Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03796884|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : December 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenoma||Drug: Linaclotide Other: Placebo||Phase 2|
I. To determine whether, compared to placebo, linaclotide administered as a single oral daily dose x 7 days, induces a pharmacodynamics (PD) effect on cGMP levels, based on biopsy samples of adenomas or resected colorectal adenocarcinomas.
I. To compare Ki-67, guanylin levels and GUCY2C expression in adenomas and cancers versus normal tissue.
II. To confirm the safety and tolerability of linaclotide in sporadic adenoma and cancer patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Bioactivity in Patients With Sporadic Colorectal Adenomas and With Colorectal Cancer|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Arm I (linaclotide)
Patients receive linaclotide PO daily on days 1-7 and undergo standard of care colonoscopy or surgery on day 8.
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-7 and undergo standard of care colonoscopy or surgery on day 8.
- Pharmacodynamics effect on cGMP levels [ Time Frame: Up to 2 years ]Will compare cGMP levels in adenomas between study arms using a two-sample t-test (alpha=.05; two-sided) or Wilcoxon rank sum test.
- Incidence of adverse events (AEs) [ Time Frame: From day 7 to day 14 ]All participants will be evaluated for toxicity from the time of their first dose of linaclotide or placebo. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to summarize adverse events associated with linaclotide.
- Ki-67 expression [ Time Frame: Up to 2 years ]Wilcoxon rank sum test will be used to compare Ki-67 expression in adenomas across arms.
- GUCY2C expression [ Time Frame: Up to 2 years ]Wilcoxon rank sum and Fisher's exact tests will be used to compare GUCY2C expression between study arms.
- Guanylin levels [ Time Frame: Up to 2 years ]Wilcoxon rank sum and Fisher's exact tests will be used to compare guanylin levels between study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796884
|Contact: Scott Waldman, MDemail@example.com|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: David Weinberg, MD firstname.lastname@example.org|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19126|
|United States, Washington|
|VA Puget Sound Health Care Sysem||Not yet recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Jason Dominitz, MD email@example.com|
|Principal Investigator:||Scott Waldman, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|