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Gastrointestinal Stromal Tumour (GIST)Phase 2NCT02606097

Regorafenib in GIST With Secondary C-KIT Exon 17 Mutation

A Phase 2 study testing regorafenib in people with Gastrointestinal Stromal Tumour (GIST), run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastrointestinal Stromal Tumour (GIST)
What is being tested?
regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTaiwan
Study dates
Apr 2014to May 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Phase 2 Study of Regorafenib in Metastatic Gastrointestinal Stromal Tumours With C-KIT exon17 Mutation

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.

Being tested
regorafenib
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • regorafenibDrug

    Also called stivarga

Study groups in NCT02606097
Study groupRoleWhat they receive
regorafenibExperimentalregorafenib 160 mg daily, 3 weeks on/1 week off
Receives: Drug: regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall clinical benefit rate

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

    Measured: till 2 weeks after last dose

Secondary outcomes (2)

  1. Progression free survival (PFS)

    Measured: till study end, estimated 3 years

  2. Overall survival (OS)

    Measured: till study end, estimated 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02606097
Sponsor's protocol ID
17298
Status last verified
Mar 2019
First submitted
12 Nov 2015
Last updated
21 Mar 2019
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing regorafenib in people with Gastrointestinal Stromal Tumour (GIST), run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall clinical benefit rate (time frame: till 2 weeks after last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02606097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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