Advanced Solid CancerPhase 1NCT01416623
A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
A Phase 1 study testing henatinib in people with Advanced Solid Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Cancer
- What is being tested?
- henatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2012
- 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
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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
Read the 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 .
- Conditions
- Advanced Solid Cancer
- Being tested
- henatinib
- Keywords
- Advanced solid cancer, Henatinib, phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
henatinibDrug
Henatinib Maleate Tablets
| Study group | Role | What they receive |
|---|---|---|
| Henatinib | Experimental | Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily Receives: Drug: henatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Number of participants with adverse events
Measured: 8 weeks
Henatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Measured: 4 weeks
Objective response rate (ORR)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jin Li, Dr, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416623
- Sponsor's protocol ID
- HNTN-I
- Status last verified
- Dec 2012
- First submitted
- 12 Aug 2011
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01416623
- Acronym / sponsor ID
- HNTN-I
- Conditions
- Advanced Solid Cancer
- Keywords
- Advanced solid cancer, Henatinib, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Henatinib | Experimental | Drug: henatinibHenatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| henatinibHenatinib Maleate Tablets | Drug | Henatinib |
Primary outcome
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
3 secondary outcomes
Number of participants with adverse events
Time frame: 8 weeks
Henatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Time frame: 4 weeks
Objective response rate (ORR)
Time frame: 8 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
Related trials for Advanced Solid Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jin Li, Dr principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing henatinib in people with Advanced Solid Cancer, run by Jiangsu HengRui Medicine 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 10 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: stopped early, as of the sponsor's last update on 21 Dec 2012. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2012.