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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307500
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Ovarian Cancer Melanoma Sarcoma Thymoma Type B3 Thymoma Type B2 Thymic Carcinoma Drug: Regorafenib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND
Study Start Date : December 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Regorafenib

Arms and Interventions
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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 Name: Stivarga


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307500


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02307500    
Other Study ID Numbers: ONC-2014-001
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Thymoma
Thymus Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Lymphatic Diseases