- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01416623
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
Detailed Description
- To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- To determine the pharmacokinetic profile of Henatinib and its metabolites .
- To assess preliminary antitumor activity .
- To determine preliminary regimen for phase II study .
Study Type
Interventional
Enrollment (Actual)
44
Phase
- 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
-
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Shanghai
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Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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-
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
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- Life expectancy of more than 12 weeks.
- Lack of standard treatment or standard treatment failure.
Screening laboratory values within the following parameters:
- HB:≥90g/L
- ANC:≥1.5×109/L
- PLT:≥100×109/L
- 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
- 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).
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion Criteria:
- Evidence of CNS metastasis.
- Major surgery, open biopsy, or obvious trauma within 4 weeks before treatment.
- Obvious peritoneal implantation or pelvic obstruction.
- II level or above, peripheral neuropathy (NCI CTC AE v3.0).
- Known history of neurological or psychiatric disease.
- 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).
- 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) .
- 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.
- Confirmed active gastrointestinal ulcers.
- Active severe infection (> NCI-CTC 3.0 standard 2).
- Patients with severe epilepsy requires drug treatment (such as steroids or anti-epileptic drugs).
- Other serious illness or condition.
- Treated with VEGFR TKIs such as sunitinib or solafenib before study entry.
- Less than 4 weeks from the last clinical trial.
- Pregnancy, breast-feeding women or women of childbearing age without effective contraception.
- Allergic or known history of hypersensitivity to henatinib or any of it components.
- Drug abuse, the drug and mental illness may affect the patients participation in this study and the assessment of the research results.
- Any unstable or likely situation that harms the safety and compliance of the patients in this study.
- Any factors that influence the usage of oral administration.
- 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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Henatinib
Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily
|
Henatinib Maleate Tablets
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What is the study measuring?
Primary Outcome Measures
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
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Secondary Outcome Measures
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
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4 weeks
|
Objective response rate (ORR)
Time Frame: 8 weeks
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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
September 1, 2010
Primary Completion (ANTICIPATED)
December 1, 2012
Study Completion (ANTICIPATED)
December 1, 2012
Study Registration Dates
First Submitted
August 12, 2011
First Submitted That Met QC Criteria
August 12, 2011
First Posted (ESTIMATE)
August 15, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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