RECRUITING

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Official Title

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Quick Facts

Study Start:2021-10-22
Study Completion:2029-11-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04929223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Reference Study ID Number: WO42758 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

UAB Comprehensive Cancer Center
Birmingham, Alabama, 35233
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85259
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
cCare
Encinitas, California, 92024
United States
USC Norris Cancer Center
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA
Los Angeles, California, 90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Stanford Cancer Center
Stanford, California, 94305-5820
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Eastern Ct Hema/Onco Assoc
Norwich, Connecticut, 06360
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, 70809
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902
United States
New York Cancer & Blood Specialists - Bronx
Bronx, New York, 10469-5930
United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, 11042-1116
United States
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, 10028
United States
New York Cancer & Blood Specialists
Port Jefferson Station, New York, 11776
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Hematology Oncology Salem
Salem, Oregon, 97301
United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Lumi Research
Kingwood, Texas, 77339
United States
Swedish Cancer Inst.
Seattle, Washington, 98104
United States
Medical Oncology Associates
Spokane, Washington, 99208
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-22
Study Completion Date2029-11-07

Study Record Updates

Study Start Date2021-10-22
Study Completion Date2029-11-07

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Colorectal Cancer