MedDataX Logo

A Study of Olverembatinib in SDH-deficient GIST.

NCT ID: NCT06640361

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

GIST

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Olverembatinib GIST

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Olverembatinib

Group Type EXPERIMENTAL

Olverembatinib

Intervention Type DRUG

Oral administration with meal, QOD, every 28 days for a cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olverembatinib

Oral administration with meal, QOD, every 28 days for a cycle.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.
2. Must have at least one measurable target lesion.
3. ECOG≤ 2.
4. Expected survival of at least 3 months.
5. Adequate organ function.
6. Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.
7. Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.
8. Prior to initiation of any screening or study-specific procedures, the patient or his/her guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.

Exclusion Criteria

1. Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.
2. Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
3. Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
4. Adverse events due to prior treatment have not recovered (\> NCI CTCAE v5.0 Grade 1).
5. Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
6. With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.
7. Poorly controlled hypertension after hypertension medication.
8. Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.
9. Uncontrolled Hyperlipidemia.
10. Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.
11. With brain metastases.
12. Other malignancies within 2 years.
13. Uncontrolled systemic active fungal, bacterial, and/or viral infections.
14. Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.
15. Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HealthQuest Pharma Inc.

INDUSTRY

Sponsor Role collaborator

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruihua Xu, M.D., Ph.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yifan Zhai, M.D., Ph.D.

Role: CONTACT

Phone: +86-20-28068501

Email: [email protected]

Chen Yang, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ruihua Xu, M.D.,Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HQP1351GG301

Identifier Type: -

Identifier Source: org_study_id