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A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Melanoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671513
Recruitment Status : Unknown
Verified January 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 2, 2016
Last Update Posted : April 12, 2016
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
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 melanoma patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.

Condition or disease Intervention/treatment Phase
Melanoma Drug: SHR6390 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Tolerability and Pharmacokinetics Phase 1 Study of SHR6390 in Advanced Melanoma Patients
Study Start Date : January 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: SHR6390
Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen.
Drug: SHR6390
SHR6390 either 50mg,75mg,100mg,125mg,150mg,175mg given orally, QD




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 3 weeks ]
    The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the first 3 week of the first cycle of multiple dosing.


Secondary Outcome Measures :
  1. Evaluation of pharmacokinetic parameter of SHR6390: Cmax [ Time Frame: 6 weeks ]
  2. Evaluation of pharmacokinetic parameter of SHR6390: Tmax [ Time Frame: 6 weeks ]
  3. Evaluation of pharmacokinetic parameter of SHR6390: t1/2 [ Time Frame: 6 weeks ]
  4. Evaluation of pharmacokinetic parameter of SHR6390: AUC [ Time Frame: 6 weeks ]
  5. Number of patients experience adverse events [ Time Frame: 6 months ]
  6. objective response rate [ Time Frame: every 8 weeks, up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed melanoma
  • Unresectable stage III or IV melanoma patient
  • companion with cell cycle pathway abnormal (e.g CDK4 amplify and/or CCND1 amplify and/or CDKN2A loss)
  • 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 > 100g/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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671513


Contacts
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Contact: Jun Guo, M.D guoj307@126.com
Contact: Yi Liu, Ph.D liuy@shhrp.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Jun Guo, M.D       guoj307@126.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Beijing Cancer Hospital
Investigators
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Principal Investigator: Jun Guo, M.D Beijing Cancer hospital,Peking University
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02671513    
Other Study ID Numbers: SHR6390-I-102
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Melanoma
Cycline-Dependent Kinase
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas