Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

287

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

August 7, 2023

Study Completion Date

October 30, 2023

Conditions
Cancer Therapy-Related DiarrheaChemotherapy-related DiarrheaAdult Solid TumorProphylaxis of DiarrheaSymptomatic Relief of DiarrheaTargeted Therapy-related Diarrhea
Interventions
DRUG

Crofelemer 125 MG [Mytesi]

Randomized, Double-blind, Placebo-controlled, two arm trial

DRUG

Placebo

Matching placebo tablets

Trial Locations (52)

500

Changhua Christian Hospital, Changhua

1414

Fleischer Medical Center, Buenos Aires

3100

Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER), Paraná

4000

9 of July Sanatorium, San Miguel de Tucumán

10461

Jacobi Medical Center, The Bronx

11000

National Cancer Research Center, Belgrade

11776

North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists, Port Jefferson Station

20817

American Oncology Partners of Maryland, Bethesda

21204

Institute of Pulmonary Diseases of Vojvodina, Kamenitz

Oncology Institute of Vojvodina (IOV), Kamenitz

22031

Inova Schar Cancer Institute, Fairfax

22601

Shenandoah Oncology Associates, Winchester

32909

Cancer Care Centers of Brevard, Inc., Palm Bay

33180

GenesisCare USA, Aventura

33322

BRCR Global, Plantation

33710

Advanced Research Institute, St. Petersburg

38138

The West Clinic Research, Germantown

44718

Gabrail Cancer Research, Canton

55404

Minnesota Oncology Hematology, P.A., Minneapolis

68114

Nebraska Methodist Hospital, Omaha

75020

Texas Oncology - Denison, Denison

75028

Texas Oncology, P.A. - Flower Mound, Flower Mound

77030

MD Anderson Cancer Center, Houston

77598

Texas Oncology - Gulf Coast, Webster

78130

Texas Oncology - New Braunfels, New Braunfels

80218

SCL Health Research Institute, Lafayette

86314

Arizona Oncology Associates PC - HAL, Prescott

90602

PIH Health Whittier Hospital, Whittier

91204

The Oncology Institute of Hope and Innovation, Glendale

92801

Pacific Cancer Medical Center Inc, Anaheim

92882

The Oncology Institute of Hope and Innovation, Corona

97239

Oregon Health & Science University (OHSU) Knight Cancer Institute, Portland

98405

MultiCare Institute for Research and Innovation, Tacoma

100226

National Taiwan University Hospital, Taipei

112201

Taipei Veterans General Hospital, Taipei

404332

China Medical University Hospital, Taichung

736402

Chi Mei Medical Center - LiouYing Branch, Tainan City

75075-7787

Texas Oncology - Plano East, Plano

C1019ABS

Medical Center Austral, Buenos Aires

Unknown

Buenos Aires British Hospital, Buenos Aires

Cordoba Oncology Institute (IONC), Córdoba

CEDIT Diagnostic and Treatment Center, Salta

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

S3000FFV

Isis Specialized Clinic, Santa Fe

0112

"LLC Todua Clinic", Tbilisi

0159

Archangel St. Michael Multiprofile Clinical Hospital LTD, Tbilisi

JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi

0172

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC, Tbilisi

0186

LTD Caucasus Medical Centre, Tbilisi

11 080

Clinical Hospital Center Bezanijska Kosa, Belgrade

34 000

University Clinical Center Kragujevac, Kragujevac

18 000

University Clinical Center Nis, Niš

Sponsors
All Listed Sponsors
lead

Napo Pharmaceuticals, Inc.

INDUSTRY

NCT04538625 - Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy | Biotech Hunter | Biotech Hunter