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Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer

NCT04008511 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-07-05

No results posted yet for this study

Summary

This is an interventional, randomized open-label, parallel-group, multicenter, dose escalation phase Ib/II study, to investigate the combination of Regorafenib and XELOX as 2nd line treatment in mCRC patients.

Conditions

Interventions

DRUG

Regorafenib

Phase Ib Group A: Regorafenib 120mg + XELOX; Group B: Regorafenib 160mg + XELOX; Group C: Regorafenib 80mg + XELOX.

DRUG

Regorafenib

Phase II: Regorafenib MAD qd po for 14 days, every 3 weeks.

DRUG

Capecitabine

Capecitabine 1000 mg/m2 bid po for 14 days.

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2, day 1, every 3 weeks

Sponsors & Collaborators

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • The First People's Hospital of Jingzhou

    collaborator OTHER

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Yunpeng Liu, M.D.,Ph.D. · First Hospital of China Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2023-03-31
Completion
2024-03-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04008511 on ClinicalTrials.gov