Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

NCT02606097 | Completed Phase 2

• 1 other identifier: 17298
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumour (GIST)

Outcome Measures

Primary Outcomes (1)

• Overall clinical benefit rate

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

  till 2 weeks after last dose

Secondary Outcomes (2)

• Progression free survival (PFS)

  till study end, estimated 3 years

• Overall survival (OS)

  till study end, estimated 3 years

Other Outcomes (35)

• Adverse events (AEs)

  till 2 weeks after last dose

• Changes in clinical hematology laboratory result by hemoglobin (Hb)

  till 2 weeks after last dose

• Changes in clinical hematology laboratory result by hematocrit (Hct)

  till 2 weeks after last dose

Study Arms (1)

regorafenib

EXPERIMENTAL

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

Drug: regorafenib

Interventions

regorafenib DRUG

Also known as: stivarga

regorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28487491 DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Chun-Nan Yeh, MD

  Professor and Chief, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief, Department of Surgery

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 17, 2015
• Study Start: April 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

TW (1)