Apatinib Plus Docetaxel Versus Docetaxel as Second-line Treatment in Advanced Gastric Cancer (AHEAD-301)

NCT02596256 | Unknown Phase 2

• 1 other identifier: AHEAD-301
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Apatinib plus docetaxel versus docetaxel as second-line treatment in advanced gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  6 months

Study Arms (2)

control group

EXPERIMENTAL

Apatinib Mesylate Tablets (500 mg qd p.o.) and Docetaxel (60mg/m2 i.v. d1 q21d)

Drug: Apatinib; Drug: Docetaxel

contrast group

ACTIVE COMPARATOR

Docetaxel (60mg/m2, i.v. d1 q21d)

Drug: Docetaxel

Interventions

Apatinib DRUG

Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity

Also known as: ATAN

control group

Docetaxel DRUG

Docetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity

contrast group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: April 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CN (1)