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Advanced or Metastatic Gastric CancerPhase 1NCT02650375

Study of Metatinib Tromethamine Tablet

A Phase 1 study testing Metatinib Tromethamine in people with Advanced or Metastatic Gastric Cancer and Advanced or Metastatic Liver Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Metatinib Tromethamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesChina
Study dates
Oct 2015to Feb 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced or metastatic gastric cancer or colorectal cancer who progress after second-line therapy or the above treatment protocol, or patients with advanced or metastatic hepatocellular carcinoma who progress after first-line chemotherapy, interventional therapy or targeted therapy shall be verified by histology or cytology; or patients with advanced or metastatic non-squamous non-small cell lung cancer who cannot be operated or fail to first-line therapy shall be verified by histology or cytology;
  • MET gene amplification or protein overexpression(IHC ≥2+）,or exon-14 skipping;
  • At least one measurable lesion (RECIST 1.1 );
  • At least 4 weeks from the last chemotherapy, radiotherapy or anti-tumor biological products treatment; at least 8 weeks from the last anti-tumor antibody products treatment; at least 6 weeks from the last dose of nitrosourea, mitomycin C or doxorubicin;
  • At least 4 weeks from major surgery or trauma, and the wound should fully heal; at least 1 week from minor surgery or trauma (i.e. tissue biopsy or fine needle aspiration);
  • Toxicity from previous treatment has to restore to ≤ grade 1, baseline or irreversible (NCI CTC4.0);
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  • ECOG performance status 0-1;
  • Life expectancy ≥3 months;
  • Adequate hematologic function: ANC≥1.5×10^9 /L, HB≥90g/L(blood transfusion allowed), PLT≥100×10^9/L;
  • Adequate hepatic function: ALT≤3×ULN, AST≤3×ULN, TBIL≤2×ULN(patients with liver metastases or liver cancer ALT≤5×ULN, AST≤5×ULN, TBIL≤2×ULN), Child-Pugh score≤7;
  • Adequate renal function: uric acid<500μmol/L, creatinine<1.7mg/dL, proteinuria≤2＋or≤2g/24h , GFR≥60 ml/min/1.73m^2;
  • PT-INR/APTT≤1.5×ULN, Serum sodium, potassium, calcium, magnesium levels ≤1×ULN(NCI-CTC 4.0);
  • Patients signed written informed consent;
  • Willingness and capability to comply with protocol requirement and well communicate with investigators.

Who cannot join

  • Severe, uncontrolled medical disorders or active infection, including but not limited to HIV antibody positive, active tuberculosis, HBV DNA copies>10^3/ml;
  • Subjects have known or suspected brain metastases;
  • Patients must receive other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for palliative local radiation) or traditional Chinese medicine for treatment of cancer during the study;
  • Previously received other VEGF/VEGFR small-molecule inhibitors or antibodies therapy, including but not limited to Bevacizumab, Ramucirumab, Aflibercept;
  • Previously received other HGF/c-Met small-molecule inhibitors or antibodies therapy, including but not limited to Crizotinib, Cabozantinib, Volitinib, Capmatinib (INC280), BPI-9016M;
  • Imaging showed involvement of major blood vessels or nerves by tumor;
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  • Uncontrolled hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>100mmHg after treatment);
  • LVEF<50%;
  • Apparent heart disease, including congestive heart failure(NYHA III-IV), history of myocardial infarction, or uncontrolled angina within 6 months prior to enrollment;
  • Arrhythmias need to be treated, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or ventricular fibrillation; ECG abnormalities confirmed, including QT interval prolongation (males>450msec, females>470 msec);
  • History of hemorrhagic or thrombotic events within 6 months before enrollment, i.e. cerebrovascular accidents(including TIA), pulmonary embolism, spontaneous hemorrhage of tumor;
  • Patients need surgery within 28 days, or is expected to require surgery within 28 days after the last dose;
  • Uncontrolled cavity effusion, such as large amount of pleural effusion and ascites;
  • Gastrointestinal illnesses(i.e., uncontrolled diarrhea or malabsorption) at screening or within 3 months that may affect drug absorption;
  • History or suspicious signs of gastrointestinal perforation;
  • Concomitant medications that may affect the drug metabolism (i.e. strong CYP3A4 inhibitors or inducer );
  • Pregnant or lactating women;
  • Subjects of childbearing refused to use medically acceptable methods of contraception until 3 months after the last dose;
  • Participate in other clinical trials within 4 weeks prior to enrollment;
  • The investigators consider the patients are not suitable for this trial

Trial locations and contacts

3 sites in 1 country.

Shuangling Deng, MS contact

86-025-85560000

dengshuangling@simcere.com

China3 sites, 3 recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Yanhua Ding, MD

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Feng Bi, MD

    Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Clinical Study of the Tolerance, Safety and Preliminary Efficacy Observation of Single-/Multiple- Doses of Metatinib Tromethamine Tablets in Patients With Advanced or Metastatic Solid Tumor

This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC. Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. The study will determine whether MET gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will also be explored.

Being tested
Metatinib Tromethamine
Medical subject headings
Stomach Neoplasms, Liver Neoplasms

What participants receive

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

  • Metatinib TromethamineDrug

    Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.

Study groups in NCT02650375
Study groupRoleWhat they receive
Metatinib TromethamineExperimentalNot described
Receives: Drug: Metatinib Tromethamine

What is being measured

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

  1. incidence of adverse events

    Measured: until 30 days after the last dose

Secondary outcomes (10)

  1. Objective response rate

    Measured: every 6 weeks, up to 2 years

  2. Disease control rate

    Measured: every 6 weeks, up to 2 years

  3. Progression free survival

    Measured: every 6 weeks, up to 2 years

  4. Overall survival

    Measured: every 6 weeks, up to 2 years

  5. Cmax for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

  6. Cmin for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

  7. Tmax for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

  8. AUC for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

  9. T1/2 for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

  10. CL for Metatinib

    Measured: day 1,day 2,day 8,day15,day22

Timeline

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

  1. First posted8 Jan 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2017 (estimated)
  4. Study completionFeb 2018 (estimated)

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650375
Sponsor's protocol ID
SIM-128-I-02
Status last verified
Jan 2017
First submitted
10 Nov 2015
Last updated
23 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metatinib Tromethamine in people with Advanced or Metastatic Gastric Cancer and Advanced or Metastatic Liver Cancer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 3 sites 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 14 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Contact Shuangling Deng, MS (86-025-85560000, dengshuangling@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of adverse events (time frame: until 30 days after the last dose). 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 NCT02650375.

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 23 Jan 2017.

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