MelanomaPhase 1NCT02671513
A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Melanoma Patients
A Phase 1 study testing SHR6390 in people with Melanoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melanoma
- What is being tested?
- SHR6390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Apr 2017
- 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
- 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:
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Jun Guo, M.D contact
Yi Liu, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Guo, M.D, guoj307@126.com
About this study
Official title: A Tolerability and Pharmacokinetics Phase 1 Study of SHR6390 in Advanced Melanoma Patients
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.
- Conditions
- Melanoma
- Being tested
- SHR6390
- Keywords
- Melanoma, Cycline-Dependent Kinase
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390Drug
SHR6390 either 50mg,75mg,100mg,125mg,150mg,175mg given orally, QD
| Study group | Role | What they receive |
|---|---|---|
| SHR6390 | Experimental | Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen. Receives: Drug: SHR6390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
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.
Measured: 3 weeks
Secondary outcomes (6)
Evaluation of pharmacokinetic parameter of SHR6390: Cmax
Measured: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: Tmax
Measured: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: t1/2
Measured: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: AUC
Measured: 6 weeks
Number of patients experience adverse events
Measured: 6 months
objective response rate
Measured: every 8 weeks, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Jun Guo, M.D, Principal investigator, Beijing Cancer hospital,Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671513
- Sponsor's protocol ID
- SHR6390-I-102
- Status last verified
- Jan 2016
- First submitted
- 24 Jan 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tolerability and Pharmacokinetics Phase 1 Study of SHR6390 in Advanced Melanoma Patients
- ClinicalTrials.gov ID
- NCT02671513
- Acronym / sponsor ID
- SHR6390-I-102
- Conditions
- Melanoma
- Keywords
- Melanoma, Cycline-Dependent Kinase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR6390 | Experimental | Drug: SHR6390Each subject will receive a single dose of SHR6390 and then repeat doses following a 3 week/1 week off regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR6390SHR6390 either 50mg,75mg,100mg,125mg,150mg,175mg given orally, QD | Drug | SHR6390 |
Primary outcome
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.
6 secondary outcomes
Evaluation of pharmacokinetic parameter of SHR6390: Cmax
Time frame: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: Tmax
Time frame: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: t1/2
Time frame: 6 weeks
Evaluation of pharmacokinetic parameter of SHR6390: AUC
Time frame: 6 weeks
Number of patients experience adverse events
Time frame: 6 months
objective response rate
Time frame: every 8 weeks, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo, M.D contact
Yi Liu, Ph.D contact
Jun Guo, M.D principal investigator
Beijing Cancer hospital,Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR6390 in people with Melanoma, run by Jiangsu HengRui Medicine 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 9 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 12 Apr 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 Jun Guo, M.D (guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2016.