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Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04211922
Collaborator
(none)
104
Enrollment
1
Location
1
Arm
31.3
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alkotinib Capsules
 Phase 2

Detailed Description

The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.

The study is a non-control study.

The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Actual Study Start Date :
Jan 20, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alkotinib 400mg QD

400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.

Drug: Alkotinib Capsules
Alkotinib 400mg QD
Other Names:
  • ZG0418

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) based on independent radiology review [24 months]

      ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

    Secondary Outcome Measures

    1. Progression-free survival (PFS) as assessed by independent radiology review and investigator [36 months]

      PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.

    2. Overall survival (OS) [36 months]

      OS, defined as time from first dose of Alkotinib to death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Evidence of positive ALK.

    • Patients must have demonstrated progression during or after crizotinib treatment.

    • Age 18 years or older at the time of informed consent.

    • Eastern cooperative oncology group performance status (ECOG PS) of 0-2

    • At least one measurable lension by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).

    • Willingness and ability to comply with the trial and follow-up procedures.

    Exclusion Criteria:

    • chemotherapy, radiation therapy, immunotherapy within 4 weeks.

    • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.

    • Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    Investigators

    • Study Chair: Caicun Zhou, Doctor, Shanghai Pulmonary Hospital, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT04211922
    Other Study ID Numbers:
    • ZGALK002
    First Posted:
    Dec 26, 2019
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 8, 2021