Clinical trial NCT04282980: A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 10 months since the first subject enrolled.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Approximately 15 months since the first subject enrolled.
measure: Overall Survival (OS)
timeFrame: Approximately 28 months since the first subject enrolled.
measure: Time to Best Response (TBR)
timeFrame: Approximately 15 months since the first subject enrolled.
measure: Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks
timeFrame: Approximately 15 months since the first subject enrolled.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
city: Chongqing
country: China
facility: Union Medical College Hospital, Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Union Medical College Hospital, Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Zai Lab (Shanghai) Co., Limited
name: Zai Lab
role: STUDY_DIRECTOR
References: