A Clinical Trial of Apatinib Plus Docetaxel in Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma

February 28, 2017 updated by: Hongming Pan, MD, Sir Run Run Shaw Hospital

A Phase I Dose Escalation Clinical Trial of Apatinib Tablets Plus Docetaxel as Second-line Treatment in Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

This study evaluated the tolerance, safety and efficacy of Apatinib plus Docetaxel as the second-line treatment in locally advanced or metastatic gastric cancer (including Gastroesophageal junction (GEJ) Adenocarcinoma).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hongming Pan, MD
  • Phone Number: +86-13605716662

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Pan Hongming, MD
          • Phone Number: +86-13605716662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
  2. Age: ≥18 years old;

  3. Locally advanced or metastatic gastric cancer (including Gastroesophageal junction (GEJ) Adenocarcinoma ) patients confirmed by radiologic imaging or endoscopy tests, who had failed in first-line treatments;

    • First-line treatment should be 5-Fu combined with platinum based regimen;
    • Adjuvant/neoadjuvant chemotherapy should be defined as the first-line treatment, if recurrence happened within 6 months after completion of 5-Fu and platinum based adjuvant/ neoadjuvant chemotherapy;
  4. Adjuvant/neoadjuvant chemotherapy history is allowed, if first-line treatment is applied more than 6 months later than prior treatments;
  5. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
  6. ECOG Performance Status ≤1;
  7. Life expectancy shouldn't less than 16 weeks, since the first medicine application time;

  8. Major organ function has to meet the following criteria (within 28 days before treatment):

    • HB ≥9.0 g/dL
    • ANC ≥1.5X109/L
    • PLT ≥100x109/L
    • Bilirubin ≤1.5 times the upper limit of normal (ULN)
    • ALT (SGOT) and AST (SGPT) ≤2.5 × ULN, unless liver metastases; if any, the ALT and AST≤5 × ULN
    • Serum Cr ≤ 1.5 x ULN
  9. Patients must have at least one assessable lesion (including measurable and/or immeasurable) by radiological imagine (CT/MRI);

  10. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 28 days before enrollment and the test result must be negative. Or menopause women, defined as follow:

    • ≥1 year no menstruation, after abort exogenous hormone treatment
    • Serum LH and FSH meet menopause criteria
    • More than 1 year no menstruation for ovarian function failure induced by radiation therapy.
    • More than 1 year no menstruation for menopause induced by chemotherapy
    • Surgical sterilization accepted (hysterectomy or ovariectomy)

Exclusion Criteria:

  1. Involved in another on-going clinical trials;
  2. Accept more than one chemotherapy previously in advanced gastric cancer (except more than 6 months from adjuvant/neoadjuvant treatment);
  3. Prior taxane treatment (including Paclitaxel and Docetaxel);
  4. Prior VEGFR inhibitor treatment (including Sorafenib and Sunitinib);
  5. History of another malignancy within the last five years except cured nonmelanoma Skin cancer and carcinoma in situ of uterine cervix;
  6. Any factors that influence the usage of oral administration;
  7. History of the investigational agent treatment in 14 day prior to enroll in study (longer time period may be required which depends on drug characteristic);
  8. Accept any chemotherapy and radiotherapy (excluding Palliative radiotherapy) in 3 weeks prior to study (longer time period may be required which depends on drug characteristic);
  9. Poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction; Patients with positive urinary protein;
  10. Poor-controlled adverse events (excluding Alopecia) induced by tumor therapy (>class 1 CTCAE);
  11. History of intestinal obstruction or more than class 3 or 4 (CTCAE) gastrointestinal bleeding in 4 weeks prior to enroll in study;
  12. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
  13. Clinical evidence in central nervous system (CNS) and poor-controlled CNS metastasis (No necessary to confirm negative CNS metastasis by CT/MRI);
  14. Surgery within 2 weeks prior to enroll in study;
  15. History of significant and poor-controlled diseases or infection, in the opinion of investigators, may impact the safety of the patients of the study;
  16. Known history of human immunodeficiency, e.g. HIV positive;
  17. Known or suspected allergy to the investigational agent or any agent given in association with this trial;
  18. Pregnant or lactating patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apatinib plus Docetaxel
Each subject will receive one dose of Apatinib in the whole cycle (21 days), during which single dose induced DLT and safety monitoring will be performed. If the initial dose is well tolerated, next cycle the subject will receive more Apatinib as respectively. This study will enroll in 4 cohorts of Apatinib; cohort 1 at the dose of 425mg Apatinib, which followed by cohort 2(500mg), cohort 3(675mg) and cohort 4(750mg).
Drug: Apatinib
Apatinib Mesylate Tablets 425mg (500mg，675mg or 750mg) po. qd continuous;
Other Names:
  • YN968D1,(AiTan®)
Drug: Docetaxel
Docetaxel 60mg/m2 ivgtt day 1, q21d Combined use of Docetaxel and Apatinib
Other Names:
  • Aisu®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Tolerance profile of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: At least 4 weeks
At least 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu HengRui Medicine Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hongming Pan, MD, The Affiliated Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ahead-G306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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