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CarcinomaPhase 1NCT02977364

A Trial of C-met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumours

A Phase 1 study testing HS-10241 in people with Carcinoma and Solid Tumor, Adult, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241 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 65 years
Conditions the study is for
Carcinoma, Solid Tumor, Adult
What is being tested?
HS-10241
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Nov 2016to Nov 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
  • c-MET positive patients preferred in dose escalation phase; c-MET of patients must fulfill ICH++~+++ or FISH≥4 times in dose expansion phase.
  • Confirmed that there are at least 1 can be measured in accordance with the standard RECIST1.1 by CT or MRI.
  • 18 ~65 years of age.
  • ECOG performance status of 0~1.
  • Life expectancy of at least 3 months.
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  • Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia).
  • Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
  • Absolute neutrophil count (ANC) ≥ 1500/μL
  • Platelet count ≥ 100000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Acceptable liver function defined below:
  • Total bilirubin ≤ 2 times upper limit of normal range (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 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 coagulation status defined below:
  • Prothrombin time < 1.5 times ULN
  • Partial thrombin time < 1.5 times UL
  • HIV Ag/Ab(-).
  • HCV Ab(-);or HCV Ab(+) but HCV RNA(-).
  • HBsAg（-）and HBcAb（-）in dose escalation phase；HBV DNA<1×103copies/ml if HBsAg（+）or HBcAb（+）in dose expansion phase.
  • Ability to understand the purposes and risks of the trial and his/her informed consent using the human research ethics committee (HREC) approved informed consent form was obtained before the entering the trial.

Who cannot join

  • Treatment with other c-MET TKI( specific target or multi-target)；
  • Anti-cancer treatment with radiation therapy（not including non target lesions receiving palliative radiotherapy）, chemotherapy,hormonotherapy or surgery（small surgery, including the implantation of external equipment or fine needle aspiration, at least 7 days; diagnostic or palliative surgery, at least 14 days） within 4 weeks (6 weeks for nitrosoureas or Mitomycin C)prior to trial entry.
  • Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
  • Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
  • Symptomatic brain metastases or unstable brain metastases (notes: Patients with asymptomatic brain metastases previously treated for the study, but must be kept stable for at least 4 weeks and receive a stable dose of the drug)
  • Obvious neurological and mental disorder.
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  • Other previous or concomitant tumors (except for the effective treatment of melanoma, cervical carcinoma in situ, ductal carcinoma in situ or malignant tumor after effective treatment, remission 3 years and considered to have been cured).
  • Active, uncontrolled bacterial, fungal infections, requiring systemic therapy.
  • Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 0.5 year of trial entry)
  • History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
  • Participation in an investigational drug or device trial within 4 weeks prior to the trial entry.
  • Anti-cancer treatment with radiation therapy, chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
  • Taking a medication that is a moderate or strong inhibitor or inducer of CYP2C9; taking a medication that prolongs QT interval and has a risk of Torsades de Pointes .
  • Pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment.
  • Known drug abuse or alcohol abuse.
  • Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.

Trial locations and contacts

1 site in 1 country.

Yuankai Shi, MD contact

86(10)87788293

syuankaipumc@126.com

China1 site, 1 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, MD, 86(10)87788293, syuankaipumc@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Trial to Investigate Safety and Tolerability Profile and Pharmacokinetics of C-met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumours

To investigate safety, tolerability and pharmacokinetics of C-met Kinase Inhibitor HS-10241 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 in advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of HS-10241 will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.

Being tested
HS-10241
Medical subject headings
Carcinoma

What participants receive

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

  • HS-10241Drug

Study groups in NCT02977364
Study groupRoleWhat they receive
HS-10241 100mgExperimentalHS-10241 100mg daily
Receives: Drug: HS-10241
HS-10241 200mgExperimentalHS-10241 200mg daily
Receives: Drug: HS-10241
HS-10241 400mgExperimentalHS-10241 400mg daily
Receives: Drug: HS-10241
HS-10241 600mgExperimentalHS-10241 600mg daily
Receives: Drug: HS-10241
HS-10241 800mgExperimentalHS-10241 800mg daily
Receives: Drug: HS-10241
HS-10241 1000mgExperimentalHS-10241 1000mg daily
Receives: Drug: HS-10241

What is being measured

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

  1. MTD of HS-10241 based on the incidence of dose limiting toxicities

    Measured: 4 weeks

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    Measured: 12 months

  2. Max concentration (Cmax) of HS-10241

    Measured: 4 weeks

  3. Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

    Measured: 8 weeks

  4. Incidence and intensity of Adverse Events according to Common Toxicity Criteria for AEs (CTCAE version 4.0)

    Measured: 8 weeks

  5. Area under the plasma concentration versus time curve (AUC) of HS-10241

    Measured: 4 weeks

  6. Elimination half-life(T1/2) of HS-10241

    Measured: 4 weeks

Timeline

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

  1. First posted30 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2021 (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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02977364
Sponsor's protocol ID
HS-10241-101
Status last verified
Nov 2016
First submitted
11 Nov 2016
Last updated
30 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10241 in people with Carcinoma and Solid Tumor, Adult, 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 23 inclusion and 17 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 30 Nov 2016. 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 Yuankai Shi, MD (86(10)87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of HS-10241 based on the incidence of dose limiting toxicities (time frame: 4 weeks). 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 NCT02977364.

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 30 Nov 2016.

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