Metastatic Gastric AdenocarcinomaPhase 1NCT03071042
A Clinical Trial of Apatinib Plus Docetaxel in Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma
A Phase 1 study testing Apatinib and Docetaxel in people with Metastatic Gastric Adenocarcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Adenocarcinoma
- What is being tested?
- Apatinib and Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
- Age: ≥18 years old;
- 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;
- Adjuvant/neoadjuvant chemotherapy history is allowed, if first-line treatment is applied more than 6 months later than prior treatments;
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- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- ECOG Performance Status ≤1;
- Life expectancy shouldn't less than 16 weeks, since the first medicine application time;
- 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
- Patients must have at least one assessable lesion (including measurable and/or immeasurable) by radiological imagine (CT/MRI);
- 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)
Who cannot join
- Involved in another on-going clinical trials;
- Accept more than one chemotherapy previously in advanced gastric cancer (except more than 6 months from adjuvant/neoadjuvant treatment);
- Prior taxane treatment (including Paclitaxel and Docetaxel);
- Prior VEGFR inhibitor treatment (including Sorafenib and Sunitinib);
- History of another malignancy within the last five years except cured nonmelanoma Skin cancer and carcinoma in situ of uterine cervix;
- Any factors that influence the usage of oral administration;
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- 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);
- 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);
- 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;
- Poor-controlled adverse events (excluding Alopecia) induced by tumor therapy (>class 1 CTCAE);
- History of intestinal obstruction or more than class 3 or 4 (CTCAE) gastrointestinal bleeding in 4 weeks prior to enroll in study;
- Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
- Clinical evidence in central nervous system (CNS) and poor-controlled CNS metastasis (No necessary to confirm negative CNS metastasis by CT/MRI);
- Surgery within 2 weeks prior to enroll in study;
- History of significant and poor-controlled diseases or infection, in the opinion of investigators, may impact the safety of the patients of the study;
- Known history of human immunodeficiency, e.g. HIV positive;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
Hongming Pan, MD contact
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Pan Hongming, MD, +86-13605716662
About this study
Official title: 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).
- Conditions
- Metastatic Gastric Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1,(AiTan®)
Apatinib Mesylate Tablets 425mg (500mg，675mg or 750mg) po. qd continuous;
DocetaxelDrug
Also called Aisu®
Docetaxel 60mg/m2 ivgtt day 1, q21d Combined use of Docetaxel and Apatinib
| Study group | Role | What they receive |
|---|---|---|
| Apatinib plus Docetaxel | Experimental | 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). Receives: Drug: Apatinib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance profile of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: At least 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Hongming Pan, MD, Sir Run Run Shaw Hospital
- Investigators
- Hongming Pan, MD, Study chair, The Affiliated Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071042
- Sponsor's protocol ID
- Ahead-G306
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2016
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03071042
- Acronym / sponsor ID
- Ahead-G306
- Conditions
- Metastatic Gastric Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 6 Mar 2017 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib plus Docetaxel | Experimental | Drug: Apatinib, Drug: DocetaxelEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
- Age: ≥18 years old;
- 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;
- Adjuvant/neoadjuvant chemotherapy history is allowed, if first-line treatment is applied more than 6 months later than prior treatments;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
Key exclusion criteria (18 listed)
- Involved in another on-going clinical trials;
- Accept more than one chemotherapy previously in advanced gastric cancer (except more than 6 months from adjuvant/neoadjuvant treatment);
- Prior taxane treatment (including Paclitaxel and Docetaxel);
- Prior VEGFR inhibitor treatment (including Sorafenib and Sunitinib);
- History of another malignancy within the last five years except cured nonmelanoma Skin cancer and carcinoma in situ of uterine cervix;
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 |
|---|---|---|
| ApatinibAlso: YN968D1,(AiTan®)Apatinib Mesylate Tablets 425mg (500mg，675mg or 750mg) po. qd continuous; | Drug | Apatinib plus Docetaxel |
| DocetaxelAlso: Aisu®Docetaxel 60mg/m2 ivgtt day 1, q21d Combined use of Docetaxel and Apatinib | Drug | Apatinib plus Docetaxel |
Primary outcome
Tolerance profile of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: At least 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hongming Pan, MD contact
Hongming Pan, MD study chair
The Affiliated Sir Run Run Shaw Hospital
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 Apatinib and Docetaxel in people with Metastatic Gastric Adenocarcinoma, run by Sir Run Run Shaw Hospital 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 23 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 6 Mar 2017. 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 Hongming Pan, MD (+86-13605716662), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance profile of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: At least 4 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 6 Mar 2017.