Apatinib Dose Titration in Advanced or Metastatic Gastric Cancer

NCT02764268 | Completed

• 1 other identifier: HR-APTN-DT-AGC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Apatinib dose titration in Advanced or Metastatic Gastric Cancer

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Pharmacokinetics; Dose titration

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Interruptions

  15 months

Secondary Outcomes (3)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0

  15 months

• Objective Response Rate(ORR)

  15 months

• Disease Control Rate(DCR)

  15 months

Study Arms (1)

Apatinib

EXPERIMENTAL

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 70 years of age
• Histological confirmed advanced or metastatic adenocarcinoma of the stomach
• Have failed for at least 2 lines of chemotherapy
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
• More than 4 weeks for operation or radiotherapy or cytotoxic agents
• Adequate hepatic, renal, heart, and hematologic functions

You may not qualify if:

• Pregnant or lactating women
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
• Any factors that influence the usage of oral administration
• Evidence of central nerves system metastasis
• Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure
• proteinuria ≥ (+)
• International Normalized Ratio \> 1.5 and activated partial thromboplastin time \> 1.5 × Upper limit of normal（ULN）
• Certain possibility of gastric or intestine hemorrhage
• Less than 4 weeks from the last clinical trial
• Prior VEGFR inhibitor treatment
• Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (1)

• Wang Y, Wang C, Zhang Y, Hao J, Yang N, Wang J, Peng M, Liu T, Zhang G, Zhan X, Zeng S, Zhang Y, Gao Y, Yao Y. Multiple-dose up-titration study to evaluate the pharmacokinetics, safety and antitumor activity of apatinib in advanced gastric adenocarcinoma. Front Oncol. 2022 Oct 18;12:876899. doi: 10.3389/fonc.2022.876899. eCollection 2022.

  PMID: 36330490 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 6, 2016
• Study Start: November 2, 2016
• Primary Completion: December 10, 2018
• Study Completion: April 15, 2019
• Last Updated: March 11, 2022

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)