A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer
Public ClinicalTrials.gov record NCT03597581. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of RGX-202-01 (Ompenaclid) , a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. The single agent ompenaclid dose escalation stage and the ompenaclid in combination with FOLFIRI and bevacizumab dose escalation stage of the study has been completed; the expansion stage of ompenaclid in combination with FOLFIRI and bevacizumab is ongoing. In April-24 a protocol amendment added a new dose escalation and expansion stage which will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study.
Study identification
- NCT ID
- NCT03597581
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 4, 2018
- Primary completion
- Mar 30, 2025
- Completion
- Mar 30, 2025
- Last update posted
- Apr 2, 2025
2018 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Prescott Valley | Arizona | 86314 | — |
| Arizona Oncology Associates, PC - HOP E | Tucson | Arizona | 85704 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Sharp HealthCare | San Diego | California | 92123 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| UCLA Department of Medicine | Santa Monica | California | 90404 | — |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | 19713 | — |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Dartmouth | Lebanon | New Hampshire | 03756 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | — |
| Thomas Jefferson | Philadelphia | Pennsylvania | 19107 | — |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29605 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology, P.A | McAllen | Texas | 78503 | — |
| Texas Oncology, P.A | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03597581, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03597581 live on ClinicalTrials.gov.