A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

NCT02426034 | Completed Phase 4

• 1 other identifier: Ahead-G201
• Study Type: interventional
• Target: 2,004
• Locations: 1 country
• Sites: 2

Brief Summary

The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.

Conditions

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

Advanced; Metastatic

Outcome Measures

Primary Outcomes (1)

• Safety, which was assessed by recording the incidence and severity of adverse events

  between first dose of apatinib and up to 30 days after the last dose of apatinib

Secondary Outcomes (5)

• Overall Survival

  Event driven, an expected average of 34 weeks

• Progression Free Survival

  An expected average of 12 weeks

• Objective Response Rate

  An expected average of 12 weeks

• Disease Control Rate

  An expected average of 12 weeks

• Quality of life, measured by the questionnaire of EORTC QLQ-C30

  Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Apatinib Tablets

Drug: ApatinibTablets

Interventions

ApatinibTablets DRUG

Apatinib Tablets, recommended dose of 850mg

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to75 years old;
• Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
• Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
• ECOG PS of 0-2;
• Major organ function has to meet the following criteria:
• For results of blood routine test (without blood transfusion within 14 days):
• HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L
• Biochemical tests results:
• Bilirubin \<1.25 times the upper limit of normal (ULN) ALT and AST \<2.5 × ULN; liver metastases, if any, the ALT and AST\<5 × ULN Serum Cr ≤ 1 × ULN endogenous creatinine clearance\>50ml/min (Cockcroft-Gault formula)
• An expected survival of ≥ 3 months;
• Patient received apatinib treatment regimen at investigators' discretion;
• Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
• 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.

You may not qualify if:

• Subjects with uncontrolled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man \> 450 ms, for woman \> 470 ms), as well as Grade ≥ 2 cardiac dysfunction;
• 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: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; 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 finding;
• Abnormal coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleeding;
• Presence of central nervous system metastases;
• Pregnant or lactating women;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Nanjin Military 81 Hosiptal

Nanjing, Jiangsu, China

Location

Fudan University cancer hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Li J, Qin S, Wen L, Wang J, Deng W, Guo W, Jia T, Jiang D, Zhang G, He Y, Ba Y, Zhong H, Wang L, Lin X, Yang J, Zhao J, Bai Y, Wu X, Gao F, Sun G, Wu Y, Ye F, Wang Q, Xie Z, Yi T, Huang Y, Yu G, Lu L, Yuan Y, Li W, Liu L, Sun Y, Sun Y, Yin L, Hou Z. Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study. BMC Med. 2023 May 5;21(1):173. doi: 10.1186/s12916-023-02841-7.

  PMID: 37147645 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A large-scale single-arm phase IV study

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 24, 2015
• Study Start: May 15, 2015
• Primary Completion: May 29, 2020
• Study Completion: September 3, 2020
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (2)