A Study of SHR6390 in Advanced Solid Tumor Patients

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Hengrui Medicine

Status and phase

Completed
Phase 1

Conditions

Neoplasm

Treatments

Drug: SHR6390

Study type

Interventional

Funder types

Industry

Identifiers

NCT02684266
SHR6390-I-101

Details and patient eligibility

About

SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pathologically confirmed solid tumor and failed from all standard treatment

  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1

  • Life expectancy ≥ 3 months

  • Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:

    • Hemoglobin > 110g/L
    • Neutrophils > 2.0×10^9/L
    • Platelets > 100×10^9/L
    • Total bilirubin < 1.5×the upper limit of normal (ULN)
    • ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases)
    • Creatinine ≤ 1 ULN
    • Left ventricular ejection fraction (LVEF) ≥ 50%
    • QTcF(Fridericia correction) male≤450 ms, female≤470 ms
  • Good compliance of patient by physician's judgement

  • Signed and dated informed consent

Exclusion criteria

  • Previously received therapy of anti-tumor agent targeting at CDK4/6
  • Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
  • Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
  • Having joined in other clinical trials within 4 weeks
  • Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)
  • existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia)
  • uncontrollable symptomatic pleural effusion or ascites or require clinical intervention
  • require continous treatment by steroids
  • Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
  • existing uncontrollable hypokalemia or hypomagnesemia
  • history of serious allergy events or known being allergy constitution
  • active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)
  • History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
  • history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test childbearing female who refuse to accept any contraception practice
  • determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)
  • history of neuropathy or dysphrenia, including epilepsy and dementia

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

SHR6390
Experimental group
Description:
Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen
Treatment:
Drug: SHR6390

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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