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Neoplasms，Non-Small Cell Lung CancerPhase 1NCT02467569

Study Evaluating Hemay020 In Subjects With Advanced Solid Cancer

A Phase 1 study testing Hemay020 in people with Neoplasms，Non-Small Cell Lung Cancer, run by Tianjin Hemay Pharmaceutical Co., Ltd at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the pharmacokinetics，safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neoplasms，Non-Small Cell Lung Cancer
What is being tested?
Hemay020
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
3 Jul 2015to 31 Dec 2017
Phase
Phase 1
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 to 70 years;
  • Subjects with histologically or cytologically confirmed diagnosis of solid tumor; and subjects who have failed standard therapy，or no effective therapy available for such patients;
  • at least one measurable tumour lesion (non radiation field) as defined by RECIST criteria and measured by CT or MRI techniques;
  • Patients have received chemotherapy at least 4 weeks prior to screening and must have recovered from any toxic effects of the treatment to CTCAE≤Grade 1;
  • Part 1 Only: ECOG Performance Status of 0,1;
  • Life expectancy of at least three (3) months;
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  • Adequate bone marrow, liver, kidney and coagulation function, meeting the following criteria:
  • ANC≥1.5×109/L，HB≥90g/L，PLT≥75×109/L； TBIL≤2×ULN； ALT≤2.5×ULN，AST≤2.5×ULN（ALT≤5×ULN，AST≤5×ULN if liver metastases are present） Serum creatinine≤1.5×ULN INR≤1.5×ULN Patients without gastrointestinal tract disease, which results in malabsorption syndrome, or patients who are unable to take oral medication;
  • All female and male subjects must agree and commit to the use of two contraceptive regimen for the duration of the study and for 6 months after the last dose of test article. Female subjects must have a negative serum or urine pregnancy test performed within 72 hours prior to treatment. Male subjects's sexual partner must use two contraceptive regimen.
  • Two contraceptive regimens include a medication and non-medication contraceptive regimen;
  • Able to understand and sign a written informed consent before study entry;
  • Histological or cytological diagnosis of EGFR wild-type (or genetype is not determined) patients, with advanced or metastatic lung cancer after receiving two chemotherapy; or advanced or metastatic patients with EGFR mutation after receiving EGFR-TKI and one chemotherapy.
  • ECOG Performance Status of 0,1,2

Who cannot join

  • Patients with parenteral nutrition; malabsorption syndrome; any condition possibly affecting drug absorption or inability to tolerate oral medications;
  • Immunodeficiency history, including human immunodeficiency HIV positive（by ELISA and Western Blot）;
  • clinically QTc prolongation, ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure, symptoms requiring medicine treatment patients with coronary heart disease;
  • Left ventricular ejection fraction (LVEF) <40％;
  • active infection (ie, requiring intravenous antibiotic or antiviral agent);
  • Organ or system status:
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  • Patients with brain metastasis untreated surgical resection or radiotherapy, Patients with treated brain metastasis may be excluded if they are neurologically unstable and have been on steroids or receiving steroids less than 4 weeks prior to study;
  • Patients with bone marrow metastasis;
  • Documented history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis with steroids treatment, any evidence of clinically active interstitial lung disease;
  • Idiopathic fibrosis of the lung by CT scan before study entry;
  • Presence of clinically significant or uncontrolled disease (ie. unstable or uncompensated respiratory, heart, liver, kidney disease) in the investigator's judgment;
  • Any unstable systemic disease(including severe hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic disease)
  • Any other malignant cancer within 5 years with the exception of adequately treated cervical cancer in situ or basal and squamous cutaneous cell carcinomas
  • Neurological and psychogenic disorders, including epilepsia or dementia;
  • Major surgery (not including biopsy) or injury within 4 weeks of treatment day 1;
  • History of alcohol or drug abuse;
  • Women who are pregnant or breast feeding or plan to be pregnant;
  • Pulse rate<40 per minute or >120 per minute; systolic pressure>140mmHg or diastolic pressure>90mmHg; axillaty temperature ≥37.1℃ or oral temperature ≥37.3℃;
  • Have a known hypersensitivity to the test article or any of the excipient of the test article;
  • Have received other clinical trials treatment within the last 3 months or at the time of study;
  • History of herbal ingredient, depressant, hypnotic or other drug abuse;
  • Evidence of significant medical illness or abnormal laboratory finding that would make the subject inappropriate for this study in by the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Phase I Trial Evaluating Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay020 in Patients With Advanced Solid Cancer

The purpose of this study is to assess the pharmacokinetics，safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the trial to better define the tolerability and preliminary efficacy of Hemay020.

Read the detailed description

This is a phaseⅠsequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will receive a single dose of Hemay020, followed by a 2-week observation period, and then will receive Hemay020 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of two dose groups administered to subjects with NSCLC.

Being tested
Hemay020

What participants receive

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

  • Hemay020Drug

Study groups in NCT02467569
Study groupRoleWhat they receive
Hemay020ExperimentalPart one: Dose Escalation Group Hemay020 capsules will be taken orally in doses of 25mg, 50mg, 100mg, 200mg or 300mg once daily for 28 days. Part two: Extension Group Hemay020 capsules will be taken in two dose groups that assessed by Part one for 28 days.
Receives: Drug: Hemay020

What is being measured

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

  1. Number of participants with adverse events

    Measured: At screening, weekly up to 18 months

  2. Observed maximum concentration of Hemay020

    Measured: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42

  3. Time of maximum concentration of Hemay020

    Measured: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42

  4. Area under the plasma concentration versus time curve of Hemay020

    Measured: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42

  5. Trough Plasma Concentrations of Hemay020

    Measured: 0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 hours post-dose on day 1 and day 42

  6. Predose plasma concentration

    Measured: Predose on day 8, 15, 22]

Secondary outcomes (2)

  1. Disease control rate (complete response rate + partial response rate + stable disease rate) according to RECIST v1.1

    Measured: At screening, after 4 weeks of treatment

  2. Objective response rate (complete response rate + partial response rate) according to RECIST v1.1

    Measured: At screening, after 4 weeks of treatment

Timeline

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

  1. First posted10 Jun 2015 (estimated)
  2. Study start3 Jul 2015
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467569
Sponsor's protocol ID
Hemay020P1 2014
Status last verified
Feb 2024
First submitted
2 Jun 2015
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hemay020 in people with Neoplasms，Non-Small Cell Lung Cancer, run by Tianjin Hemay Pharmaceutical 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 13 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 Mar 2024. 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 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.

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 was stopped early. Results are not available in the source record.

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 participants with adverse events (time frame: At screening, weekly up to 18 months). The study lists 6 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 NCT02467569.

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 1 Mar 2024.

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