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CompletedNCT02606097Updated Mar 21, 2019

Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

A Phase 2 interventional study of regorafenib in Gastrointestinal Stromal Tumour (GIST), sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Apr 2014, registered Nov 2015).
Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Stromal Tumour (GIST)
03

In context

Gastrointestinal Stromal Tumors

333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.

Browse Gastrointestinal Stromal Tumors studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    regorafenib

    regorafenib 160 mg daily, 3 weeks on/1 week off

    Drug: regorafenib

Interventions

  • Drugregorafenib

    Also known as: stivarga

06

What researchers measure

Primary outcomes

  1. Overall clinical benefit rate

    complete response (CR), partial response (PR), and stable disease (SD)

    Time frame: till 2 weeks after last dose

Secondary outcomes

  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 outcomes

  1. Adverse events (AEs)

    Incidence of AEs will be shown and severity will be graded using NCI-CTCAE version 4.0

    Time frame: till 2 weeks after last dose

  2. Changes in clinical hematology laboratory result by hemoglobin (Hb)

    (unit: g/dL)

    Time frame: till 2 weeks after last dose

  3. Changes in clinical hematology laboratory result by hematocrit (Hct)

    (unit: %)

    Time frame: till 2 weeks after last dose

  4. Changes in clinical hematology laboratory result by platelet count

    (unit: 10\^9/L)

    Time frame: till 2 weeks after last dose

  5. Changes in clinical hematology laboratory result by red blood cell (RBC) count

    (unit: 10\^9/L)

    Time frame: till 2 weeks after last dose

  6. Changes in clinical hematology laboratory result by white blood cell (WBC) count

    (unit: 10\^9/L)

    Time frame: till 2 weeks after last dose

  7. Clinical hematology laboratory result by WBC differential

    (unit: %)

    Time frame: till 2 weeks after last dose

  8. Changes in clinical biochemistry laboratory result by potassium level

    (unit: mmol/L)

    Time frame: till 2 weeks after last dose

  9. Changes in clinical biochemistry laboratory result by calcium level

    (unit: mmol/L)

    Time frame: till 2 weeks after last dose

  10. Changes in clinical biochemistry laboratory result by glucose level

    (unit: mmol/L)

    Time frame: till 2 weeks after last dose

  11. Changes in clinical biochemistry laboratory result by lactate dehydrogenase (LDH) level

    (unit: U/L)

    Time frame: till 2 weeks after last dose

  12. Changes in clinical biochemistry laboratory result by blood urea nitrogen (BUN) level

    (unit: mmol/L)

    Time frame: till 2 weeks after last dose

  13. Changes in clinical biochemistry laboratory result by creatinine level

    (unit: mg/dL)

    Time frame: till 2 weeks after last dose

  14. Changes in clinical biochemistry laboratory result by total and direct bilirubin levels

    (unit: mg/dL)

    Time frame: till 2 weeks after last dose

  15. Changes in clinical biochemistry laboratory result by albumin levels

    (unit: g/L)

    Time frame: till 2 weeks after last dose

  16. Changes in clinical biochemistry laboratory result by alanine aminotransferase(ALT) levels

    (unit: U/L)

    Time frame: till 2 weeks after last dose

  17. Changes in clinical biochemistry laboratory result by aspartate aminotransferase (AST) levels

    (unit: U/L)

    Time frame: till 2 weeks after last dose

  18. Changes in clinical biochemistry laboratory result by alkaline phosphatase (ALP) level

    (unit: U/L)

    Time frame: till 2 weeks after last dose

  19. Changes in clinical biochemistry laboratory result by thyroid-stimulating hormone (TSH) level

    (unit: mIU/L)

    Time frame: till 2 weeks after last dose

  20. Changes in clinical biochemistry laboratory result by T3 level

    (unit: mIU/L)

    Time frame: till 2 weeks after last dose

  21. Changes in clinical biochemistry laboratory result by T4 level

    (unit: mIU/L)

    Time frame: till 2 weeks after last dose

  22. Changes in clinical urinalysis result by WBC count

    (unit: 10\^9/L)

    Time frame: till 2 weeks after last dose

  23. Changes in clinical urinalysis result by RBC count

    (unit: 10\^9/L)

    Time frame: till 2 weeks after last dose

  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

    (unit: mmol/L)

    Time frame: till 2 weeks after last dose

  27. Changes in clinical coagulation results by prothrombin time (PT)

    (unit: sec)

    Time frame: till 2 weeks after last dose

  28. Changes in clinical coagulation results by activated partial thromboplastin time (APTT)

    (unit: sec)

    Time frame: till 2 weeks after last dose

  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

    (unit: times/min)

    Time frame: till 2 weeks after last dose

  32. Changes in vital signs by pulse rate

    (unit: times/min)

    Time frame: till 2 weeks after last dose

  33. Changes in vital signs by systolic blood pressure

    (unit: mmHg)

    Time frame: till 2 weeks after last dose

  34. Changes in vital signs by diastolic blood pressure

    (unit: mmHg)

    Time frame: till 2 weeks after last dose

  35. Changes in vital signs by body temperature

    (unit: degree celsius)

    Time frame: till 2 weeks after last dose

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

References and documents

Publications

  • Yeh CN, Chen MH, Chen YY, Yang CY, Yen CC, Tzen CY, Chen LT, Chen JS. A phase II trial of regorafenib in patients with metastatic and/or a unresectable gastrointestinal stromal tumor harboring secondary mutations of exon 17. Oncotarget. 2017 Jul 4;8(27):44121-44130. doi: 10.18632/oncotarget.17310. PubMed 28487491 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02606097
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Yeh Chun-Nan (Professor and Chief, Department of Surgery, Chang Gung Memorial Hospital) — Principal investigator
First posted
Nov 17, 2015
Start date
Apr 2014
Primary completion
May 2018
Completion
May 2018
Last update
Mar 21, 2019

Study contacts

Chun-Nan Yeh, MD
principal investigator · Professor and Chief, Department of Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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