Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy (RESOUND)

September 9, 2022 updated by: Istituto Clinico Humanitas

An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND

This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each tumour will be assessed by itself. Regorafenib 40 mg tablets will be used in the study. Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Subjects will continue on treatment until at least one of the following occurs (main criteria):

  • Progressive Disease (PD) by radiological assessments or clinical progression
  • Death
  • Unacceptable toxicity
  • Subject withdraws consent
  • Treating physician determines discontinuation of treatment is in the subject's best interest
  • Substantial non-compliance with the protocol

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Patients older then 18 years.
  3. Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment, included Pancreatic cancer, Ovarian cancer, Melanoma, Sarcoma
  4. At least one measurable lesion according to Response Evaluation Criteria In solid tumor
  5. Eastern Cooperative Oncology Group Performance Status: 0-1
  6. Life expectancy of at least 12 weeks
  7. Adequate bone marrow, liver and renal function as assessed by the following laboratory : Hemoglobin > 9.0 g/dl Absolute neutrophil count > 1,500/mm3 Platelet count > 100,000/μl White blood cells >3.0 x 109/L Total bilirubin <1.5 times the upper limit of normal Alanine amino transferase and aspartate amino transferase <2.5 x upper limit of normal (<5 x upper limit of normal for patients with liver involvement) Serum creatinine <1.5 x upper limit of normal Alkaline phosphatase <2.5 x Upper Limit of Normal Prothrombin time / Partial prothrombin time <1.5 x Upper Limit of Normal Lipase ≤ 1.5 x the Upper Limit of Normal
  8. Able to swallow and retain oral medication.
  9. Estimated creatinine clearance > 30ml/min as calculated using the Cockcroft-Gault equation
  10. Resolution of any toxic effects of prior therapy to NCI Common Terminology Criteria for Adverse Event, Version 4.0, grade ≤ 1 .
  11. Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

  1. Prior treatment with regorafenib.
  2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
  3. Congestive heart failure >New York Heart Association class 2
  4. Unstable angina), new-onset angina.Myocardial infarction less than 6 months before start of study drug
  5. Myocardial infarction less than 6 months before start of study drug.
  6. Cardiac arrhythmias requiring anti-arrhythmic therapy
  7. Uncontrolled hypertension.
  8. Pleural effusion or ascites that causes respiratory compromise
  9. Ongoing infection > Grade 2
  10. Known history of human immunodeficiency virus infection.
  11. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
  12. Subjects with seizure disorder requiring medication.
  13. History of organ allograft. Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
  14. Any hemorrhage or bleeding event > Common Toxicity Criteria for Adverse Effects Grade 3
  15. Arterial or venous thrombotic or embolic events within the 6 months before start of study medication
  16. Known history or symptomatic metastatic brain or meningeal tumors
  17. Suggestive or consistent with central nervous system disease
  18. Renal failure requiring hemo-or peritoneal dialysis.
  19. Dehydration Common Toxicity Criteria for Adverse Effects v. 4.0 Grade >1.
  20. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
  21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
  22. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
  23. Interstitial lung disease with ongoing signs and symptoms
  24. Persistent proteinuria of CTCAE Grade 3
  25. Any malabsorption condition.
  26. Concomitant participation or participation within the last 30 days in another clinical trial
  27. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks before starting to receive study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regorafenib
Regorafenib 160 mg (40 mg tablets), po, every day for 3 weeks of every 4 week cycle
Drug: Regorafenib
oral therapy
Other Names:
  • Stivarga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activity of regorafenib screening, in terms of 2-months progression free survival rate
Time Frame: 2 months
to evaluate activity of regorafenib, in terms of 2-months progression free survival rate
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognosis in terms of progression-free survival
Time Frame: 36 months
to explore the prognosis in terms of progression-free survival calculated from the first day of regorafenib treatment to the date of tumor progression or death, whichever occurs first.
36 months
overall survival (OS)
Time Frame: 36 months
to explore overall survival (OS) measured from the first day of regorafenib treatment until the date of death from any cause or the date of the last contact, at which the patients will be censored
36 months
safety profile of regorafenib according to NCI-CTC v.3
Time Frame: 3 months
to assess the safety profile of regorafenib according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-2014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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