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HER2 Positive Gastric CancerPhase 1NCT02378389

Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer

A Phase 1 study testing Pyrotinib/Pyrotinib with Docetaxel in people with HER2 Positive Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 4 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HER2 Positive Gastric Cancer
What is being tested?
Pyrotinib/Pyrotinib with Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesChina
Study dates
Sep 2014to Aug 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • At least one measurable lesion exists.(RECIST 1.1).
  • Histologically or cytologic confirmed HER2 positive advanced gastric cancer (including adenocarcinoma of esophageal-gastric junction), with clinical phase III/IV.
  • No severe impairment of liver and kidney function, required laboratory values including following parameters:ANC:≥1.5x109/L, Platelet count:≥90x109/L, Hemoglobin:≥9.0 g/dL, Total bilirubin:≤1xULN, ALT and AST: ≤1.5xULN (for patients with liver metastases,ALT and AST:≤5xULN), ALP:≤2.5xULN, BUN and creatine:≤1xULN, creatine clearance rate:≥50 mL/min, LVEF:≥50%, QTcF:<450 ms (male), <470 ms (female),INR:≤1.5xULN, APTT:≤1.5xULN.
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  • Signed informed consent.
  • For subjects treated by Pyrotinib only:
  • Failed or intolerable of prior therapies.
  • For subjects treated by Pyrotinib with Docetaxel:
  • Failed or intolerable of prior therapies, no previous treatment of taxane, no previous treatment of HER2 targeted inhibitors.

Who cannot join

  • Subjects with third space fluid that can not be controled by drainage or other methods.
  • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  • Steroid treatment for more than 50 days, or in need of long-term use of steroids.
  • Less than 4 weeks from the last radiotherapy,chemotherapy，surgery，hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
  • Less than 4 weeks from the last clinical trial or adverse events of previous trials (not including alopecia or asthenia).
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
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  • Subjects who can not interrupt using of the drugs causing QT prolongation during study.
  • Subjects with intracranial lesions (by MRI or CT).
  • Subjects suffered from other malignancies during last 5 years, not including cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma.
  • Subjects with bone or skin as the only target lesion.
  • Receiving any other antitumor therapy.
  • Known history of hypersensitivity to any of the components or metabolites of the investigational drugs or to Tween-80.
  • Subjects with clear tendency of gastointestinal bleeding. Including the following: subjects with local active ulcer lesions and fecal occult blood (++) are excluded; subjects with less than 2 months from the last history of black stools or haematemesis are excluded; for subjects with fecal occult blood (+) and primary lesion not resected, endoscopy is required,if gastric ulcer is found and the principal investigator of the site consider possible occurence of gastointestinal bleeding, the subject should be excluded.
  • Ongoing infection or peripheral neuropathy (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test or reluctant to take effective contraceptive measures throughout the trial period.
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
  • Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
  • Known history of neurological or psychiatric disease, including epilepsy or dementia.

Trial locations and contacts

4 sites in 1 country.

Qing Yang, MD contact

157 0515 5017

yangqing@hrs.com.cn

China4 sites, 4 recruiting

  • Beijing Cancer Hospital, Peking University

    Beijing, Beijing Municipality, 100037

    Lin Shen, M.D, 010-88196391

    Lin Shen, M.D

    Recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jing Huang

    Not yet recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Guanghai Dai

    Not yet recruiting

  • Cancer center, Sun Yet-sen University

    Guangzhou, Guangdong

    Ruihua Xu, 020-87343135

    Ruihua Xu, M.D

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study of Pyrotinib In Combination With Docetaxel In Patients With HER2 Positive Advanced Gastric Cancer

Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer.

Being tested
Pyrotinib/Pyrotinib with Docetaxel

What participants receive

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

  • Pyrotinib/Pyrotinib with DocetaxelDrug

    Pyrotinib oral daily, 240 mg, 320 mg, 400 mg.... Docetaxel i.v. once every 21 days.

Study groups in NCT02378389
Study groupRoleWhat they receive
Pyrotinib/Pyrotinib with DocetaxelExperimentalSubjects would be treated with Pyrotinib (Part 1) or Pyrotinib with Docetaxel (Part 2). A subject is only allowed to participant in one part of this trial.
Receives: Drug: Pyrotinib/Pyrotinib with Docetaxel

What is being measured

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

  1. The maximum-tolerated dose (MTD) of Pyrotinib and that of Pyrotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    MTD will be defined as the maximum dose level at which no more than one subject out of three experience has a dose-limiting toxicity (DLT) upon completing one treatment cycle. DLT was defined as the certain AEs which were observed during the first cycle (D1-D21) of treatment

    Measured: 21 days

Secondary outcomes (7)

  1. Cmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    Measured: 12 months

  2. Tmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    Measured: 12 months

  3. T1/2 of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    Measured: 12 months

  4. AUCss of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    Measured: 12 months

  5. R of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer

    Measured: 12 months

  6. the number of participants with adverse event

    Measured: 12 months

  7. preliminary antitumor activity for the regimen

    Measured: 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 posted4 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2017 (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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02378389
Sponsor's protocol ID
BLTN-Id
Status last verified
Feb 2015
First submitted
11 Feb 2015
Last updated
4 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Liu D, Kou F, Gong J, Wang Z, Zhang X, Li J, Li Y, Li J, Zhou J, Lu M, Wang X, Lu Z, Cao Y, Zou J, Zhu X, Xu R, Shen L. Pyrotinib alone or in combination with docetaxel in refractory HER2-positive gastric cancer: A dose-escalation phase I study. Cancer Med. 2023 May;12(9):10704-10714. doi: 10.1002/cam4.5830. Epub 2023 Apr 20.

    PubMed 37081722

  • 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 Pyrotinib/Pyrotinib with Docetaxel in people with HER2 Positive Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 4 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 11 inclusion and 20 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Qing Yang, MD (157 0515 5017, yangqing@hrs.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum-tolerated dose (MTD) of Pyrotinib and that of Pyrotinib with Docetaxel in patients with HER2 positive advanced gastric cancer (time frame: 21 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 NCT02378389, which also lists 2 linked publications.

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 4 Mar 2015.

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