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Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy (OnTARGET)

Primary Purpose

Cancer Therapy-Related Diarrhea, Chemotherapy-related Diarrhea, Adult Solid Tumor

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crofelemer 125 MG [Mytesi]
Placebo
Sponsored by
Napo Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Therapy-Related Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients to receive targeted cancer therapy drugs that have a reported an all grade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors, cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors.

    2. Patients able to provide written informed consent.

    3. Men and women ≥ 18 years of age.

    4. Pathologically and/or radiologically confirmed diagnosis of solid tumors scheduled to receive targeted cancer therapy.

    5. Patients eligible to receive targeted cancer therapy per NCCN (National Comprehensive Cancer Network) guidelines and/or standard-of-care practice, with or without cycle chemotherapy.

    6. Patient can receive concomitant cycle [standard] chemotherapy agents together with their targeted cancer therapy treatment regimens.

    7. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 and expected to survive a 12-week course of targeted therapy with or without chemotherapy

    8. Negative urine pregnancy test at time of informed consent for women of childbearing potential.

Exclusion Criteria:

  • 1. Patients receiving any type of immunotherapy including but not limited to immune checkpoint inhibitors that inhibit negative regulatory components of immune response such as cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and the programmed cell death protein-1 and its ligand (PD1/ PDL1) and IL-2 cancer immunotherapy.

    2. Any cancer therapy for which antidiarrheal (antimotility) medications in the prophylaxis setting is mandatory, including but not limited to patients receiving neratinib and irinotecan.

    3. Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.).

    4. Ongoing diarrhea and/or diarrheal episodes within the previous 7 days prior to randomization into the study.

    5. Laxative use within 7 days prior to randomization or a history of constipation requiring the use of laxatives for more than ≥ 30 consecutive days.

    6. Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN), AST (SGOT) and ALT (SPGT) > 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma or hepatic metastases), serum creatinine > 2.0 mg/dL or 177 μmol/L.

    1. NOTE: Investigator discretion will determine continued eligibility after randomization occurs, in the event the liver function test results are greater than (>) the proposed upper limit of normal.

      7. Use of other investigational drugs within 4 weeks of signed informed consent or foreseen use during the study.

      8. Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotic for procedures, including but not limited to port placement, is permitted) prior to randomization.

      9. Total colectomy and/or any type of gastrointestinal ostomy.

      10. Major abdominal or pelvic surgery within the past 3 months.

      11. Previous (within 1 month) or planned abdominal and/or pelvic radiation.

      12. Fecal incontinence from ongoing radiation-induced diarrhea or constipation

      13. Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasitics, and anti-viral drugs.

      14. Inability to comply with study requirements as judged by the Investigator.

      15. Pregnant and/or breastfeeding.

Sites / Locations

  • Arizona Oncology Associates PC - HAL
  • Pacific Cancer Medical Center Inc
  • The Oncology Institute of Hope and Innovation
  • The Oncology Institute of Hope and Innovation
  • PIH Health Whittier Hospital
  • SCL Health Research Institute
  • GenesisCare USA
  • Cancer Care Centers of Brevard, Inc.
  • BRCR Global
  • Advanced Research Institute
  • American Oncology Partners of Maryland
  • Minnesota Oncology Hematology, P.A.
  • Nebraska Methodist Hospital
  • Jacobi Medical Center
  • North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists
  • Gabrail Cancer Research
  • Oregon Health & Science University (OHSU) Knight Cancer Institute
  • The West Clinic Research
  • Texas Oncology - Denison
  • Texas Oncology, P.A. - Flower Mound
  • MD Anderson Cancer Center
  • Texas Oncology - New Braunfels
  • Texas Oncology - Plano East
  • Texas Oncology - Gulf Coast
  • Inova Schar Cancer Institute
  • Shenandoah Oncology Associates
  • MultiCare Institute for Research and Innovation
  • Fleischer Medical Center
  • Medical Center Austral
  • Buenos Aires British Hospital
  • Cordoba Oncology Institute (IONC)
  • Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
  • CEDIT Diagnostic and Treatment Center
  • Isis Specialized Clinic
  • 9 of July Sanatorium
  • LLC "Todua Clinic"
  • Archangel St. Michael Multiprofile Clinical Hospital LTD
  • JSC K. Eristavi National Center of Experimental and Clinical Surgery
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
  • LTD Caucasus Medical Centre
  • Clinical Hospital Center Bezanijska Kosa
  • National Cancer Research Center
  • University Clinical Center Kragujevac
  • University Clinical Center Nis
  • Institute of Pulmonary Diseases of Vojvodina
  • Oncology Institute of Vojvodina (IOV)
  • Changhua Christian Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Chi Mei Medical Center - LiouYing Branch
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Crofelemer

Arm Description

Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food.

Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food.

Outcomes

Primary Outcome Measures

Frequency of Number of Loose/watery Stools
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.

Secondary Outcome Measures

Proportion of Durable, Clinical Responders
Proportion of "durable responders" defined as the proportion of subjects with ≤7 loose and/or watery bowel movements per week for at least 50% of the time over the Stage 1 double-blind placebo-controlled primary treatment period (Stage 1).
Maximum Number of Weekly Loose/Watery Stools
Maximum number of weekly unformed (loose and/or watery) bowel movements from Week 1 through end of Week 12.
Fecal Incontinence
Mean number of fecal incontinence episodes from Week 1 through end of Week 12

Full Information

First Posted
August 28, 2020
Last Updated
May 24, 2023
Sponsor
Napo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04538625
Brief Title
Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy
Acronym
OnTARGET
Official Title
A Phase 3 Multicenter, Randomized, Double-blind Placebo-controlled Trial Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients With Solid Tumors Receiving Targeted-cancer Therapies With or Without Standard Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Napo Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I. After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.
Detailed Description
A randomized, placebo controlled, double blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapy containing regimens. Diarrhea grading will be done according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE Ver. 5.0). Randomization will be at a 1:1 ratio with subjects randomized either to crofelemer 125 mg delayed-release tablets or matching placebo tablets administered orally twice daily with or without food. Randomization will be stratified by the type of targeted cancer therapy and by tumor type. Placebo and crofelemer treatment will be initiated concomitantly with the administration of targeted cancer therapy-containing regimens. The Stage I double-blind placebo-controlled primary treatment phase will be the first 12-week period to accommodate targeted cancer therapy with approximately three (3) cycle chemotherapy regimens (if needed) over the inclusive 12-week period after initiation of crofelemer or placebo treatment in Stage I. After completing the Stage I treatment phase (12 weeks), and after the LPLV of the primary Stage I treatment phase, the primary and secondary endpoints will be analyzed. The subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, Visit 5 will be the last study visit. Subjects who enter into the Stage II extension phase will continue on their originally assigned study treatment commenced at the beginning of Stage I.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Therapy-Related Diarrhea, Chemotherapy-related Diarrhea, Adult Solid Tumor, Prophylaxis of Diarrhea, Symptomatic Relief of Diarrhea, Targeted Therapy-related Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, placebo controlled, double blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors receiving targeted cancer therapy containing regimens. Diarrhea grading will be done according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE Ver. 5.0).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, placebo controlled
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the placebo arm, will receive oral doses of matching placebo tablets twice daily with or without food.
Arm Title
Crofelemer
Arm Type
Experimental
Arm Description
Subjects randomized to the crofelemer arm, will receive oral doses of crofelemer 125mg delayed-release tablets twice daily with or without food.
Intervention Type
Drug
Intervention Name(s)
Crofelemer 125 MG [Mytesi]
Intervention Description
Randomized, Double-blind, Placebo-controlled, two arm trial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
Frequency of Number of Loose/watery Stools
Description
The frequency of diarrhea as measured by the average number of loose/watery stools per week will be evaluated as a continuous endpoint.
Time Frame
For the entire 12-week double-blind placebo-controlled treatment period (The Stage 1 Primary Treatment Phase).
Secondary Outcome Measure Information:
Title
Proportion of Durable, Clinical Responders
Description
Proportion of "durable responders" defined as the proportion of subjects with ≤7 loose and/or watery bowel movements per week for at least 50% of the time over the Stage 1 double-blind placebo-controlled primary treatment period (Stage 1).
Time Frame
Initial 12-week (Stage 1) period of the study.
Title
Maximum Number of Weekly Loose/Watery Stools
Description
Maximum number of weekly unformed (loose and/or watery) bowel movements from Week 1 through end of Week 12.
Time Frame
Initial 12-week (Stage 1) period of the study.
Title
Fecal Incontinence
Description
Mean number of fecal incontinence episodes from Week 1 through end of Week 12
Time Frame
Initial 12-week (Stage 1) period of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients to receive targeted cancer therapy drugs that have a reported an all grade diarrhea incidence of 50% or higher (e.g., tyrosine kinase inhibitors, cdk inhibitors, anti-EGFR, etc., for treatment of solid tumors. 2. Patients able to provide written informed consent. 3. Men and women ≥ 18 years of age. 4. Pathologically and/or radiologically confirmed diagnosis of solid tumors scheduled to receive targeted cancer therapy. 5. Patients eligible to receive targeted cancer therapy per NCCN (National Comprehensive Cancer Network) guidelines and/or standard-of-care practice, with or without cycle chemotherapy. 6. Patient can receive concomitant cycle [standard] chemotherapy agents together with their targeted cancer therapy treatment regimens. 7. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 and expected to survive a 12-week course of targeted therapy with or without chemotherapy 8. Negative urine pregnancy test at time of informed consent for women of childbearing potential. Exclusion Criteria: 1. Patients receiving any type of immunotherapy including but not limited to immune checkpoint inhibitors that inhibit negative regulatory components of immune response such as cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and the programmed cell death protein-1 and its ligand (PD1/ PDL1) and IL-2 cancer immunotherapy. 2. Any cancer therapy for which antidiarrheal (antimotility) medications in the prophylaxis setting is mandatory, including but not limited to patients receiving neratinib and irinotecan. 3. Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.). 4. Ongoing diarrhea and/or diarrheal episodes within the previous 7 days prior to randomization into the study. 5. Laxative use within 7 days prior to randomization or a history of constipation requiring the use of laxatives for more than ≥ 30 consecutive days. 6. Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days prior to signing consent: Total bilirubin > upper limit of normal (ULN), AST (SGOT) and ALT (SPGT) > 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma or hepatic metastases), serum creatinine > 2.0 mg/dL or 177 μmol/L. NOTE: Investigator discretion will determine continued eligibility after randomization occurs, in the event the liver function test results are greater than (>) the proposed upper limit of normal. 7. Use of other investigational drugs within 4 weeks of signed informed consent or foreseen use during the study. 8. Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotic for procedures, including but not limited to port placement, is permitted) prior to randomization. 9. Total colectomy and/or any type of gastrointestinal ostomy. 10. Major abdominal or pelvic surgery within the past 3 months. 11. Previous (within 1 month) or planned abdominal and/or pelvic radiation. 12. Fecal incontinence from ongoing radiation-induced diarrhea or constipation 13. Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasitics, and anti-viral drugs. 14. Inability to comply with study requirements as judged by the Investigator. 15. Pregnant and/or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Okhuysen, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pravin Chaturvedi, PhD
Organizational Affiliation
Napo Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology Associates PC - HAL
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86314
Country
United States
Facility Name
Pacific Cancer Medical Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
PIH Health Whittier Hospital
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
SCL Health Research Institute
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
GenesisCare USA
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Cancer Care Centers of Brevard, Inc.
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32909
Country
United States
Facility Name
BRCR Global
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Advanced Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
American Oncology Partners of Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore Hematology Oncology Associates dba New York Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Gabrail Cancer Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oregon Health & Science University (OHSU) Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The West Clinic Research
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology - Denison
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
Texas Oncology, P.A. - Flower Mound
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - New Braunfels
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Texas Oncology - Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Facility Name
Texas Oncology - Gulf Coast
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Shenandoah Oncology Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
MultiCare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Fleischer Medical Center
City
Buenos Aires
ZIP/Postal Code
1414
Country
Argentina
Facility Name
Medical Center Austral
City
Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
Buenos Aires British Hospital
City
Buenos Aires
Country
Argentina
Facility Name
Cordoba Oncology Institute (IONC)
City
Córdoba
Country
Argentina
Facility Name
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
City
Paraná
ZIP/Postal Code
3100
Country
Argentina
Facility Name
CEDIT Diagnostic and Treatment Center
City
Salta
Country
Argentina
Facility Name
Isis Specialized Clinic
City
Santa Fe
ZIP/Postal Code
S3000FFV
Country
Argentina
Facility Name
9 of July Sanatorium
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
LLC "Todua Clinic"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Archangel St. Michael Multiprofile Clinical Hospital LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
JSC K. Eristavi National Center of Experimental and Clinical Surgery
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
LTD Caucasus Medical Centre
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11 080
Country
Serbia
Facility Name
National Cancer Research Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Institute of Pulmonary Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Oncology Institute of Vojvodina (IOV)
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Facility Name
Chi Mei Medical Center - LiouYing Branch
City
Tainan
ZIP/Postal Code
736402
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100226
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112201
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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Bowen JM. Mechanisms of TKI-induced diarrhea in cancer patients. Curr Opin Support Palliat Care. 2013 Jun;7(2):162-7. doi: 10.1097/SPC.0b013e32835ec861.
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Crutchley RD, Miller J, Garey KW. Crofelemer, a novel agent for treatment of secretory diarrhea. Ann Pharmacother. 2010 May;44(5):878-84. doi: 10.1345/aph.1M658. Epub 2010 Apr 13.
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Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

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