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

NCT04282980 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ZL-2307-002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 9

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib

Outcome Measures

Primary Outcomes (1)

• 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).

  Approximately 10 months since the first subject enrolled.

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Approximately 15 months since the first subject enrolled.

• Overall Survival (OS)

  Approximately 28 months since the first subject enrolled.

• Time to Best Response (TBR)

  Approximately 15 months since the first subject enrolled.

• Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks

  Approximately 15 months since the first subject enrolled.

Study Arms (1)

DCC-2618

EXPERIMENTAL

DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.

Drug: DCC-2618

Interventions

DCC-2618 DRUG

Oral kinase inhibitor

Also known as: Ripretinib

DCC-2618

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead

Study Sites (9)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Location

Union Medical College Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Union Medical College Hospital, Fujian Medical University

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Zai Lab

Medinfo@zailaboratory.com

+86 4008201022

Study Officials

• Zai Lab

  Zai Lab (Shanghai) Co., Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: April 23, 2020
• Primary Completion: February 26, 2021
• Study Completion: August 23, 2022
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2024-12

Locations

CN (9)