NCT02095054 is a Phase 1 clinical trial of Regorafenib in Advanced Cancers, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT02095054?

NCT02095054 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT02095054?

Interventions in NCT02095054: Regorafenib, Cetuximab, Questionnaire.

What condition does NCT02095054 study?

NCT02095054 studies Advanced Cancers.

Is NCT02095054 still recruiting?

NCT02095054 is currently completed. Last updated 1 April 2021.

Last reviewed 2021-04-01 · How we verify

NCT02095054

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

Regorafenib and Cetuximab in Patients With Advanced Malignancy

Completed Phase 1 Last updated 1 April 2021

What this trial tests

Phase 1 trial testing Regorafenib in Advanced Cancers in 39 participants. Completed in 27 March 2020.

Timeline

19 March 2014

Primary endpoint
27 March 2020

27 March 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	19 March 2014
Primary completion	27 March 2020
Estimated completion	27 March 2020
Sites	1 location across United States

Drugs / interventions tested

Regorafenib — full drug profile →
Cetuximab (cetuximab) — full drug profile →
Questionnaire

Conditions studied

Advanced Cancers — all drugs for Advanced Cancers →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

12 and older, any sex, with Advanced Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Drug Resistance in Colorectal Cancer: From Mechanism to Clinic.
Wang Q, Shen X, Chen G, Du J. · · 2022 · cited 104× · PMID 35740594 · DOI 10.3390/cancers14122928
Therapy for Cancer: Strategy of Combining Anti-Angiogenic and Target Therapies.
Comunanza V, Bussolino F. · · 2017 · cited 62× · PMID 29270405 · DOI 10.3389/fcell.2017.00101
EGFR, the Lazarus target for precision oncology in glioblastoma.
Lin B, Ziebro J, Smithberger E, Skinner KR, et al · · 2022 · cited 34× · PMID 36125064 · DOI 10.1093/neuonc/noac204
Trial watch: Tumor-targeting monoclonal antibodies for oncological indications.
Vacchelli E, Pol J, Bloy N, Eggermont A, et al · · 2015 · cited 32× · PMID 25949870 · DOI 10.4161/2162402x.2014.985940
First-in-human trial of multikinase VEGF inhibitor regorafenib and anti-EGFR antibody cetuximab in advanced cancer patients.
Subbiah V, Khawaja MR, Hong DS, Amini B, et al · · 2017 · cited 21× · PMID 28422758 · DOI 10.1172/jci.insight.90380

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 Advanced Cancers

Currently open trials in the same condition.

NCT06001749 — Psilocybin in Cancer Pain Study · Phase 2 · recruiting
NCT03375983 — Plasmodium Immunotherapy for Advanced Cancers · Phase 1, PHASE2 · recruiting
NCT01375114 — The Effects of Ginseng on Cancer-Related Fatigue · Phase 1, PHASE2 · active not recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

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 NCT02095054 (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 M.D. Anderson Cancer Center
Last refreshed: 1 April 2021

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/NCT02095054.

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