AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 1/2NCT03888092

Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification

A Phase 1/2 study testing Z650 in people with Esophageal Squamous Cell Carcinoma, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Z650
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteChina
Study dates
18 Aug 2017to 13 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed Stage IIIB or IV ESCC
  • At least experienced one regimens of chemotherapy prior to study
  • Histological or cytological evidence of EGFR overexpression or gene copy number increased
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Show all 11Show fewer
  • Life expectancy of ≥ 12 weeks
  • Adequate organ function
  • Subject Consent
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to performing this study.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Prior treatments
  • EGFR targeted therapy, or major surgery within 4 weeks prior to study treatment
  • Nitrosourea and mitomycin chemotherapy within 6 weeks prior to study treatment
  • Had received any investigational agent from other clinical study within 4 weeks prior to study treatment or are currently participating in other clinical trials
  • Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction);
  • Symptomatic, untreated or unstable central nervous system metastases (patient are only permitted if treated, asymptomatic and stable for at least 4 weeks prior to start of study treatment)
Show all 18Show fewer
  • History of interstitial lung disease
  • Uncontrolled hypertension that require more than two anti-hypertensive agents to control, or systolic blood pressure (BP) >140mmHg or diastolic BP >90 mmHg before the first administration
  • Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%
  • Male with QTc interval > 450 ms or female with QTc interval > 470 ms
  • History of immunodeficiency, or other acquired or congenital immunodeficiency, or history of organ transplantation
  • Any disease of the following bellowed within 6 months prior to administration:
  • Myocardial infarction, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure, or cerebrovascular events (including transient ischemic attack)
  • Active infection of hepatitis B virus (HBV)/hepatitis C virus (HCV), or infection of Human immunodeficiency virus (HIV)
  • Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
  • History of serious allergic reactions attributed to excipients of Z650, including mannitol, sodium carboxymethyl starch, aerosol, magnesium stearate and silicified microcrystalline cellulose
  • Pregnant women, or patients not agree to use of effective contraceptions during the study or within 6 month after the study
  • Any other reason the investigator considers the patient is not suitable to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital, the Fifth Medical Center

    Beijing, Beijing Municipality, 100071

Other trials in China

About this study

Official title: A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma (ECSS) With Epidermal Growth Factor Receptor (EGFR) Over Expression or Gene Amplification

The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.

Read the detailed description

It is a multi-center , open-label, singer arm study to explore the safety and efficacy of Z650 in advanced ESCC patients who had experienced systematic chemotherapy. Approximately 45 subjects will be enrolled, each subjects will receive oral Z650, at dose of 350 mg/d, repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.

Being tested
Z650
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Z650Drug

    Also called Larotinib

    receive oral Z650 once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days

Study groups in NCT03888092
Study groupRoleWhat they receive
Z650 , Single-armExperimentalZ650 will be administered daily, at dose of 350 mg orally
Receives: Drug: Z650

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events (AEs) as a measure of safety and tolerability

    AEs assessment via monitoring changes in vital signs (e.g.body temperature, pulse rate, blood pressure, respiratory rate,etc.) and physical examinations(e.g.height, weight, BMI,etc.)

    Measured: up to 4 weeks after last dose

  2. Number of patients with adverse events (AEs) as a measure of safety and tolerability

    AEs assessment via monitoring changes in clinical laboratory parameters (e.g. levels of liver, kidney, and bone marrow function) and ECG (e.g. QTc Interval).

    Measured: up to 4 weeks after last dose

Secondary outcomes (5)

  1. Overall response rate (ORR)

    Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1

    Measured: up to approximately 24 months

  2. Disease Control Rate (DCR)

    DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)

    Measured: up to approximately 24 months

  3. Duration of Response (DOR)

    DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

    Measured: up to approximately 24 months

  4. Progression-free Survival (PFS)

    PFS, defined as time from date of treatment to disease progression or death due to any cause

    Measured: up to approximately 24 months

  5. Overall Survival (OS)

    OS, defined as time from date of treatment to death due to any cause

    Measured: up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start18 Aug 2017
  3. Primary completion13 Dec 2022
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888092
Sponsor's protocol ID
PCD-DZ650-17-001
Status last verified
May 2022
First submitted
18 Mar 2019
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu R, Liu L, Zhao C, Bai Y, Zheng Y, Zhang S, Li N, Yang J, Fan Q, Wang X, Zeng S, Zhang Y, Zhang W, Zhuang Y, Kang N, Jiang Y, Sun H, Xu J. Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study. BMC Gastroenterol. 2021 Oct 23;21(1):398. doi: 10.1186/s12876-021-01982-4.

    PubMed 34688250

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Z650 in people with Esophageal Squamous Cell Carcinoma, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (AEs) as a measure of safety and tolerability (time frame: up to 4 weeks after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888092, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in