A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

January 3, 2023 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Recruiting
        • the First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Jiang Hao
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincal Cancer Hospital
        • Contact:
          • Yifu He
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Yan Sun
      • Beijing, Beijing, China, 100021
        • Active, not recruiting
        • Cancer Hospital.Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Shaojun Lin
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Affiliated Hospital of Lanzhou University
        • Contact:
          • Juntao Ran
        • Contact:
          • Ting Wang
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Affiliated Cancer Hospital and institute of Guangzhou Medical University
        • Contact:
          • Weidong Li
    • Hebei
      • Shijiazhuang, Hebei, China, 50000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Tongsen Zheng
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Tumor Hospital
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Shundong Cang
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Xingya Li
    • Hubei
      • WuHan, Hubei, China, 430000
        • Recruiting
        • Union Hospital Toji Medical College Huazhong University of Science and Technology
        • Contact:
          • Kunyu Yang
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical College Of Hust
        • Contact:
          • Hu Guangyuan
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Zhenyang Liu
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Liaoyang Shen
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Tumor Hospital
        • Contact:
          • Cuihong Jiang
    • Jiangsu
      • Nantong, Jiangsu, China, 226361
        • Recruiting
        • Nantong Cancer Hospital
      • Wuxi, Jiangsu, China, 214122
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Yong Mao
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Jiujiang Cui
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
          • Bin Hu
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yufeng Cheng
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Provincial Institute of Cancer Prevention and Treatment
        • Contact:
          • Man Hu
      • Linyi, Shandong, China, 276000
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Jianhua Shi
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Zhongshan Hospital Affiliated to Fudan University
      • Shanghai, Shanghai, China, 20000
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
        • Contact:
          • Guipei Zhu
      • Shanghai, Shanghai, China, 200135
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Ye Guo
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi An JiaoTong University
        • Contact:
          • Shaoqiang Zhang
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Nianyong Chen
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Tumor Hospital
        • Contact:
          • Shichuan Zhang
      • Yibin, Sichuan, China, 644000
        • Recruiting
        • Second People's Hospital of Yibin City
        • Contact:
          • Kaijian Lei
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute＆Hospital
        • Contact:
          • Peiguo Wang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Minghua Ge
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Meiyu Fang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Shaoyifu Hospital of Zhejiang University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed the ICF and Age ≥ 18 years old, either sex.
  2. ECOG ≤ 1.
  3. Life expectancy of at least 3 months.
  4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
  5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
  6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.

Exclusion Criteria:

  1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
  2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
  3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICP-192
20 mg once daily
Drug: ICP-192
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
From the time of first dose until objective disease progression, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease
From the time of first dose until objective disease progression, an average of 6 months
Disease Control Rate (DCR)
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
From the time of first dose until objective disease progression, an average of 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.
From the time of first dose until objective disease progression, an average of 6 months
Overall survival (OS)
Time Frame: From the time of first dose until objective disease progression, an average of 1 year
OS is the time period from start of study medication untill death from any cause.
From the time of first dose until objective disease progression, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ye Guo, Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings