NCT04534218 (REPROGRAM-01) is a Phase 2 clinical trial of Regorafenib in Colo-rectal Cancer, sponsored by Centre Hospitalier Universitaire de Besancon.

Who is sponsoring NCT04534218?

NCT04534218 is sponsored by Centre Hospitalier Universitaire de Besancon.

What drugs are being tested in NCT04534218?

Interventions in NCT04534218: Regorafenib, Cyclophosphamide, Capecitabine, Aspirin.

What condition does NCT04534218 study?

NCT04534218 studies Colo-rectal Cancer, Metastatic Cancer.

Is NCT04534218 still recruiting?

NCT04534218 is currently completed. Last updated 20 December 2024.

Last reviewed 2024-12-20 · How we verify

NCT04534218: REPROGRAM-01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer

Completed Phase 2 Last updated 20 December 2024

What this trial tests

Phase 2 trial testing Regorafenib in Colo-rectal Cancer in 49 participants. Completed in 13 December 2023.

Timeline

16 October 2020

Primary endpoint
13 December 2023

13 December 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	16 October 2020
Primary completion	13 December 2023
Estimated completion	13 December 2023
Sites	3 locations across France

Drugs / interventions tested

Regorafenib — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Capecitabine (capecitabine) — full drug profile →
Aspirin

Conditions studied

Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, any sex, with Colo-rectal Cancer or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting Cancer Cell Energy Metabolism in Colorectal Cancer: Opportunities and Challenges from Drug Repositioning.
Tomassini L, Pacifico T, Monteleone G, Stolfi C, et al · · 2025 · PMID 41439989 · DOI 10.3390/cells14241968

Verify or expand the search:

Other trials of Regorafenib

Trials testing the same drug.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07392866 — A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellula · Phase 2, PHASE3 · not yet recruiting
NCT06820957 — Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has S · Phase 2, PHASE3 · active not recruiting
NCT07223567 — A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cance · Phase 2 · withdrawn
NCT07134205 — The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Colo-rectal Cancer

Currently open trials in the same condition.

NCT06645015 — The AIDPRO-CRC Trial · NA · recruiting
NCT07145255 — Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07085169 — Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC · Phase 2 · recruiting
NCT06880055 — Shield Post-Approval Study Protocol · recruiting
NCT06905925 — The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy · NA · recruiting

Other Centre Hospitalier Universitaire de Besancon trials

Trials by the same sponsor.

NCT07492199 — High Depth Exome Sequencing on DNA From a Salivary Sample by Mouth Smear. · not yet recruiting
NCT07438015 — VEXUS-REA : Evaluation of Ultrasound Parameters of Venous Congestion in Patients in a Medical Intensive Care Unit · NA · not yet recruiting
NCT06796114 — Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Du · NA · recruiting
NCT06864065 — Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder · NA · recruiting
NCT07067762 — Botulinum Toxin Injections Into the Salivary Glands of Cerebrospinal Children With Chronic Sialorrhea · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04534218 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon
Last refreshed: 20 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04534218.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing