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Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

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ClinicalTrials.gov Identifier: NCT02606097
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yeh Chun-Nan, Chang Gung Memorial Hospital

Brief Summary:
The main purpose of this study is to examine whether regorafenib treatment can help people with gastrointestinal stromal tumours (GIST) and have gene mutation on c-kit exon 17. The safety of regorafenib treatment is also examined.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumour (GIST) Drug: regorafenib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Regorafenib in Metastatic Gastrointestinal Stromal Tumours With C-KIT exon17 Mutation
Actual Study Start Date : April 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: regorafenib
regorafenib 160 mg daily, 3 weeks on/1 week off
Drug: regorafenib
Other Name: stivarga




Primary Outcome Measures :
  1. Overall clinical benefit rate [ Time Frame: till 2 weeks after last dose ]
    complete response (CR), partial response (PR), and stable disease (SD)


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: till study end, estimated 3 years ]
  2. Overall survival (OS) [ Time Frame: till study end, estimated 3 years ]

Other Outcome Measures:
  1. Adverse events (AEs) [ Time Frame: till 2 weeks after last dose ]
    Incidence of AEs will be shown and severity will be graded using NCI-CTCAE version 4.0

  2. Changes in clinical hematology laboratory result by hemoglobin (Hb) [ Time Frame: till 2 weeks after last dose ]
    (unit: g/dL)

  3. Changes in clinical hematology laboratory result by hematocrit (Hct) [ Time Frame: till 2 weeks after last dose ]
    (unit: %)

  4. Changes in clinical hematology laboratory result by platelet count [ Time Frame: till 2 weeks after last dose ]
    (unit: 10^9/L)

  5. Changes in clinical hematology laboratory result by red blood cell (RBC) count [ Time Frame: till 2 weeks after last dose ]
    (unit: 10^9/L)

  6. Changes in clinical hematology laboratory result by white blood cell (WBC) count [ Time Frame: till 2 weeks after last dose ]
    (unit: 10^9/L)

  7. Clinical hematology laboratory result by WBC differential [ Time Frame: till 2 weeks after last dose ]
    (unit: %)

  8. Changes in clinical biochemistry laboratory result by potassium level [ Time Frame: till 2 weeks after last dose ]
    (unit: mmol/L)

  9. Changes in clinical biochemistry laboratory result by calcium level [ Time Frame: till 2 weeks after last dose ]
    (unit: mmol/L)

  10. Changes in clinical biochemistry laboratory result by glucose level [ Time Frame: till 2 weeks after last dose ]
    (unit: mmol/L)

  11. Changes in clinical biochemistry laboratory result by lactate dehydrogenase (LDH) level [ Time Frame: till 2 weeks after last dose ]
    (unit: U/L)

  12. Changes in clinical biochemistry laboratory result by blood urea nitrogen (BUN) level [ Time Frame: till 2 weeks after last dose ]
    (unit: mmol/L)

  13. Changes in clinical biochemistry laboratory result by creatinine level [ Time Frame: till 2 weeks after last dose ]
    (unit: mg/dL)

  14. Changes in clinical biochemistry laboratory result by total and direct bilirubin levels [ Time Frame: till 2 weeks after last dose ]
    (unit: mg/dL)

  15. Changes in clinical biochemistry laboratory result by albumin levels [ Time Frame: till 2 weeks after last dose ]
    (unit: g/L)

  16. Changes in clinical biochemistry laboratory result by alanine aminotransferase(ALT) levels [ Time Frame: till 2 weeks after last dose ]
    (unit: U/L)

  17. Changes in clinical biochemistry laboratory result by aspartate aminotransferase (AST) levels [ Time Frame: till 2 weeks after last dose ]
    (unit: U/L)

  18. Changes in clinical biochemistry laboratory result by alkaline phosphatase (ALP) level [ Time Frame: till 2 weeks after last dose ]
    (unit: U/L)

  19. Changes in clinical biochemistry laboratory result by thyroid-stimulating hormone (TSH) level [ Time Frame: till 2 weeks after last dose ]
    (unit: mIU/L)

  20. Changes in clinical biochemistry laboratory result by T3 level [ Time Frame: till 2 weeks after last dose ]
    (unit: mIU/L)

  21. Changes in clinical biochemistry laboratory result by T4 level [ Time Frame: till 2 weeks after last dose ]
    (unit: mIU/L)

  22. Changes in clinical urinalysis result by WBC count [ Time Frame: till 2 weeks after last dose ]
    (unit: 10^9/L)

  23. Changes in clinical urinalysis result by RBC count [ Time Frame: till 2 weeks after last dose ]
    (unit: 10^9/L)

  24. Changes in clinical urinalysis result by pH level [ Time Frame: till 2 weeks after last dose ]
  25. Changes in clinical urinalysis result by protein level [ Time Frame: till 2 weeks after last dose ]
  26. Changes in clinical urinalysis result by glucose level [ Time Frame: till 2 weeks after last dose ]
    (unit: mmol/L)

  27. Changes in clinical coagulation results by prothrombin time (PT) [ Time Frame: till 2 weeks after last dose ]
    (unit: sec)

  28. Changes in clinical coagulation results by activated partial thromboplastin time (APTT) [ Time Frame: till 2 weeks after last dose ]
    (unit: sec)

  29. Changes in clinical coagulation results by international normalized ratio (INR) [ Time Frame: till 2 weeks after last dose ]
  30. Physical examination [ Time Frame: till 2 weeks after last dose ]
  31. Changes in vital signs by respiratory rate [ Time Frame: till 2 weeks after last dose ]
    (unit: times/min)

  32. Changes in vital signs by pulse rate [ Time Frame: till 2 weeks after last dose ]
    (unit: times/min)

  33. Changes in vital signs by systolic blood pressure [ Time Frame: till 2 weeks after last dose ]
    (unit: mmHg)

  34. Changes in vital signs by diastolic blood pressure [ Time Frame: till 2 weeks after last dose ]
    (unit: mmHg)

  35. Changes in vital signs by body temperature [ Time Frame: till 2 weeks after last dose ]
    (unit: degree celsius)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

An eligible subject must fulfill all of the following inclusion criteria:

  • Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written IC.
  • Pathologically confirmed gastrointestinal stromal tumours.
  • All patients had received imatinib or sunitinib.
  • Pathological confirmed c-kit exon 17 mutation.
  • At least one measurable lesion in a non-irradiated area or allowed to be tracked whether there are circumstances recurrence by computed tomography (CT) or magnetic resonance imaging (MRI).
  • Aged > 20 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function: 1) Absolutely neutrophil count >= 1.5 x10^9/L or white blood cell count (WBC) >= 4x10^9/L; 2) Hemoglobin >= 9 g/dL; 3) Platelet count >= 100x10^9/L.
  • Adequate liver function: 1) Total bilirubin <= 1.5x the upper limit of normal (ULN); 2) Alanine Aminotransferase (ALT) & Aspartate Aminotransferase (AST) <= 2.5x ULN if without liver metastasis or <= 5x ULN if with hepatic metastasis; 3) Alkaline phosphatase <= 2.5x ULN if without liver metastasis or <= 5x ULN if with hepatic metastasis or bone metastasis; 4) Bilirubin < 2x ULN.
  • Adequate renal function: creatinine <1.5x ULN.
  • Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

Subject will not meet any of the following exclusion criteria:

  • Major surgery within four weeks prior to entering the study.
  • Patients with central nervous system (CNS) metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients who with unstable angina (angina symptoms at rest, new-onset angina (begun within the last 3 months) or myocardial infarction history 6 months before entry.
  • Cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Congestive heart failure New York Heart Association (NYHA) class 2.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.
  • 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.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 years except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
  • Mental status is not fit for clinical trial.
  • Cannot take study medication orally.
  • Fertile men and women unless using a reliable and appropriate contraceptive method.
  • Patients with evidence or history of any bleeding diathesis, irrespective of severity.
  • Any hemorrhage or bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks prior to the start of study medication.
  • Non-healing wound, ulcer, or bone fracture.
  • Renal failure requiring hemo-or peritoneal dialysis.

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): NCT02606097


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chun-Nan Yeh, MD Professor and Chief, Department of Surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yeh Chun-Nan, Professor and Chief, Department of Surgery, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02606097     History of Changes
Other Study ID Numbers: 17298
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases