Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02095054 · ClinicalTrials.gov registry record · Phase 1
Regorafenib and Cetuximab in Patients With Advanced Malignancy
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02095054: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02095054 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02095054, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
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.
Primary Outcome
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle (four weeks), determined as the highest dose studied in which the incidence of DLT is less than 33%. DLT defined as any grade 3 or 4 non-hematologic toxicity related to study medication(s) (except nausea and vomiting responsive to appropriate regimens, alopecia, or correctable electrolyte imbalances), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) despite supportive care; any Grade
Interventions
- DRUG Cetuximab
- DRUG Regorafenib
- BEHAVIORAL Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-03-19 |
| Est. Completion | 2020-03-27 |
| Phase | Phase 1 |
What the finished NCT02095054 record still lists
NCT02095054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT02095054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02095054 about?
NCT02095054 is a clinical study titled "Regorafenib and Cetuximab in Patients With Advanced Malignancy". 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.
What is the current status of trial NCT02095054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-03-19. Estimated completion is 2020-03-27.
What interventions are being tested in trial NCT02095054?
The interventions under investigation include: Cetuximab (DRUG), Regorafenib (DRUG), Questionnaire (BEHAVIORAL).
Who is sponsoring clinical trial NCT02095054?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02095054's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI