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CompletedNCT01985763Updated May 10, 2019Results posted

Genistein in Treatment of Metastatic Colorectal Cancer

A Phase 1/2 interventional study of Genistein in Colon Cancer, Rectal Cancer and Colorectal Cancer, sponsored by Sofya Pintova. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Sofya Pintova · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Colorectal neoplasms are the third most common malignancies in the United States. Patients with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The response rates to chemotherapy range from 35-40%.

Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-Fluorouracil and platinum compounds.

Based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. The aim of the study is to add genistein to the regimens of FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the tolerability of genistein when combined with chemotherapy

Secondary:

  • Evaluate Response Rate (RR) as measured by the radiologic RECIST criteria
  • Evaluate Progression Free Survival (PFS)
02

Conditions studied

  • Colon Cancer
  • Rectal Cancer
  • Colorectal Cancer

Keywords

  • Genistein
  • soy supplements
  • phytoestrogens
  • colon cancer
  • rectal cancer
  • colorectal cancer
  • metastatic
  • stage IV
  • FOLFOX
  • FOLFOX-Avastin
  • Chemotherapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 13 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Sofya Pintova as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult male and female patients ≥18 years old
  • Have pathologically confirmed colon or rectal carcinoma
  • Have metastatic (stage IV) disease
  • Have a plan by treating physician to receive FOLFOX or FOLFOX-Avastin
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2

  • Have adequate hematopoietic, hepatic and renal function

    1. Hematopoietic function

      • Hemoglobin ≥10g/dL
      • Absolute Neutrophil Count(ANC) ≥1,500cells/mm2
      • Platelet Count ≥100,000/µL

    2. Hepatic Function

      • Total bilirubin ≤ 1.5x the upper limit of normal
      • ALT and AST must each be ≤2,5x the upper limits of normal

    3. Renal Function

      • Estimated creatinine clearance (Clcr) ≥30 mL/minute
  • Are not pregnant and do not plan to become pregnant

Exclusion criteria

Exclusion Criteria:

  • Prior systemic chemotherapy for metastatic disease
  • History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
  • Patients taking MAO-inhibitors
  • History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
  • Unable to give informed consent or comply with clinical trial requirements
  • Uncontrolled hypertension
  • History of clinically significant GI bleeding within prior 2 months prior to enrollment
  • Presence of GI fistula
  • Prior history of bowel perforation
  • History of CNS thrombotic/embolic or ischemic events
  • Have past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with the follow up visits.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Genistein

    Genistein combined with FOLFOX or FOLFOX-Avastin Genistein 60mg/day orally for 7 days every 2 weeks. Genistein will be administered beginning 4 days prior to FOLFOX or FOLFOX-Avastin and continuing the 3 days of chemotherapy.

    Drug: Genistein

Interventions

  • DrugGenistein

    Genistein combined with FOLFOX or FOLFOX-Avastin

    Also known as: Bonistein

06

What researchers measure

Primary outcomes

  1. Number of Adverse Events

    Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.

    Time frame: up to 6 months

  2. Percent Change in Tumor Size

    Percent change in tumor size after cycle 6. Each cycle is 21 days.

    Time frame: end of Cycle 6

Secondary outcomes

  1. Response Rate RECIST Criteria

    Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Time frame: end of Cycle 6

  2. Number of Participants With an Overall Response Rate (ORR)

    Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period

    Time frame: up to 50 months

  3. Best Overall Response Rate RECIST Criteria

    Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions.

    Time frame: up to 50 months

  4. Number of Participants With Best Overall Response Rate (ORR)

    The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

    Time frame: up to 50 months

  5. Progression Free Survival (PFS)

    Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

    Time frame: up to 50 months

  6. Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months

    Patients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

    Time frame: 6 month and 12 month

  7. Overall Survival (OS)

    Overall Survival - Number of months still living since baseline

    Time frame: up to 50 months

07

Results

Posted May 10, 2019

Participant flow

Participant flow — Overall Study
MilestoneGenistein
Started13
Completed13
Not completed0

Outcome measures

PrimaryNumber of Adverse Events

Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.

Time frame:
up to 6 months
Reported as:
Number · events
Number of Adverse Events
eventsGenistein
Grade 1250
Grade 2119
Grade 324
Grade 40
PrimaryPercent Change in Tumor Size

Percent change in tumor size after cycle 6. Each cycle is 21 days.

Time frame:
end of Cycle 6
Reported as:
Median · Percent change
Percent Change in Tumor Size
Percent changeGenistein
Percent Change in Tumor Size-43.0 (-49.8 to -1.3)
SecondaryResponse Rate RECIST Criteria

Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time frame:
end of Cycle 6
Reported as:
Count of participants · Participants
Response Rate RECIST Criteria
ParticipantsGenistein
PR8
SD1
PD2
Not evaluable2
SecondaryNumber of Participants With an Overall Response Rate (ORR)

Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period

Time frame:
up to 50 months
Reported as:
Count of participants · Participants
Number of Participants With an Overall Response Rate (ORR)
ParticipantsGenistein
Number of Participants With an Overall Response Rate (ORR)6
SecondaryBest Overall Response Rate RECIST Criteria

Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions. PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions.

Time frame:
up to 50 months
Reported as:
Count of participants · Participants
Best Overall Response Rate RECIST Criteria
ParticipantsGenistein
PR6
SD3
PD2
Not evaluable2
SecondaryNumber of Participants With Best Overall Response Rate (ORR)

The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Time frame:
up to 50 months
Reported as:
Count of participants · Participants
Number of Participants With Best Overall Response Rate (ORR)
ParticipantsGenistein
Number of Participants With Best Overall Response Rate (ORR)8
SecondaryProgression Free Survival (PFS)

Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

Time frame:
up to 50 months
Reported as:
Median · months
Progression Free Survival (PFS)
monthsGenistein
Progression Free Survival (PFS)11.5 (4.9 to 21.7)
SecondaryPercent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months

Patients monitored for progression during the study period and 1 year following. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.

Time frame:
6 month and 12 month
Reported as:
Number · percentage of participants
Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months
percentage of participantsGenistein
6 months69 (48 to 99)
12 months38 (19 to 76)
SecondaryOverall Survival (OS)

Overall Survival - Number of months still living since baseline

Time frame:
up to 50 months
Reported as:
Median · months
Overall Survival (OS)
monthsGenistein
Overall Survival (OS)36.5 (29.5 to 50)

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Genistein0/13 (0%)0/13 (0%)13/13 (100%)
Genistein and Chemotherapy0/13 (0%)0/13 (0%)13/13 (100%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventGenisteinGenistein and Chemotherapy
HypertensionCardiac disorders1/1312/13
Cold SensitivityNervous system disorders0/1312/13
FatigueGeneral disorders2/1311/13
NauseaGastrointestinal disorders2/138/13
Acute Kidney InjuryRenal and urinary disorders0/138/13
AnorexiaGastrointestinal disorders0/138/13
Back PainMusculoskeletal and connective tissue disorders1/138/13
GERDGastrointestinal disorders0/138/13
NeuropathyNervous system disorders2/137/13
DiarrheaGastrointestinal disorders0/136/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Genistein
Median61 (32 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Genistein
Female4
Male9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Genistein
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White3
More than one race0
Unknown or Not Reported7
ECOG
ECOG(Participants)Genistein
08
15
Tumor Location
Tumor Location(Participants)Genistein
Right Colon3
Left Colon10
KRAS/NRAS
KRAS/NRAS(Participants)Genistein
Wild Type (WT)5
Mutated6
Unknown2
BRAF V600F
BRAF V600F(Participants)Genistein
WT11
Mutated0
Unknown2
Number of Metastatic Sites
Number of Metastatic Sites(Participants)Genistein
18
25
08

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
09

References and documents

Publications

  • DeCosse JJ, Ngoi SS, Jacobson JS, Cennerazzo WJ. Gender and colorectal cancer. Eur J Cancer Prev. 1993 Mar;2(2):105-15. doi: 10.1097/00008469-199303000-00003. PubMed 8461861 ↗
  • Hebert-Croteau N. A meta-analysis of hormone replacement therapy and colon cancer in women. Cancer Epidemiol Biomarkers Prev. 1998 Aug;7(8):653-9. PubMed 9718216 ↗
  • Haenszel W, Berg JW, Segi M, Kurihara M, Locke FB. Large-bowel cancer in Hawaiian Japanese. J Natl Cancer Inst. 1973 Dec;51(6):1765-79. doi: 10.1093/jnci/51.6.1765. No abstract available. PubMed 4797262 ↗
  • Hu JF, Liu YY, Yu YK, Zhao TZ, Liu SD, Wang QQ. Diet and cancer of the colon and rectum: a case-control study in China. Int J Epidemiol. 1991 Jun;20(2):362-7. doi: 10.1093/ije/20.2.362. PubMed 1917235 ↗
  • Nishi M, Yoshida K, Hirata K, Miyake H. Eating habits and colorectal cancer. Oncol Rep. 1997 Sep-Oct;4(5):995-8. doi: 10.3892/or.4.5.995. PubMed 21590181 ↗
  • Kono S, Imanishi K, Shinchi K, Yanai F. Relationship of diet to small and large adenomas of the sigmoid colon. Jpn J Cancer Res. 1993 Jan;84(1):13-9. doi: 10.1111/j.1349-7006.1993.tb02777.x. PubMed 8449821 ↗
  • Witte JS, Longnecker MP, Bird CL, Lee ER, Frankl HD, Haile RW. Relation of vegetable, fruit, and grain consumption to colorectal adenomatous polyps. Am J Epidemiol. 1996 Dec 1;144(11):1015-25. doi: 10.1093/oxfordjournals.aje.a008872. PubMed 8942431 ↗
  • Pereira MA, Barnes LH, Rassman VL, Kelloff GV, Steele VE. Use of azoxymethane-induced foci of aberrant crypts in rat colon to identify potential cancer chemopreventive agents. Carcinogenesis. 1994 May;15(5):1049-54. doi: 10.1093/carcin/15.5.1049. PubMed 8200067 ↗
  • Helms JR and Gallaher DD, The effect of dietary soy protein isolate and genistein on the development of preneoplastic lesions (aberrant crypts) in rats. 1995 Cancer Lett:125
  • Thiagarajan DG, Bennink MR, Bourquin LD, Kavas FA. Prevention of precancerous colonic lesions in rats by soy flakes, soy flour, genistein, and calcium. Am J Clin Nutr. 1998 Dec;68(6 Suppl):1394S-1399S. doi: 10.1093/ajcn/68.6.1394S. PubMed 9848506 ↗
  • Li Y, Ahmed F, Ali S, Philip PA, Kucuk O, Sarkar FH. Inactivation of nuclear factor kappaB by soy isoflavone genistein contributes to increased apoptosis induced by chemotherapeutic agents in human cancer cells. Cancer Res. 2005 Aug 1;65(15):6934-42. doi: 10.1158/0008-5472.CAN-04-4604. Erratum In: Cancer Res. 2005 Dec 1;65(23):11228. PubMed 16061678 ↗
  • Linsalata M, Russo F, Notarnicola M, Guerra V, Cavallini A, Clemente C, Messa C. Effects of genistein on the polyamine metabolism and cell growth in DLD-1 human colon cancer cells. Nutr Cancer. 2005;52(1):84-93. doi: 10.1207/s15327914nc5201_11. PubMed 16091008 ↗
  • Qi W, Weber CR, Wasland K, Savkovic SD. Genistein inhibits proliferation of colon cancer cells by attenuating a negative effect of epidermal growth factor on tumor suppressor FOXO3 activity. BMC Cancer. 2011 Jun 3;11:219. doi: 10.1186/1471-2407-11-219. PubMed 21639915 ↗
  • Miyaki M, Konishi M, Kikuchi-Yanoshita R, Enomoto M, Igari T, Tanaka K, Muraoka M, Takahashi H, Amada Y, Fukayama M, et al. Characteristics of somatic mutation of the adenomatous polyposis coli gene in colorectal tumors. Cancer Res. 1994 Jun 1;54(11):3011-20. PubMed 8187091 ↗
  • Zhang Y, Chen H. Genistein attenuates WNT signaling by up-regulating sFRP2 in a human colon cancer cell line. Exp Biol Med (Maywood). 2011 Jun 1;236(6):714-22. doi: 10.1258/ebm.2011.010347. Epub 2011 May 13. PubMed 21571909 ↗
  • Hwang JT, Ha J, Park OJ. Combination of 5-fluorouracil and genistein induces apoptosis synergistically in chemo-resistant cancer cells through the modulation of AMPK and COX-2 signaling pathways. Biochem Biophys Res Commun. 2005 Jul 1;332(2):433-40. doi: 10.1016/j.bbrc.2005.04.143. PubMed 15896711 ↗
  • Solomon LA, Ali S, Banerjee S, Munkarah AR, Morris RT, Sarkar FH. Sensitization of ovarian cancer cells to cisplatin by genistein: the role of NF-kappaB. J Ovarian Res. 2008 Nov 24;1(1):9. doi: 10.1186/1757-2215-1-9. PubMed 19025644 ↗
  • Yanhong H, et al, Genistein sensitizes ovarian carcinoma cells to chemotherapy by switching the cell cycle progression in vitro. J Medical Colleges of PLA:125-135
  • Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930. Erratum In: J Clin Oncol. 2008 Jun;26(18):3110. J Clin Oncol. 2009 Feb 1;27(4):653. PubMed 18421054 ↗
  • Metzner JE, Frank T, Kunz I, Burger D, Riegger C. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Arzneimittelforschung. 2009;59(10):513-20. doi: 10.1055/s-0031-1296435. PubMed 19998579 ↗
  • Setchell KD, Faughnan MS, Avades T, Zimmer-Nechemias L, Brown NM, Wolfe BE, Brashear WT, Desai P, Oldfield MF, Botting NP, Cassidy A. Comparing the pharmacokinetics of daidzein and genistein with the use of 13C-labeled tracers in premenopausal women. Am J Clin Nutr. 2003 Feb;77(2):411-9. doi: 10.1093/ajcn/77.2.411. PubMed 12540402 ↗
  • Takimoto CH, Glover K, Huang X, Hayes SA, Gallot L, Quinn M, Jovanovic BD, Shapiro A, Hernandez L, Goetz A, Llorens V, Lieberman R, Crowell JA, Poisson BA, Bergan RC. Phase I pharmacokinetic and pharmacodynamic analysis of unconjugated soy isoflavones administered to individuals with cancer. Cancer Epidemiol Biomarkers Prev. 2003 Nov;12(11 Pt 1):1213-21. PubMed 14652284 ↗
  • Fischer L, Mahoney C, Jeffcoat AR, Koch MA, Thomas BE, Valentine JL, Stinchcombe T, Boan J, Crowell JA, Zeisel SH. Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia. Nutr Cancer. 2004;48(2):160-70. doi: 10.1207/s15327914nc4802_5. PubMed 15231450 ↗
  • Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med. 2005 Oct;71(10):891-6. doi: 10.1055/s-2005-864186. PubMed 16254818 ↗
  • Busby MG, Jeffcoat AR, Bloedon LT, Koch MA, Black T, Dix KJ, Heizer WD, Thomas BF, Hill JM, Crowell JA, Zeisel SH. Clinical characteristics and pharmacokinetics of purified soy isoflavones: single-dose administration to healthy men. Am J Clin Nutr. 2002 Jan;75(1):126-36. doi: 10.1093/ajcn/75.1.126. PubMed 11756070 ↗
  • Pintova S, Dharmupari S, Moshier E, Zubizarreta N, Ang C, Holcombe RF. Genistein combined with FOLFOX or FOLFOX-Bevacizumab for the treatment of metastatic colorectal cancer: phase I/II pilot study. Cancer Chemother Pharmacol. 2019 Sep;84(3):591-598. doi: 10.1007/s00280-019-03886-3. Epub 2019 Jun 15. PubMed 31203390 ↗

Study documents

  • Study protocol · Sep 12, 2016
  • Statistical analysis plan · Sep 27, 2013

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01985763
Lead sponsor
Sofya Pintova
Collaborators
DSM Nutritional Products, Inc.
Responsible party
Sofya Pintova (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Sponsor-investigator
First posted
Nov 15, 2013
Start date
Nov 2013
Primary completion
Jan 19, 2017
Completion
Oct 31, 2018
Results posted
May 10, 2019
Last update
May 10, 2019

Study contacts

Randall F Holcombe, MD
principal investigator · Icahn School of Medicine at Mount Sinai
Sofya Pintova, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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