Spots Global Cancer Trial Database for ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer
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Trial Identification
Brief Title: ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer
Official Title: A Phase 1/2, Open Label, Dose-Escalation and Expansion Study of Oral ORIN1001 With and Without Chemotherapy in the Treatment of Subjects With Solid Tumors
Study ID: NCT03950570
Interventions
Study Description
Brief Summary: This study evaluates the anti-tumor effects of ORIN 1001 in patients with advanced solid tumors or relapsed refractory metastatic breast cancer (patients with progressive disease after receiving at least two lines of therapy in the advanced setting).
Detailed Description: This is a first in human, Phase 1/2, open label, dose escalation and dose expansion study that consists of two stages: Phase 1: A dose escalation stage to determine the MTD/RP2D of ORIN1001 when given as a single agent in up to 30 subjects with advanced solid tumors. In addition, a dose escalation stage to determine the MTD/RP2D of daily ORIN1001 in combination with Abraxane given intravenously in up to 18 subjects with relapsed refractory metastatic breast cancer (TNBC or ER+ HER2-). Phase 2: An expansion stage of ORIN1001 alone (Cohort A: TNBC) and in combination with Abraxane (Cohort B: Myc+; Cohort C: ER+ HER2-, and Cohort D: TNBC) to estimate efficacy in up to 120 subjects with relapsed refractory metastatic breast cancer.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
UCLA Health Burbank Specialty Care, Burbank, California, United States
UCLA Health Laguna Hills Cancer Care, Laguna Hills, California, United States
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC) - Oncology Center - Westwood, Westwood, California, United States
University of Colorado Anschutz Medical Campus, Denver, Colorado, United States
Highlands Ranch Hospital, Highlands Ranch, Colorado, United States
University of Colorado Lone Tree Medical Center, Lone Tree, Colorado, United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Cancer Center of Kansas, Wichita, Kansas, United States
St Lukes Cancer Institute, Kansas City, Missouri, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)), Buffalo, New York, United States
Northwell Health, New Hyde Park, New York, United States
Northwell Heath Cancer Institute, New Hyde Park, New York, United States
NYU Langone Health, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Baylor College of Medicine Medical Center, Houston, Texas, United States
Contact Details
Name: Mothaffar F Rimawi, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR
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