Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02606097
• Date of registration: 12/11/2015
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation
• Scientific title: A Phase 2 Study of Regorafenib in Metastatic Gastrointestinal Stromal Tumours With C-KIT exon17 Mutation
• Date of first enrolment: April 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02606097
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Chun-Nan Yeh, MD
• Affiliation: Professor and Chief, Department of Surgery

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Stromal Tumour (GIST)

Intervention(s)

Drug: regorafenib

Primary Outcome(s)

Overall clinical benefit rate [Time Frame: till 2 weeks after last dose]

Secondary Outcome(s)

Overall survival (OS) [Time Frame: till study end, estimated 3 years]

Progression free survival (PFS) [Time Frame: till study end, estimated 3 years]

Secondary ID(s)

17298

Source(s) of Monetary Support

Please refer to primary and secondary sponsors