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Trial record 6 of 137 for:    regorafenib

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

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ClinicalTrials.gov Identifier: NCT02307500
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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 who have progressed after standard therapy.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Ovarian Cancer Melanoma Sarcoma 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib
U.S. FDA Resources

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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


Contacts
Contact: Armando Santoro, MD +39 02 8224 4080 armando.santoro@cancercenter.humanitas.it
Contact: Silvia Bozzarelli, MD +39 02 8224 7255 silvia.bozzarelli@cancercenter.humanitas.it

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

Publications:

Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02307500     History of Changes
Other Study ID Numbers: ONC-2014-001
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases