NCT02977364

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 11, 2016

Last Update Submit

November 27, 2016

Conditions

CarcinomaSolid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (6)

  • Progression-free survival (PFS)

    12 months

  • Max concentration (Cmax) of HS-10241

    4 weeks

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

    8 weeks

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

    8 weeks

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

    4 weeks

  • +1 more secondary outcomes

Study Arms (6)

HS-10241 100mg

EXPERIMENTAL

HS-10241 100mg daily

Drug: HS-10241

HS-10241 200mg

EXPERIMENTAL

HS-10241 200mg daily

Drug: HS-10241

HS-10241 400mg

EXPERIMENTAL

HS-10241 400mg daily

Drug: HS-10241

HS-10241 600mg

EXPERIMENTAL

HS-10241 600mg daily

Drug: HS-10241

HS-10241 800mg

EXPERIMENTAL

HS-10241 800mg daily

Drug: HS-10241

HS-10241 1000mg

EXPERIMENTAL

HS-10241 1000mg daily

Drug: HS-10241

Interventions

HS-10241DRUG
HS-10241 1000mgHS-10241 100mgHS-10241 200mgHS-10241 400mgHS-10241 600mgHS-10241 800mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \~65 years of age.
  • ECOG performance status of 0\~1.
  • Life expectancy of at least 3 months.
  • 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:
  • +8 more criteria

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Yuankai Shi, MD

CONTACT

86(10)87788293syuankaipumc@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2021

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)