NCT04211922

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

December 23, 2019

Last Update Submit

April 25, 2024

Conditions

ALK-positive Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) based on independent radiology review

    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).

    24 months

Secondary Outcomes (2)

  • Progression-free survival (PFS) as assessed by independent radiology review and investigator

    36 months

  • Overall survival (OS)

    36 months

Study Arms (1)

Alkotinib 400mg QD

EXPERIMENTAL

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

Drug: Alkotinib Capsules

Interventions

Alkotinib CapsulesDRUG

Alkotinib 400mg QD

Also known as: ZG0418
Alkotinib 400mg QD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 lesion 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Officials

  • Caicun Zhou, Doctor

    Shanghai Pulmonary Hospital, Shanghai, China

    STUDY CHAIR

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

December 23, 2019

First Posted

December 26, 2019

Study Start

January 21, 2020

Primary Completion

October 11, 2022

Study Completion

October 11, 2022

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

CN(1)