Gastrointestinal Stromal TumorsPhase 2NCT04282980
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
A Phase 2 study testing DCC-2618 in people with Gastrointestinal Stromal Tumors, run by Zai Lab (Shanghai) Co., Ltd. at 9 sites in China.
Trial summary
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. 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?
- DCC-2618
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 9 sitesChina
- Study dates
- 23 Apr 2020to 23 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients ≥18 years of age.
- Patients with advanced gastrointestinal stromal tumors.
- Subjects who have progressed or documented intolerance after previous treatments.
- Sign informed consent, understand the Protocol and could follow the Protocol.
- The subject had at least one measurable lesion.
- Adequate organ function and bone marrow reserve
Who cannot join
- Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- Prior treatment with DCC-2618.
- Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
- Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
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- Venous thrombotic events within 3 months before the first dose of investigational drug.
- 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval syndrome.
- Left ventricular ejection fraction (LVEF) <50% at screening.
- Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- Major surgeries within 4 weeks of the first dose of investigational drug.
- Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
- Active viral infections.
- If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
- Known allergy or hypersensitivity to any component of the investigational drug.
- Gastrointestinal abnormalities.
- Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality
West China Hospital of Sichuan University
Chengdu, Sichuan
Union Medical College Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality
Union Medical College Hospital, Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
Read the detailed description
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment.
The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- DCC-2618
- Keywords
- Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
- 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.
DCC-2618Drug
Also called Ripretinib
Oral kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| DCC-2618 | Experimental | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. Receives: Drug: DCC-2618 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).
Measured: Approximately 10 months since the first subject enrolled.
Secondary outcomes (4)
Objective Response Rate (ORR)
The objective response rate (ORR) is defined as the percentage of participants who achieved confirmed complete response (CR) or partial responses (PR) based on independent radiology review.
Measured: Approximately 15 months since the first subject enrolled.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.
Measured: Approximately 28 months since the first subject enrolled.
Time to Best Response (TBR)
Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response.
Measured: Approximately 15 months since the first subject enrolled.
Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks
Disease control rate (DCR) based on independent radiology review (confirmed CR + confirmed PR + SD for 12 weeks)
Measured: Approximately 15 months since the first subject enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start23 Apr 2020
- Primary completion26 Feb 2021
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zai Lab, Study director, Zai Lab (Shanghai) Co., Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282980
- Sponsor's protocol ID
- ZL-2307-002
- Status last verified
- Dec 2024
- First submitted
- 21 Feb 2020
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
- ClinicalTrials.gov ID
- NCT04282980
- Acronym / sponsor ID
- ZL-2307-002
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
Detailed description
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment.
The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCC-2618 | Experimental | Drug: DCC-2618DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients ≥18 years of age.
- Patients with advanced gastrointestinal stromal tumors.
- Subjects who have progressed or documented intolerance after previous treatments.
- Sign informed consent, understand the Protocol and could follow the Protocol.
- The subject had at least one measurable lesion.
Key exclusion criteria (17 listed)
- Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
- Prior treatment with DCC-2618.
- Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
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 |
|---|---|---|
| DCC-2618Also: RipretinibOral kinase inhibitor | Drug | DCC-2618 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Approximately 10 months since the first subject enrolled.
Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 15 months since the first subject enrolled.
Overall Survival (OS)
Time frame: Approximately 28 months since the first subject enrolled.
Time to Best Response (TBR)
Time frame: Approximately 15 months since the first subject enrolled.
Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks
Time frame: Approximately 15 months since the first subject enrolled.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zai Lab study director
Zai Lab (Shanghai) Co., Limited
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCC-2618 in people with Gastrointestinal Stromal Tumors, run by Zai Lab (Shanghai) Co., Ltd. at 9 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 17 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-Free Survival (PFS) (time frame: Approximately 10 months since the first subject enrolled.). 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 3 Mar 2025.