Gastrointestinal Stromal TumorsPhase 1/2NCT04254939
A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
A Phase 1/2 study testing CS3007 (BLU-285) in people with Gastrointestinal Stromal Tumors, run by CStone Pharmaceuticals at 16 sites in China.
Trial summary
This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- CS3007 (BLU-285)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 16 sitesChina
- Study dates
- 15 Aug 2019to 11 Apr 2023
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene.
- For phase II study:
- Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene.
- Group 2: Chinese third-line and fourth-line or later subjects with unresectable GIST that has progressed after standard treatment and/or do not tolerate standard treatment, and do not have a known D842V mutation in the PDGFRα gene.
- Subjects with at least one measurable lesion as defined per mRECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Who cannot join
- Subject has any of the laboratory results that meet exclusion criteria
- Subjects who have previously received antineoplastic medication, including Chinese herbal drugs or Chinese medicine products with antineoplastic indications, for less than 5 half-lives or 14 days, whichever is shorter, prior to the first dose of the investigational product.
- The subject received neutrophil growth factor support within 14 days prior to the first dose of investigational product.
- Subjects received treatment with a strong inhibitor or strong or moderate inducer of cytochrome P450 (CYP) 3A4 within 14 days prior to the first dose of study drug, or requires continuous intake of above medications or foods during study period.
- Subject received a major surgery (not including minor procedures, e.g., central venous catheterization, tumor needle biopsy, feeding tube placement) within 14 days prior to the first dose of investigational product.
- Diagnosis of any other malignancy within 1 year prior to the first dose of investigational product or the subject is under treatment for another malignancy.
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- Corrected QT interval > 450 msec calculated using Fridericia's formula.
- Subject has history of seizure (e.g. epilepsy) or requires antiepileptic medication treatment.
- History of cerebrovascular accident or transient ischemic attack within one year prior to the first dose of the investigational product.
- Known risk of intracranial hemorrhage, e.g., history of cerebral aneurysm or subdural or subarachnoid hemorrhage.
- With primary brain malignancy or brain metastasis.
- With clinically significant, uncontrolled cardiovascular disease, including congestive heart failure of New York Heart Association (NYHA) class II, III or IV, myocardial infarction or unstable angina in the past 6 months, or uncontrolled hypertension.
- Unwilling or unable to comply with scheduled visits, treatment plan, laboratory tests or other study procedures/restrictions.
- With previous or current clinically significant disorder, medical condition, history of surgery, physical issue or laboratory finding, which, in the investigator's judgment, might affect the subject's safety, change the absorption, distribution, metabolism or excretion of the investigational product, or interfere with the evaluation of study result.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou, Fujian
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
The First Affiliated Hospital Zhe Jiang University
Hangzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
The First Affiliated Hospital of Nanchang Medical University
Nanchang, Jiangxi
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Fudan University Zhongshan Hospital (General Surgery Department)
Shanghai, Shanghai Municipality
Fudan University Zhongshan Hospital (Internal Tumor Department)
Shanghai, Shanghai Municipality
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang
Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor
This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- CS3007 (BLU-285)
- 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.
CS3007 (BLU-285)Drug
A modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| CS3007(BLU-285) | Experimental | Not described Receives: Drug: CS3007 (BLU-285) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings
Measured: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures
Phase II: ORR based on mRESIST 1.1
Measured: At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Aug 2019
- Primary completion30 Apr 2020
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blueprint Medicines Corporation
- Responsible party
- Sponsor
- Investigators
- Lin SHEN, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254939
- Sponsor's protocol ID
- CS3007-101
- Status last verified
- Apr 2023
- First submitted
- 9 Dec 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Zhang X, Deng Y, Wu X, Zheng Z, Zhou Y, Cai S, Zhang Y, Zhang J, Tao K, Cui Y, Cao H, Shen K, Yu J, Zhou Y, Ren W, Qu C, Zhao W, Hu J, Wang W, Yang J, Shen L. Efficacy and Safety of Avapritinib in Treating Unresectable or Metastatic Gastrointestinal Stromal Tumors: A Phase I/II, Open-Label, Multicenter Study. Oncologist. 2023 Feb 8;28(2):187-e114. doi: 10.1093/oncolo/oyac242.
PubMed 36477870
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor
- ClinicalTrials.gov ID
- NCT04254939
- Acronym / sponsor ID
- CS3007-101
- Conditions
- Gastrointestinal Stromal Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Blueprint Medicines Corporation
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS3007(BLU-285) | Experimental | Drug: CS3007 (BLU-285) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene.
- For phase II study:
- Subjects with at least one measurable lesion as defined per mRECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Key exclusion criteria (14 listed)
- Subject has any of the laboratory results that meet exclusion criteria
- Subjects who have previously received antineoplastic medication, including Chinese herbal drugs or Chinese medicine products with antineoplastic indications, for less than 5 half-lives or 14 days, whichever is shorter, prior to the first dose of the investigational product.
- The subject received neutrophil growth factor support within 14 days prior to the first dose of investigational product.
- Subjects received treatment with a strong inhibitor or strong or moderate inducer of cytochrome P450 (CYP) 3A4 within 14 days prior to the first dose of study drug, or requires continuous intake of above medications or foods during study period.
- Subject received a major surgery (not including minor procedures, e.g., central venous catheterization, tumor needle biopsy, feeding tube placement) within 14 days prior to the first dose of investigational product.
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 |
|---|---|---|
| CS3007 (BLU-285)A modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days. | Drug | CS3007(BLU-285) |
Primary outcome
Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings
Time frame: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures
Phase II: ORR based on mRESIST 1.1
Time frame: At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months
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 27 Apr 2023.
- Derived from this study: PubMed 36477870Li J, Zhang X, Deng Y, Wu X, Zheng Z, Zhou Y, Cai S, Zhang Y, Zhang J, Tao K, Cui Y, Cao H, Shen K, Yu J, Zhou Y, Ren W, Qu C, Zhao W, Hu J, Wang W, Yang J, Shen L. Efficacy and Safety of Avapritinib in Treating Unresectable or Metastatic Gastrointestinal Stromal Tumors: A Phase I/II, Open-Label, Multicenter Study. Oncologist. 2023 Feb 8;28(2):187-e114. doi: 10.1093/oncolo/oyac242.
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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.
Lin SHEN, MD principal investigator
Peking University Cancer Hospital & Institute
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CS3007 (BLU-285) in people with Gastrointestinal Stromal Tumors, run by CStone Pharmaceuticals at 16 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 6 inclusion and 14 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings (time frame: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures). The study lists 2 primary outcomes in all. 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 NCT04254939, 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 27 Apr 2023.