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Advanced CancerPhase 1HS:Hansoh;NCT03243643

Tolerability, Safety, Pharmacokinetics and Efficacy of HS-10241 Single Agent or Combined With Apatinib in Patients With Advanced Solid Tumors

A Phase 1 study testing HS-10241 and Apatinib in people with Advanced Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To investigate tolerability, safety, pharmacokinetics and efficacy of C-met Kinase Inhibitor HS-10241 single agent or combined with Apatinib in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Cancer
What is being tested?
HS-10241 and Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
8 Aug 2017to Dec 2019
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

  • 18-75 years of age.
  • Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed.；For part 2 (Expansion part) c-met immunohistochemistry (IHC) positive（IHC++ or IHC+++）and with at least one measurable disease according to RECIST 1.1.
  • No difficulty that may hamper compliance and/or absorption of the tested product (swallowing difficulty, chronic gastrointestinal disease like diarrhea and intestinal obstruction )
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0～1.
  • Life expectancy of at least 3 months.
  • Adequate organ function:（No blood transfusion or hematopoietic stimulating factor within 14days of screening stage）：
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  • Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:：Absolute neutrophil count (ANC) ≥1500/μL
  • Platelet count ≥90000/μL,，Hemoglobin ≥9.0 g/dL
  • Acceptable liver function defined below:：Total bilirubin ≤ 1.5 times upper limit of normal range (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN; however, ≤5 times ULN in a subject who has liver metastases.
  • Acceptable renal function defined below:：Serum creatinine ≤1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥60 mL/minutes.
  • Acceptable cardiac function defined below:： left ventricular ejection fraction，LVEF≥50% ；normal ECG，QTc male<450ms，female<470ms
  • Recovered from toxicities of prior anti-cancer treatment (NCI-CTCAE 4.03≤ grade 1, except alopecia); Proper period of wash out of previous treatment (at least 5 half-life wash out), e.g. No nitrosoureas or mitomycin within 6 weeks，no cytotoxic drugs, monoclonal antibodies, radiation therapy, or surgery within 4 weeks and no endocrine therapy or tyrosine kinase inhibitors (TKIs) within 2 weeks before first dose of the tested product.
  • Non-surgical sterilization or post-menopause female must agree to use effective means of contraception (IUD , medication or condom ) during and 8 weeks after the clinical trial.Human Chorionic Gonadotropin ( HCG ) serum test must be negative tested 7 days before the first dose of tested product and not being in the lactation period. For male subjects whose female partners have childbearing potential must be surgical sterilization or agree to use effective means of contraception during and 120 days after the clinical trial.
  • Tumor tissue sample available or agree to provide biopsies for testing.
  • Volunteer to participate in the clinical trial, understand the procedure of trial and approved informed consent obtained before entering the trial.

Who cannot join

  • Failed in previous c-met or VEGFR inhibitor treatment;
  • Participation in other clinical trial or the last dose of the other trail was taken within 4 weeks.
  • Other anti-cancer treatment might be received during the trial leading to pause of the trial.
  • Tumor infiltration of the vessel, tumor cavity or necrosis with risk of hemorrhage.
  • Central nervous system (CNS) metastases or meningeal metastases or primary nervous system tumor untreated by surgery or radiotherapy.
  • Patients with clinical symptoms of ascites or pleural effusion, need therapeutic puncture and drainage.
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  • Uncontrolled chronic systematic complications (such as chronic pulmonary , hepatic, renal or cardiac diseases).
  • Grade II myocardial ischemia or myocardial infarction or uncontrolled arrhythmia. Cardiac dysfunction with New York Heart Association (NYHA) Class III or IV.
  • Hypertension and unable to be controlled within normal level following treatment of two anti-hypertension agents (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
  • Urine protein≥ ++，or 24 hour urine protein≥1.0 g；
  • Patients with or previous with clinically significant hemorrhage within 3 months, with hemorrhage risk or being in anticoagulant and fibrinolytic treatment like gastrointestinal bleeding , hemorrhagic ulcers, baseline defecate occult blood positive and above or vasculitis. Abnormal coagulant function such as INR(international normalized ratio)>1.5 or PT （Prothrombin Time）>ULN+4 seconds）.
  • Arterial or venous thromboembolism events within 6 months，like cerebral vascular accident (transient ischemic attack, cerebral hemorrhage or cerebral infarction) or deep venous thrombosis and pulmonary embolism.
  • Active infection needed for treatment.
  • HIV,HBV (Hepatitis B Virus), HCV (Hepatitis C Virus) positive（HBV：HBsAg positive with hepatic function abnormality and HBV-DNA≧104 copy/mL，HCV：HCV-RNA positive with hepatic function abnormality）needed for antivirus treatment（only for Part 1）.
  • History of mental or neurological disorders.
  • Psychiatric drug abuse history or addiction history
  • Unable to complete the trial or withdraw in the middle of the trial due to conditions like psychological state, family relationship, social or geographical factors or with concomitant treatment or abnormal laboratory examinations judging by the investigator.
  • Concomitant diseases ( uncontrolled hypertension , severe diabetes and thyroid disease ) deemed by the investigator to be likely to interfere with the subjects safety or leads to discontinuation from the trial.

Trial locations and contacts

1 site in 1 country.

Yi Li, Ph.D contact

021-68868570

liuy@shhrp.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chendu

    Feng Bi, Ph.D, 028-85423203, bifeng@medmail.com.cn

    Recruiting

Other trials in China

About this study

To investigate tolerability, safety, pharmacokinetics and efficacy of C-met Kinase Inhibitor HS-10241 single agent or combined with Apatinib in Subjects With Advanced Solid Tumours that are not eligible for conventional or intensive treatment. The dose of HS-10241 will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of HS-10241 single agent and in combination with Apatinib in advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 or combined with Apatinb will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.

Conditions
Advanced Cancer
Being tested
HS-10241, Apatinib

What participants receive

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

  • HS-10241Drug

    Also called c-met inhibitor

    HS-10241 is provided as white, film-coated,immediate release tablets containing HS-10241 at dosage strengths of 20mg/50mg/100 mg. Multiple tablets of HS-10241 will be administered daily to achieve targeted doses of HS-10241: 200 mg-1200 mg. Tablets will be orally administered with 240 ml water, once daily, 1 hour before/after a meal.

  • ApatinibDrug

    Apatinib is provided as white, film-coated,immediate release tablets containing aptinib at dosage strengths of 250mg. Apatinib will be administered daily to achieve targeted doses of 500 mg. Tablets will be orally administered with 240 ml water, once daily, 1 hour before/after a meal.

Study groups in NCT03243643
Study groupRoleWhat they receive
HS-1024+apatinibExperimentalFor part 1 (PK study) subjects will be given single dose of HS-10241 and then multiple dose of HS-10241 (1 cycle, each cycle 14days) and then HS-10241+aptatinib (each cycle 21 days) until PD. For part 2 (expansion study) subjects will be given HS-10241+aptatinib (each cycle 21 days) until PD (Progression of disease).
Receives: Drug: HS-10241; Drug: Apatinib

What is being measured

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

  1. Dose Limiting Toxicities (DLT)

    To assess MTD and DLT of HS-10241 single agent（D1-D17） then combined with aptatinib （D18-D38） in patients with advanced solid tumors.According to the "3+3" dose escalation design DLT will be determined.

    Measured: Day1 to day 38 (DLT observation period)

  2. Maximum Tolerated Dose (MTD)

    One dose level below the dose level determined as DLT will be MTD.

    Measured: Day1 to day 38 (DLT observation period)

Secondary outcomes (12)

  1. Adverse events and Serious Adverse Events

    To asess the safety of HS-10241 single agent the combined with apatinib in patients with advanced solid tumor.

    Measured: From the day of ICF (Informed Consent Form) until 30 days after the last dose

  2. The measurement of maximum plasma concentration (Cmax)

    Including HS-10241 single dose （D1）/multiple dose of HS-10241（D17） and multiple dose of Apatinib（D38）.

    Measured: Day 1 to day 38

  3. The measurement of the area under the plasma concentration-time versus time curve(AUC)

    Area Under Curve(AUC0-t) will be measured after single dose administration of HS-10241 at day 1.AUC0-t and AUC0-inf are measured after repeated once-daily dose administration of HS-10241 at day 14.AUC0-t and AUC0-inf are measured after repeat once-daily dose administration of apatinib at day 38.

    Measured: Day 1 to day 38

  4. The measurement of the area under the plasma concentration-time versus time curve(AUC)

    AUC(0-inf) will be measured after single dose administration of HS-10241 at day 1.AUC0-t and AUC0-inf are measured after repeated once-daily dose administration of HS-10241 at day 14.AUC0-t and AUC0-inf are measured after repeat once-daily dose administration of apatinib at day 38.

    Measured: Day 1 to day 38

  5. The measurement of time of maximum plasma concentration (Tmax)

    Including HS-10241 single dose （D1）/multiple dose of HS-10241（D17） and multiple dose of apatinib（D38）.

    Measured: Day 1 to day 38

  6. The measurement of elimination half life (T1/2)

    T1/2 is measured after single dose administration of HS-10241 at day 1. T1/2 is measured after repeat once-daily dose administration of HS-10241 at day 17.

    Measured: Day 1 to day 38

  7. The Measurement of mean retention time (MRT)

    MRT is measured after single dose administration of HS-10241 at day 1.

    Measured: Day 1 to day 38

  8. The measurement of apparent volume of distribution (Vd)

    Vd is measured after single dose administration of HS-10241 at day 1. Vd is measured after repeated once-daily dose administration of HS-10241 at day 17.

    Measured: Day 1 to day 38

  9. The measurement of clearance (Cl)

    Vd is measured after single dose administration of HS-10241 at day 1. Vd is measured after repeated once-daily dose administration of HS-10241 at day 17.

    Measured: Day 1 to day 38

  10. Duration of Response Rate

    Determined using RECIST v1.1 criteria

    Measured: Approximately 1 year

  11. Progression-Free Survival

    Determined using RECIST v1.1 criteria

    Measured: Approximately 1 year

  12. Objective Response Rate

    Determined using RECIST v1.1 criteria

    Measured: Approximately 1 year

Timeline

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

  1. First posted9 Aug 2017
  2. Study start8 Aug 2017
  3. Primary completionJul 2019 (estimated)
  4. Study completionDec 2019 (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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243643
Sponsor's protocol ID
HS-10241-I-101
Acronym
HS:Hansoh;
Status last verified
Jul 2017
First submitted
18 Jul 2017
Last updated
8 Sep 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10241 and Apatinib in people with Advanced Cancer, run by Jiangsu Hansoh 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 16 inclusion and 18 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 8 Sep 2017. 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?

Results are not available in the source record.

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

Contact Yi Li, Ph.D (021-68868570, liuy@shhrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Day1 to day 38 (DLT observation period)). 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 NCT03243643.

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 8 Sep 2017.

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