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Metastatic Colorectal CancerPhase 1/2NCT04008511

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

A Phase 1/2 study testing Regorafenib, Capecitabine and Oxaliplatin in people with Metastatic Colorectal Cancer, run by China Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Regorafenib, Capecitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
Jul 2019to Mar 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign a consent form
  • Age> 18 years <75 years
  • Pathological diagnosis as colorectal adenocarcinoma
  • Recurrence or metastatic disease
  • Metastatic colorectal cancer with disease progression after 1st line treatment by 5-Fu and Irinotecan
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
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  • ECOG score 0-1 points
  • Life expectancy ≥3 months
  • Can provide more than 10 paraffin sections of tumor tissue
  • End of radiotherapy without or with non-targeted lesions> 4 weeks (only for use outside of the test site)
  • At least one measurable lesion (according to RECIST 1.1)
  • Previously treated radiotherapy lesions cannot be considered as target lesions, unless the radiotherapy lesions clear progress.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases ≤ 5 times ULN
  • Serum albumin ≥ 3.0g / dL
  • Serum alkaline phosphatase (AKP) ≤2.5 times ULN
  • Total bilirubin <1.5mg / dL
  • Estimated creatinine clearance (CLcr) ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
  • Lipase ≤ 1.5 x the ULN
  • Neutrophil absolute count (ANC) ≥ 1500 / mm3, hemoglobin (Hb)> 9g/dl, platelets> 100,000 / mm3
  • Pregnant or breast-feeding patients:
  • 1) Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.
  • 2) Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment

Who cannot join

  • Received oxaliplatin and capecitabine in the 1st line treatment
  • Cannot be orally administered
  • Subjects with brain metastases and / or cancerous meningitis.
  • Surgical treatment was performed within 4 weeks before enrollment (excluding diagnostic biopsies)
  • Non-healing wound, non-healing ulcer, or non-healing bone fracture
  • Patients with evidence or history of any bleeding diathesis, irrespective of severity
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  • Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication.
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication)
  • Congestive heart failure ≥ New York Heart Association (NYHA) class 2
  • Uncontrolled cardiac arrhythmias
  • Ongoing infection > Grade 2 NCI CTCAE
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
  • Anti-tumor cytotoxic drug therapy, biologic medication (eg, monoclonal antibody), immunotherapy (eg, interleukin 2 or interferon), or other investigational drug therapy within 4 weeks prior to enrollment
  • Subjects with active tuberculosis (TB) who are on anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening
  • Patients with complications requiring long-term use of immunosuppressive drug therapy or systemic or topical corticosteroids requiring immunosuppressive doses (prednisone or other equivalent hormones at doses> 10 mg / day)
  • Use of strong CYP3A4 inducers or inhibitors
  • In the first 4 weeks before the group vaccinated any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.)
  • Pregnancy or lactation
  • 5 years with other malignancies, except for non-melanoma skin cancer
  • Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 5.0).
  • Human immunodeficiency virus (HIV) positive
  • Hepatitis B surface antigen (HBsAg) positive simultaneous detection of Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) copy number positive (quantitative detection ≥ 1000cps / ml)
  • Chronic hepatitis C blood screening positive [Hepatitis C virus (HCV) antibody positive]
  • No legal capacity
  • Any other disease or condition that the investigator considers may affect program adherence or affect the subject's signature of informed consent (ICF), or are not suitable for participating in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Yunpeng Liu, M.D.,Ph.D. contact

86-24-83282312

cmu_trial@163.com

Xiujuan Qu, M.D.,Ph.D. contact

86-24-83282312

cmuquxiujuan@163.com

China1 site

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

Other trials in China

About this study

Official title: Phase Ib/II Study of Regorafenib and XELOX Combination as 2nd Line Treatment in Metastatic Colorectal Cancer Patients

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.

Read the detailed description

This is a phase Ib/II trial, comprising Phase Ib and Phase II two parts. Phase Ib study is an open-label, single-arm, multicenter, dose escalation study of Regorafenib plus XELOX. In Phase Ib, max 15 patients(pts) could be enrolled based on the modified toxicity probability interval (mTPI) design. Phase II study is a randomized, open-label, parallel-group, multicenter study comparing Regorafenib + XELOX to XELOX alone. In phase II trial, a total of 39 patients will be recruited and randomized 2:1 into two groups, where 26 patients under Regorafenib + XELOX, and 13 patients under XELOX alone.

Keywords
Metastatic Colorectal Cancer, Regorafenib, Second line, XELOX
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Also called Stivarga

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

  • RegorafenibDrug

    Also called Stivarga

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

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1000 mg/m2 bid po for 14 days.

  • OxaliplatinDrug

    Also called ELOXATIN®

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

Study groups in NCT04008511
Study groupRoleWhat they receive
Phase Ib: Regorafenib plus XELOXExperimentalPhase Ib followed a Modified toxicity probability interval (mTPI) design to determine the maximum administered dose (MAD), there are 3 dose levels, and the dose level started from Group A: Group A: Regorafenib 120mg + XELOX; Group B: Regorafenib 160mg + XELOX; Group C: Regorafenib 80mg + XELOX. (Regorafenib qd po for 14 days, every 3 weeks; XELOX: Oxaliplatin 130 mg/m2 IV, day 1, Capecitabine 1000 mg/m2 bid po for 14 days)
Receives: Drug: Regorafenib; Drug: Capecitabine; Drug: Oxaliplatin
Phase II: Regorafenib plus XELOXExperimentalRegorafenib MAD qd po for 14 days, every 3 weeks, Oxaliplatin 130 mg/m2 IV on day 1, Capecitabine 1000 mg/m2 bid po for 14 days.
Receives: Drug: Regorafenib; Drug: Capecitabine; Drug: Oxaliplatin
Phase II: XELOXActive comparatorOxaliplatin 130 mg/m2 IV on day 1, Capecitabine 1000 mg/m2 bid po for 14 days.
Receives: Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    The MTD is defined as the highest dose that can be given so that toxicity probability is below the target toxicity PT=30%.

    Measured: 6 weeks

  2. Progression-free survival (PFS)

    PFS is defined as the time (days) from start of study treatment to date of first observed disease progression (investigator's radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented.

    Measured: 1 year

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety and tolerability

    Measured: 3 years

Secondary outcomes (2)

  1. Disease control rate (DCR)

    • DCR is defined as the percentage of patients, whose overall best response was not progressive disease.

    Measured: 3 years

  2. Overall response rate (ORR)

    • ORR is defined as the percentage of patients with complete response (CR) or partial response (PR).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study startJul 2019 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008511
Sponsor's protocol ID
CLOG1901
Other IDs
IMPACT 20872
Status last verified
Jul 2019
First submitted
2 Jul 2019
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Regorafenib, Capecitabine and Oxaliplatin in people with Metastatic Colorectal Cancer, run by China Medical University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunpeng Liu, M.D.,Ph.D. (86-24-83282312, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04008511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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