A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment

NCT02711969 | Completed Phase 1

• 1 other identifier: BK-AM-GC102
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in patients with unresectable locally advanced or metastatic Gastric cancer failed to standard therapy.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer

  Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03

  First 28 days of dosing

Secondary Outcomes (2)

• Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities

  From date of registration to time of first progressive disease(PD) or death, an average of 1 year

• Duration of Response(Stable disease, partial response or Complete response)

  From date of registration to time of first progressive disease(PD) or death, an average of 1 year

Study Arms (1)

Apatinib mesylate

EXPERIMENTAL

Drug: Apatinib mesylate

Interventions

Apatinib mesylate DRUG

1,000mg Apatinib mesylate p.o. qd

Apatinib mesylate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
• Failure or noncompliance of existing standard treatment without alternative treatment
• Measurable disease measured by proper image examination defined by RECIST 1.1
• Life expectancy ≥ 3 months
• Subject must be suitable for oral administration of study medication
• Subject who can submit a written consent form before participating in the test
• Adequate bone marrow, renal, and liver function
• Electrocorticography(ECOG) performance status ≤ 2
• Ability and willingness to comply with the study protocol for the duration of the study

You may not qualify if:

• Pregnant or lactating women
• Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of YN968D1
• Hemoptysis within 3 months prior to first scheduled dose of YN968D1
• Cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
• Surgery or biopsy within 28 days prior to first scheduled dose of YN968D1
• Minor surgery within 7 days prior to first scheduled dose of YN968D1
• Patients who have experience using YN968D1 before
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
• Known history of human immunodeficiency virus infection (HIV)
• Medical history of other cancers (including blood cancer) in the 5 years
• Radiology therapy to target lesion within 28 days, or diagnosis of other cancer within 14 days prior to first scheduled dose of YN968D1
• History of bleeding diathesis or bleeding within 14 days prior to enrollment
• Medical history of clinically significant thrombosis (bleeding or clotting disorder) within the past 3-months
• History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months
• History of idiopathic or hereditary angioedema, sickle cell or any hemolytic anemia

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Asan medical center

Seoul, Songpa-gu, South Korea

Location

Related Publications (1)

• Kang YK, Ryu MH, Hong YS, Choi CM, Kim TW, Ryoo BY, Kim JE, Weis JR, Kingsford R, Park CH, Jang S, McGinn A, Werner TL, Sharma S. Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in Patients with Advanced Solid Tumors. Cancer Res Treat. 2024 Jul;56(3):743-750. doi: 10.4143/crt.2023.980. Epub 2024 Jan 18.

  PMID: 38271925 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 Officials

• Yoon-Koo Kang, PhD

  Seoul Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 17, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2019
• Last Updated: July 22, 2022

Record last verified: 2018-07

Locations

KR (1)