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NeoplasmPhase 1NCT02684266

A Study of SHR6390 in Advanced Solid Tumor Patients

A Phase 1 study testing SHR6390 in people with Neoplasm, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 solid tumor 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
Neoplasm
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
40 participants
Where
1 siteChina
Study dates
3 Mar 2016to 28 Jun 2019
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 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
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  • 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(except grade 2 alopecia)
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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.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

Other trials in China

About this study

Official title: A Tolerability and Pharmacokinetics Study of SHR6390 in Advanced Solid Tumor 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 solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.

Conditions
Neoplasm
Being tested
SHR6390
Keywords
neoplasm, Cycline-Dependent Kinase
Medical subject headings
Neoplasms

What participants receive

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

  • SHR6390Drug

    SHR6390 either 25, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg given orally, QD

Study groups in NCT02684266
Study groupRoleWhat they receive
SHR6390ExperimentalEach 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.

  1. 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: 5 weeks

Secondary outcomes (6)

  1. Number of patients experience adverse events

    Measured: up to 12 months

  2. Evaluation of pharmacokinetic parameter of SHR6390: Cmax

    Measured: 6 weeks

  3. Evaluation of pharmacokinetic parameter of SHR6390: Tmax

    Measured: 6 weeks

  4. Evaluation of pharmacokinetic parameter of SHR6390: t1/2

    Measured: 6 weeks

  5. Evaluation of pharmacokinetic parameter of SHR6390: AUC

    Measured: 6 weeks

  6. 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.

  1. First posted17 Feb 2016 (estimated)
  2. Study start3 Mar 2016
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684266
Sponsor's protocol ID
SHR6390-I-101
Status last verified
Jul 2022
First submitted
12 Feb 2016
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Zhang P, Xu B, Gui L, Wang W, Xiu M, Zhang X, Sun G, Zhu X, Zou J. A phase 1 study of dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor in Chinese patients with advanced breast cancer. Biomark Res. 2021 Apr 12;9(1):24. doi: 10.1186/s40364-021-00271-2.

    PubMed 33845905

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR6390 in people with Neoplasm, 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 14 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: finished, as of the sponsor's last update on 11 Jul 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: 5 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 NCT02684266, which also lists 1 linked publication.

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 11 Jul 2022.

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