Gastric CancerPhase 1NCT02711969
A Study of Apatinib Mesylate (YN968D1) 1,000mg in Gastric Cancer Patient Failed to Standard Treatment
A Phase 1 study testing Apatinib mesylate in people with Gastric Cancer, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 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
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- 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
Who cannot join
- 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
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- 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
- History of uncontrolled hypertension that in the opinion of the investigator
- Complete Left bundle branch block (LBBB) or bifascicular (RBBB and left anterior or posterior hemi-block)
- Clinically significant S-T segment or T wave abnormality
- Abnormal atrial fibrillation
- History of ECOG or left ventricular ejection fraction (LVEF) abnormality during last 3 months in the opinion of the investigator
- Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication
- Congestive heart failure (New York Heart Association class III-IV)
- History of other significant cardiovascular disease or vascular disease within the last 6 months
- History of clinically significant glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
- Half-life of other investigator drug is not passed over fivefold or 30 days prior to clinical trial
- Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may affect compliance with scheduled visits
- Known hypersensitivity to YN968D1 or components of the formulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy
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
- Being tested
- Apatinib mesylate
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib mesylateDrug
1,000mg Apatinib mesylate p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| Apatinib mesylate | Experimental | Not described Receives: Drug: Apatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 28 days of dosing
Secondary outcomes (2)
Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities
Incidence and severity of treatment-related adverse events reported and their relationship to Apatinib mesylate will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3)
Measured: 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)
Tumor response and progression will be evaluated using RECIST v 1.1.
Measured: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon-Koo Kang, PhD, Principal investigator, Seoul Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711969
- Sponsor's protocol ID
- BK-AM-GC102
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2016
- Last updated
- 22 Jul 2022
- Results posted
- No
Publications
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.
PubMed 38271925
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy
- ClinicalTrials.gov ID
- NCT02711969
- Acronym / sponsor ID
- BK-AM-GC102
- Conditions
- Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 17 Mar 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib mesylate | Experimental | Drug: Apatinib mesylate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 19 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
Key exclusion criteria (27 listed)
- 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
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 |
|---|---|---|
| Apatinib mesylate1,000mg Apatinib mesylate p.o. qd | Drug | Apatinib mesylate |
Primary outcome
Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
Time frame: First 28 days of dosing
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
2 secondary outcomes
Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities
Time frame: 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)
Time frame: From date of registration to time of first progressive disease(PD) or death, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38271925Kang 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.
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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.
Yoon-Koo Kang, PhD principal investigator
Seoul Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib mesylate in people with Gastric Cancer, run by Bukwang Pharmaceutical at 1 site in South Korea.
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 10 inclusion and 27 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: finished, as of the sponsor's last update on 22 Jul 2022. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer (time frame: First 28 days of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711969, which also lists 1 linked publication.
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 22 Jul 2022.