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Advanced or Metastatic Solid TumorsPhase 1NCT02004548

Phase I Clinical Study of Metatinib Tromethamine Tablet

A Phase 1 study testing Metatinib Tromethamine in people with Advanced or Metastatic Solid Tumors, run by Jiangsu Simcere Pharmaceutical 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
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Trial summary

Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
Metatinib Tromethamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
May 2013to Dec 2015
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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18~24 kg/m^2, including the boundary values;
  • The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival;
  • Not treated with standard therapeutical regime currently, or has progressed or relapsed after standard treatment;
  • Time from last cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (immune modulators, cytokines) ≥ 4 weeks, or nitrosoureas or mitomycin C ≥ 6 weeks. If having received an antibody anti-tumor biological product, at least 8-week washout period is required;
  • At least 4 weeks after surgery, and the wound must be healed completely;
  • If subject has chemotherapy-induced toxicity, the adverse events must be recovered to ≤ grade 1 (NCI-CTC version 4.0) except for alopecia;
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  • ECOG performance status of 0-2;
  • Expected survival time is more than three months;
  • The subject has organ and marrow function as follows:
  • absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L,
  • platelets ≥ 80 x 10^9/L,
  • hemoglobin ≥ 90 g/L (blood transfusion is allowed),
  • total bilirubin ≤ 2 x ULN (<3 x ULN with liver metastases),
  • serum creatinine ≤ 150 μmol/L or calculated creatinine clearance ≥ 60 mL/min,
  • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (<5 x ULN with liver metastases),
  • uric acid <500 μmol/L,
  • proteinuria ≤ 2 + or ≤ 2g / 24h;
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document;

Who cannot join

  • The subject is known to be positive for the human immunodeficiency virus (HIV);
  • The subject is known to be positive for hepatitis B surface antigen or hepatitis C;
  • Previous participation in other clinical trials within three months before study;
  • Concomitant chemotherapy, hormone therapy, immunotherapy program or radiotherapy;
  • The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
  • The subject has psychiatric illness/social situations that would limit compliance with study requirements;
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  • The subject has brain metastases;
  • Imaging study showed involvement of major blood vessels or nerves by tumor;
  • Uncontrollable hypertension (referring to systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg after treatment) or LVEF <50%;
  • Patient with disease history of bleeding or thromboembolic events occurred within the past six months and need for preventive anticoagulant therapy;
  • Patient needs surgery within 28 days, or is expected to require surgery within 28 days after the last dose administration;
  • Significant abnormality in the important organs, such as heart, lung, liver, kidney;
  • Has third lacunar effusion with difficulty to control;
  • The subject is pregnant or breastfeeding;
  • Sexually active subjects (male and female) refuse to use medically acceptable methods of contraception during the course of the study and for 1 month following discontinuation of study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors

Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters.

Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.

Being tested
Metatinib Tromethamine

What participants receive

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

  • Metatinib TromethamineDrug

Study groups in NCT02004548
Study groupRoleWhat they receive
Metatinib TromethamineExperimentalDose escalation is in accordance with the traditional "3 +3" design, and dose groups are subsequently set as: 25, 50, 100, 200, 300, 450, 600, 800 mg/d.
Receives: Drug: Metatinib Tromethamine

What is being measured

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

  1. Dose-limiting Toxicity (DLT)

    Measured: up to day 32

  2. Maximum Tolerated Dose (MTD)

    Measured: up to day 32

Secondary outcomes (3)

  1. Cmax

    Measured: d1、d2、d3、d8、d15、d22、d29、d30、d31

  2. AUC

    Measured: d1、d2、d3、d8、d15、d22、d29、d30、d31

  3. Objective response rate (ORR)

    Measured: week 4, week 10, week 16

Timeline

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

  1. First posted9 Dec 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2015
  4. Study completionDec 2015

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004548
Sponsor's protocol ID
SIM-89-1
Status last verified
Nov 2015
First submitted
26 Nov 2013
Last updated
29 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Tabouret E, Fabbro M, Autran D, Hoang-Xuan K, Taillandier L, Ducray F, Barrie M, Sanson M, Kerr C, Cartalat-Carel S, Loundou A, Guillevin R, Mokhtari K, Figarella-Branger D, Delattre JY, Chinot O. TEMOBIC: Phase II Trial of Neoadjuvant Chemotherapy for Unresectable Anaplastic Gliomas: An ANOCEF Study. Oncologist. 2021 Aug;26(8):647-e1304. doi: 10.1002/onco.13765. Epub 2021 Apr 20.

    PubMed 33783067

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metatinib Tromethamine in people with Advanced or Metastatic Solid Tumors, run by Jiangsu Simcere 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 18 inclusion and 15 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 29 Dec 2015. 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 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?

Dose-limiting Toxicity (DLT) (time frame: up to day 32). 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 NCT02004548, 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 29 Dec 2015.

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