A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

December 20, 2012 updated by: Jiangsu HengRui Medicine Co., Ltd.
Henatinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Henatinib in patients with Advanced Solid Malignancies

Study Overview

Status

Status

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

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.

Detailed Description

  1. To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
  2. To determine the pharmacokinetic profile of Henatinib and its metabolites .
  3. To assess preliminary antitumor activity .
  4. To determine preliminary regimen for phase II study .

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 (Actual)

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.
44

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 1

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologic (except sputum smear) confirmed metastatic or locally advanced solid tumor (At least one measurable lesion longest diameter ≥20 mm using conventional techniques or larger than 10 mm in diameter by spiral CT scan).
  2. Life expectancy of more than 12 weeks.
  3. Lack of standard treatment or standard treatment failure.

  4. Screening laboratory values within the following parameters:

    1. HB:≥90g/L
    2. ANC:≥1.5×109/L
    3. PLT:≥100×109/L
  5. ALT and AST:≤1.5×ULN(But if the liver metastases, ALT and AST:≤5×ULN) 1. Serum total bilirubin:≤1.5×ULN 2. Serum creatinine:≤1.5×ULN 3. Creatinie clearance rate:≥60ml/min 4. Electrolytes normal or return to normal after treatment
  6. Recovery from all clinically significant AEs related to prior therapies. Duration from the latest therapy is more than 6 weeks for nitroso or mitomycin, or more than 4 weeks for radiotherapy, chemotherapy, immunotherapy or other anti-cancer treatments (such as testing drugs, biologics, hormones or surgery).
  7. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

  1. Evidence of CNS metastasis.
  2. Major surgery, open biopsy, or obvious trauma within 4 weeks before treatment.
  3. Obvious peritoneal implantation or pelvic obstruction.
  4. II level or above, peripheral neuropathy (NCI CTC AE v3.0).
  5. Known history of neurological or psychiatric disease.
  6. Suffering from high blood pressure and can not be reduced to the following range by monotherapy (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg).
  7. History of heart disease:> NYHA II class congestive heart failure; unstable coronary artery disease (patients who had last myocardial infarction 12 months before can be enrolled), arrhythmias - requires antiarrhythmic drug therapy. Bazett's corrected QTc ≥ 480 ms or can not be measured. (Note: If ECG QTc interval ≥ 480 ms during the screening period, you must repeat 2 times, separated by at least 24 hours, the average QTc of the 3 times must be <480 s, the patient can be enrolled in this study) .
  8. Coagulopathy (PT> 16 s, APTT> 43 s, TT> 21 s, Fbg <2 g / L), with a bleeding tendency or are receiving the therapy of thrombolysis or anticoagulation.
  9. Confirmed active gastrointestinal ulcers.
  10. Active severe infection (> NCI-CTC 3.0 standard 2).
  11. Patients with severe epilepsy requires drug treatment (such as steroids or anti-epileptic drugs).
  12. Other serious illness or condition.
  13. Treated with VEGFR TKIs such as sunitinib or solafenib before study entry.
  14. Less than 4 weeks from the last clinical trial.
  15. Pregnancy, breast-feeding women or women of childbearing age without effective contraception.
  16. Allergic or known history of hypersensitivity to henatinib or any of it components.
  17. Drug abuse, the drug and mental illness may affect the patients participation in this study and the assessment of the research results.
  18. Any unstable or likely situation that harms the safety and compliance of the patients in this study.
  19. Any factors that influence the usage of oral administration.
  20. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Henatinib
Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily
Drug: henatinib
Henatinib Maleate Tablets

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
Time Frame
The maximum-tolerated dose (MTD) regimen of henatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.
Time Frame: 4 weeks
4 weeks

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
Time Frame
Number of participants with adverse events
Time Frame: 8 weeks
8 weeks
Henatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Time Frame: 4 weeks
4 weeks
Objective response rate (ORR)
Time Frame: 8 weeks
8 weeks

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.
Jiangsu HengRui Medicine 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: jin Li, Dr, Fudan University

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

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.
September 1, 2010

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 1, 2012

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.
December 1, 2012

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).
August 12, 2011

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.
August 12, 2011

First Posted (ESTIMATE)

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.
August 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

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.
December 21, 2012

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.
December 20, 2012

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, 2012

More Information

Terms related to this study

Keywords

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.
  • HNTN-I

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.

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