Gastric CancerPhase 2NCT02596256
Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer (AHEAD-301)
A Phase 2 study testing Apatinib and Docetaxel in people with Gastric Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Feb 2019
- Phase
- Phase 2
- 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
- Age: more than 18 years old, male or female;
- Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥ 10mm on spiral computed tomography(CT) scan, satisfying the criteria in Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
- Failure of prior therapy (during or after treatment) in patients who have received at first line chemotherapy regimens(platinum - based regimens);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
- Major organ function has to meet the following criteria; (1) For results of blood routine test and biochemical tests:
- Hemoglobin (HB) ≥ 80g / L,
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- ANC ≥ 1.5 × 109 / L,
- PLT ≥ 90 × 109 / L,
- ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤5 × ULN,
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN),
- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN),
- Serum albumin ≥ 30g / L;
- An expected survival of ≥ 3 months;
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Who cannot join
- Confirmed that apatinib and/or its accessories allergy;
- Subjects with 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;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
- Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
- Associated with CNS (central nervous system) metastases;
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- Pregnant or lactating women;
- Pts with other malignant tumor within 5 years;
- With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- Participated in other clinical trials within 4 weeks;
- Pts received VEGFR inhibitor treatment(i.e. sorafenib, sunitinib);
- Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.
Read the detailed description
This trial investigated the safety and efficacy of apatinib plus docetaxel, as a treatment option for heavily pretreated patients with advanced gastric cancer.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called ATAN
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
DocetaxelDrug
Docetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Apatinib Mesylate Tablets (500 mg qd p.o.) and Docetaxel (60mg/m2 i.v. d1 q21d) Receives: Drug: Apatinib; Drug: Docetaxel |
| contrast group | Active comparator | Docetaxel (60mg/m2, i.v. d1 q21d) Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596256
- Sponsor's protocol ID
- AHEAD-301
- Status last verified
- Apr 2018
- First submitted
- 2 Nov 2015
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
- ClinicalTrials.gov ID
- NCT02596256
- Acronym / sponsor ID
- AHEAD-301
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 4 Nov 2015 (estimated)
- 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.
Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.
Detailed description
This trial investigated the safety and efficacy of apatinib plus docetaxel, as a treatment option for heavily pretreated patients with advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Drug: Apatinib, Drug: DocetaxelApatinib Mesylate Tablets (500 mg qd p.o.) and Docetaxel (60mg/m2 i.v. d1 q21d) |
| contrast group | Active comparator | Drug: DocetaxelDocetaxel (60mg/m2, i.v. d1 q21d) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: more than 18 years old, male or female;
- Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥ 10mm on spiral computed tomography(CT) scan, satisfying the criteria in Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
- Failure of prior therapy (during or after treatment) in patients who have received at first line chemotherapy regimens(platinum - based regimens);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
- Major organ function has to meet the following criteria; (1) For results of blood routine test and biochemical tests:
Key exclusion criteria (13 listed)
- Confirmed that apatinib and/or its accessories allergy;
- Subjects with 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;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
- Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
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: ATANApatinib (500 mg qd p.o.) until disease progression or intolerable toxicity | Drug | control group |
| DocetaxelDocetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity | Drug | contrast group, control group |
Primary outcome
Progression free survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Docetaxel in people with Gastric Cancer, run by Chinese PLA General 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 15 inclusion and 13 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 17 Apr 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Progression free survival (time frame: 6 months). 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 17 Apr 2018.