Gastrointestinal Stromal TumorNCT02776878
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST
A study testing dasatinib in people with Gastrointestinal Stromal Tumor, run by Peking University Cancer Hospital & Institute at 7 sites in China.
Trial summary
The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 7 sitesChina
- Study dates
- May 2016to May 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent/metastatic gastrointestinal stromal tumor (GIST). Immunohistochemically, the detection KIT and/or DOG-1 are/is positive
- Patients must have measurable disease meeting the requirement of RECIST 1.1
- Received the gene mutation detection of c - kit/PDGFRA
- Subjects with mutation in exon 11, in exon 9 and wild type c-kit/PDGFRA have failed to imatinib and sunitinib
- Subjects with primary mutation in exon 17 or 18 have failed to imatinib
- Subjects with primary mutation in exon 11 and secondary mutation in exon 17 or 18 have failed to imatinib
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- Subjects with mutation in exon 18 of PDGFRA,have received TKI or not
- Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
- Expected OS ≥3 months
- Ability to understand and the willingness to sign a written informed consent document
- Subject will comply with the study procedures and therapy
Who cannot join
- Local or metastatic GIST is resectable
- Unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/PDGFRA
- AST and/or ALT > 2.5 times ULN, or Bilirubin >1.5 times upper limit of normal (ULN)
- Neutrophil count < 1.5 x 10^9/L, or Platelet count <75 x 10^9/L, or Hemoglobin<90g/L
- Cr >1.5×ULN
- Other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma
Show all 12Show fewer
- Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage
- Within the past 5 years, subjects have one of the following disease: myocardial infarction, serious/instable angina pectoris, symptomatic congestive heart failure or cerebrovascular accident from coronary/peripheral artery bypass grafting
- Known human immunodeficiency virus positivity
- Joining in other trail
- Women who are pregnant or lactating; No contraception for subject during childbearing period
- Subject with other serious acute and chronic physical or mental problems, or laboratory abnormality, will increase the risks associated with trail or drug. It will also interference the judgment of the results. In the judgment of the investigator, subject is inadequate to participant the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Li Jian, 008613601310849, oncogene@163.com
Shen Lin
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Wu Xin, 008613683285233
Wu Xin
- Not yet recruiting
West China Hospital , Sichuan University
Chengdu, Sichuan
Zhang Bo, 008613881952600
Zhang Bo
- Not yet recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong
Zhang Xinhua, 008613828463644
Zhang Xinhua
- Not yet recruiting
No.81 Hospital of Chinese People's Liberation Army
Nanjing, Jiangsu
Liu Xiufeng, 008613357837170
Liu Xiufeng
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Zhou Ye, 008613661736873
Zhou Ye
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Liang Xiaobo
Liang Xiaobo
About this study
Official title: A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor
The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- dasatinib
- 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.
dasatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib is given orally 50 mg 2 times a day for the first week, if subject is tolerate, then increased to 70 mg 2 times a day. Dasatinib will be continued until unacceptable toxicity and progression. Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survive, calculated from registration until progression or death
Measured: 2 years
Secondary outcomes (4)
Overall survival, overall survival will be calculated from registration until death
Measured: 2 years
Adverse drug reactions according to NCI CTCAE v4.0
Measured: 2 years, Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v4.0.
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Measured: 2 years
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University Cancer Hospital & Institute
- Investigators
- Shen Lin, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776878
- Sponsor's protocol ID
- DRAMA GIST
- Status last verified
- May 2016
- First submitted
- 17 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor
- ClinicalTrials.gov ID
- NCT02776878
- Acronym / sponsor ID
- DRAMA GIST
- Conditions
- Gastrointestinal Stromal Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 18 May 2016 (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.
The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: dasatinibDasatinib is given orally 50 mg 2 times a day for the first week, if subject is tolerate, then increased to 70 mg 2 times a day. Dasatinib will be continued until unacceptable toxicity and progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed recurrent/metastatic gastrointestinal stromal tumor (GIST). Immunohistochemically, the detection KIT and/or DOG-1 are/is positive
- Patients must have measurable disease meeting the requirement of RECIST 1.1
- Received the gene mutation detection of c - kit/PDGFRA
- Subjects with mutation in exon 11, in exon 9 and wild type c-kit/PDGFRA have failed to imatinib and sunitinib
- Subjects with primary mutation in exon 17 or 18 have failed to imatinib
Key exclusion criteria (12 listed)
- Local or metastatic GIST is resectable
- Unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/PDGFRA
- AST and/or ALT > 2.5 times ULN, or Bilirubin >1.5 times upper limit of normal (ULN)
- Neutrophil count < 1.5 x 10^9/L, or Platelet count <75 x 10^9/L, or Hemoglobin<90g/L
- Cr >1.5×ULN
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 |
|---|---|---|
| dasatinib | Drug | Dasatinib |
Primary outcome
Progression-free survive, calculated from registration until progression or death
Time frame: 2 years
4 secondary outcomes
Overall survival, overall survival will be calculated from registration until death
Time frame: 2 years
Adverse drug reactions according to NCI CTCAE v4.0
Time frame: 2 years, Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v4.0.
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Time frame: 2 years
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Shen Lin principal investigator
Peking University Cancer Hospital & Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dasatinib in people with Gastrointestinal Stromal Tumor, run by Peking University Cancer Hospital & Institute at 7 sites in China.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Jian (008613601310849, oncogene@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survive, calculated from registration until progression or death (time frame: 2 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 18 May 2016.