacksburg, Virginia 24060
Phone: 540-381-5291
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Bonita Springs, Florida 34135
Phone: 239-274-9893
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Aditya Bardia
Phone: 617-643-4732
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02215
Principal Investigator: Aditya Bardia
Phone: 617-643-4732
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Boulder, Colorado 80303
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Bradenton, Florida 34209
Phone: 239-274-9893
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Brandon, Florida 33511
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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7704 Matapeake Business Drive
Brandywine, Maryland 20613
Phone: 410-964-2212
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101 Avenue du Laerbeek
Brussels, 1090
Phone: +0032-24775448
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Burbank, California 91505
Principal Investigator: Sarah Hurvitz, MD
Phone: 310-582-6324
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Burleson, Texas 76028
Phone: 817-759-7022
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Canton, Georgia 30114
Phone: 770-496-9457
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Cape Coral, Florida 33914
Phone: 239-274-9893
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101 Manning Drive
Chapel Hill, North Carolina 27599
Principal Investigator: Lisa Carey
Phone: 984-974-8658
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605 Glenwood Drive
Chattanooga, Tennessee 37404
Phone: 423-702-7897
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Chattanooga, Tennessee 37404
Phone: 423-698-1844
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Chesapeake, Virginia 23320
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, Illinois 60637
Phone: 773-834-2756
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Clearwater, Florida 33761
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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Cleveland, Tennessee 37311
Phone: 423-698-1844
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Clifton Park, New York 12065
Phone: 518-262-6696
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8926 Woodyard Road
Clinton, Maryland 20735
Phone: 410-964-2212
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Colorado Springs, Colorado 80907
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Columbia, Maryland 21044
Phone: 410-964-2212
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Columbus, Ohio 43210
Principal Investigator: Sagar Sardesai, MD
Phone: 614-685-6046
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Columbus, Ohio 43212
Principal Investigator: Sagar Sardesai, MD
Phone: 614-685-6046
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1498 Klondike Road Southwest
Conyers, Georgia 30094
Phone: 770-496-9457
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Phone: 612-863-8716
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coon Rapids, Minnesota 55433
Phone: 612-863-8716
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Coon Rapids, Minnesota 55433
Phone: 612-863-8716
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Coon Rapids, Minnesota 55433
Phone: 612-863-8716
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Coral Gables, Florida 33146
Principal Investigator: Alejandra Perez
Phone: 654-210-1171
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Cumming, Georgia 30041
Phone: 770-496-9457
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7777 Forest Lane
Dallas, Texas 75230
Phone: 972-566-4291
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Dallas, Texas 75246
Phone: 214-370-1000
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Danvers, Massachusetts 01923
Phone: 617-643-4732
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Daphne, Alabama 36526
Principal Investigator: Michael Meshad, MD
Phone: 251-433-9899
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Daytona Beach, Florida 32117
Principal Investigator: Robert Weaver, MD
Phone: 561-472-1696
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Decatur, Georgia 30033
Phone: 770-496-9457
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Decatur, Georgia 30033
Phone: 770-496-9547
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1192 East Newport Center Drive
Deerfield Beach, Florida 33442
Principal Investigator: Alejandra Perez
Phone: 654-210-1171
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Denton, Texas 76210
Phone: 940-382-1022
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Denver, Colorado 80218
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Denver, Colorado 80220
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Dickson, Tennessee 37055
Phone: 615-524-4239
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East Setauket, New York 11733
Principal Investigator: Malik Zufiqar
Phone: 631-675-5234
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Edmonds, Washington 98026
Phone: 206-386-6911
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Englewood, Colorado 80113
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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4323 Carothers Parkway
Franklin, Tennessee 37067
Phone: 615-524-4239
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Fridley, Minnesota 55432
Phone: 612-863-8716
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Fridley, Minnesota 55432
Phone: 612-863-8716
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Gainesville, Florida 32605
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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Gainesville, Virginia 20155
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Gallatin, Tennessee 37066
Phone: 615-524-4239
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Germantown, Tennessee 28138
Principal Investigator: Lee Schwartzberg, MD
Phone: 901-683-0055
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Greensburg, Pennsylvania 15601
Principal Investigator: Adam Brufsky, MD
Phone: 412-641-2261
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Hampton, Virginia 23666
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Hermitage, Tennessee 37076
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Houston, Texas 77030
Phone: 713-441-6662
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Independence, Missouri 64057
Phone: 816-276-9786
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751 Northeast Blakely Drive
Issaquah, Washington 98029
Phone: 206-386-6911
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Jonesboro, Georgia 30236
Phone: 770-496-9457
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Laguna Hills, California 92653
Principal Investigator: Sara Hurvitz, MD
Phone: 310-582-6324
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Lakewood, Colorado 80228
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Largo, Florida 33770
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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Lebanon, Tennessee 37087
Phone: 615-524-4239
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Lecanto, Florida 34461
Principal Investigator: Robert Weaver, MD
Phone: 615-524-4016
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Leesburg, Virginia 20176
Phone: 703-554-6800
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Littleton, Colorado 80120
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Lone Tree, Colorado 80124
Principal Investigator: Sami Diab, MD
Phone: 303-925-0700
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Longmont, Colorado 80501
Principal Investigator: Sami Diab, MD
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Longview, Texas 75601
Phone: 903-757-2122
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Los Angeles, California 90095
Principal Investigator: Sarah Hurvitz, MD
Phone: 310-582-6324
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Macon, Georgia 31217
Phone: 770-496-9457
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Marietta, Georgia 30060
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Miami, Florida 33176
Phone: 786-596-7710
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