Gastrointestinal Stromal TumorsPhase 2NCT02607332
Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib
A Phase 2 study testing Paclitaxel in people with Gastrointestinal Stromal Tumors, run by Asan Medical Center at 1 site in South Korea.
Trial summary
With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Jan 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
- Age 20 years or older
- Histologically confirmed metastatic and/or advanced GIST with CD117(cluster of differentiation 117)(+), DOG-1(+), or mutation in KIT or PDGFRα gene(Platelet Derived Growth Factor Receptor)
- Failed (progressed and/or intolerable) after prior treatments for GIST, including at least both imatinib and sunitinib .
- Eastern Cooperative Oncology Group performance status of 0~2
- Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-Common Toxicity Criteria for Adverse Effects version 3.0
- At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors version 1.0
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- Adequate bone marrow, hepatic, renal, and other organ functions
- Neutrophil > 1,500/mm3
- Platelet > 100,000/mm3
- Hemoglobin > 8.0 g/dL
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase /Alanine transferase< 2.5 x ULN (or < 5 x ULM in case of liver metastases)
- Creatinine < 1.5 x ULN
- Life expectancy > 12 weeks
- Washout period of previous TKIs(Tyrosine Kinase Inhibitor) or chemotherapy for more than 4 times the half life.
- Provision of a signed written informed consent
Who cannot join
- Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- have the presence of cardiac disease,including a myocardial infarction within 6 months prior to study entry,Clinically significant cardiac disease (New York Heart Association, Class III or IV) or severe unstable angina pectoris, stroke or transient ischemic attack, Arrhythmia in need of treatment
- Uncontrolled infection
- Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
- Acute and chronic liver disease and all chronic liver impairment.(Patients with stable and chronic viral hepatitis are eligible are acceptable)
- Uncontrolled gastrointestinal toxicities with toxicity greater than NCI Common Toxicity Criteria for Adverse Effects grade 2
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- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality.
- The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleeding event.
- Major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy.
- Known diagnosis of HIV infection .
- History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients with brain metastases as assessed by radiologic imaging
- Alcohol or substance abuse disorder.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: A Trial of Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib
With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Paclitaxel
- Keywords
- single-center, prospective, single-arm, open-label, phase II
- 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.
PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | paclitaxel 80mg/m2/day on a Cycle1Day1, Cycle1Day8,Cycle1Day15 off 1 week schedule Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607332
- Sponsor's protocol ID
- AMC1501
- Status last verified
- Jan 2020
- First submitted
- 12 Nov 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib
- ClinicalTrials.gov ID
- NCT02607332
- Acronym / sponsor ID
- AMC1501
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- single-center, prospective, single-arm, open-label, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: Paclitaxelpaclitaxel 80mg/m2/day on a Cycle1Day1, Cycle1Day8,Cycle1Day15 off 1 week schedule |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 20 years or older
- Histologically confirmed metastatic and/or advanced GIST with CD117(cluster of differentiation 117)(+), DOG-1(+), or mutation in KIT or PDGFRα gene(Platelet Derived Growth Factor Receptor)
- Failed (progressed and/or intolerable) after prior treatments for GIST, including at least both imatinib and sunitinib .
- Eastern Cooperative Oncology Group performance status of 0~2
- Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-Common Toxicity Criteria for Adverse Effects version 3.0
Key exclusion criteria (13 listed)
- Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
- have the presence of cardiac disease,including a myocardial infarction within 6 months prior to study entry,Clinically significant cardiac disease (New York Heart Association, Class III or IV) or severe unstable angina pectoris, stroke or transient ischemic attack, Arrhythmia in need of treatment
- Uncontrolled infection
- Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
- Acute and chronic liver disease and all chronic liver impairment.(Patients with stable and chronic viral hepatitis are eligible are acceptable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel | Drug | Paclitaxel |
Primary outcome
Disease control rate
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Koo Kang, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel in people with Gastrointestinal Stromal Tumors, run by Asan Medical Center at 1 site in South Korea.
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 16 inclusion and 13 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 7 Jan 2020. 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 South Korea. 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?
Disease control rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020.