A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282980
• Other study ID #: ZL-2307-002
• Status: Completed
• Phase: Phase 2
• Start date: April 23, 2020
• Est. completion date: August 23, 2022

Study information

• Verified date: August 2022
• Source: Zai Lab (Hong Kong), Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 23, 2022
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• DCC-2618
Oral kinase inhibitor

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Chinese People's Liberation Army General Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Union Medical College Hospital, Chongqing Medical University	Chongqing	Chongqing
China	Union Medical College Hospital, Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zai Lab (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival(PFS) based on independent imaging review	Progression-Free Survival(PFS) is defined as the time from the first dose of study drug to the first documentation of disease progression based on independent radiology review or death due to any cause (whichever occurred first) .	Approximately 24 months since the first subject enrolled
Secondary	Objective Response Rate(ORR) based on independent imaging review	Objective Response Rate(ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on independent radiology review.	Approximately 24 months since the first subject enrolled
Secondary	Overall survival (OS)	Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.	Approximately 24 months since the first subject enrolled
Secondary	Time to Best Response(TBR) based on independent radiology review	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.	Approximately 24 months since the first subject enrolled
Secondary	Progression-Free Survival(PFS) assessment by investigators	Progression-Free Survival(PFS) assessed by investigators is defined as the duration from the first dose of study drug to the first documentation of disease progression by the investigator or all-cause death (whichever occurs first)	Approximately 24 months since the first subject enrolled
Secondary	Disease Control Rate(DCR)	Disease control will be defined as complete response or partial responses or stable disease.	12 Weeks