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Gastric CancerPhase 1NCT03480256

Study to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Gastric Cancer

A Phase 1 study testing SHR6390 in people with Gastric Cancer, run by Peking University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to assess the safety and tolerability of SHR6390 combined with pyrotinib in the patients with Her-2 positive advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
SHR6390
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
27 Jul 2018to Aug 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients definitely diagnosed by pathology as Her2 positive stage III/IV gastric cancer
  • 18-75 years old, ECOG PS:0-1,Life expectancy of more than12 weeks;
  • Patients treated with systematic treatment to metastatic disease then experienced progressive disease
  • Patients with at least one evaluable or measurable disease per RECIST v1.1
  • Main organs function is normal;
  • Patients should be voluntary and sign the informed consent before taking part in the study;

Who cannot join

  • • Patients who have uncontrollable effusion with clinical symptoms such as severe pleural effusion and peritoneal effusion;
  • A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
  • Patients who have steroid treatment for more than 30 days or need long-term steroid treatment;
  • Patients who had previously received chemotherapy，radiotherapy, hormonotherapy,surgery,targeted therapy(including Trastuzumab) within 2 weeks ;patients who had previously received nitrosourea or Mitomycin with 6 weeks;
  • Previous treatment-related adverse events did not recover to less than 2 levels except hair loss or other conditions that did not affect the enrollment according to investigators;
  • Patients who have participated in other anticancer drug clinical trials within 4 weeks except that trial is observational or at follow up stage;
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  • Patients who have uncontrollable hypomagnesemia or hypokalemia;
  • Patients with untreated or symptomatic brain metastasis;
  • Patients with malignant tumors within 5 years, except for basal cell carcinoma,squamous skin cancer and cervical carcinoma in situ;
  • Patients who are being treated with any other anticancer strategies;
  • Patients with allergic constitution or being allergic to any element in the study drugs;
  • Patients with definite gastrointestinal bleeding tendency, including: active ulcer lesions with OB(++);melena or haematemesis history within 2 months; patients with OB(+) but without tumor resection need gastroscopy. If there is active bleeding, it's not suitable for this trial;
  • Patients with active infection, including tuberculosis;
  • Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
  • Patients who have had severe cardiac disease within six months, including acute coronary syndrome, arrhythmias that require medication or with clinical significance, or need continuous medication that may cause QT extension, acute myocardial infarction,heart failure,and any other condition that is not suitable for this experiment according to the investigators;
  • Patients who are pregnant or breast feeding;
  • Patients who don't agree on contraception; Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators such as hypertension, severe diabetes and thyroid diseases;
  • Patients with bad addiction such as excessive drinking or smoking;
  • Patients with definite mental disorder, including epilepsy and dementia.

Trial locations and contacts

2 sites in 1 country.

Jifang Gong contact

13683208528

goodjf@163.com

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Shen Lin, Professor, 010-88196561, Linshenpku@163.com

    Shen Lin, professor

    Recruiting

  • Department of GI Oncology, Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jifang Gong, MD, 861088196561, gongjifang@gmail.com

    Lin Shen, MD

    Not yet recruiting

Other trials in China

About this study

Official title: Phase Id Trial to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Advanced Stage Gastric Carcinoma

The aim of the study is to assess the safety and tolerability of SHR6390 combined with pyrotinib in the patients with Her-2 positive advanced gastric cancer.

Conditions
Gastric Cancer
Being tested
SHR6390
Keywords
SHR6390, Pyrotinib, gastric cancer, Her-2 positive
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • SHR6390Drug

    SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic gastric cancer

Study groups in NCT03480256
Study groupRoleWhat they receive
SHR6390 combined with pyrotinibExperimentalGroup A:pyrotinib 400mg qd combined with SHR 6390 100mg qd Group B: pyrotinib 400mg qd combined with SHR 6390 125mg qd Group C: pyrotinib 400mg qd combined with SHR 6390 150mg qd Group D: pyrotinib 400mg qd combined with SHR 6390 175mg qd Group E: pyrotinib 320mg qd combined with SHR 6390 100mg qd
Receives: Drug: SHR6390

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Measured: 42 days

Secondary outcomes (2)

  1. Maximum Plasma Concentration

    Measured: 42 days

  2. Area Under the Curve

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start27 Jul 2018
  3. Primary completionNov 2019 (estimated)
  4. Study completionAug 2020 (estimated)

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
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480256
Sponsor's protocol ID
SHR6390-Id
Status last verified
Mar 2019
First submitted
8 Mar 2018
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Z, Xu Y, Gong J, Kou F, Zhang M, Tian T, Zhang X, Zhang C, Li J, Li Z, Lai Y, Zou J, Zhu X, Gao J, Shen L. Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients. Clin Transl Med. 2020 Aug;10(4):e148. doi: 10.1002/ctm2.148.

    PubMed 32898333

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR6390 in people with Gastric Cancer, run by Peking University at 2 sites 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 6 inclusion and 19 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 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Jifang Gong (13683208528, goodjf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 42 days). 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 NCT03480256, 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 14 Mar 2019.

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