Cancer Patients With Solid TumorsPhase 1/2NCT01497704
Dose-Escalation and Safety Trial of YN968D1
A Phase 1/2 study testing YN968D1 in people with Cancer Patients With Solid Tumors, run by Elevar Therapeutics at 2 sites in 2 countries.
Trial summary
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients With Solid Tumors
- What is being tested?
- YN968D1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2012to May 2015
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Subjects may be enrolled with the following malignancies:
- Part 1: Subjects with any solid malignant tumor that are refractory to conventional therapy or the subject does not tolerate the conventional therapy
- Part 2: Subjects diagnosed with NSCLC, CRC, RCC, Gastric cancer, GIST or triple negative Breast Cancer that are refractory to conventional therapy or the subject does not tolerate the conventional therapy
- Evaluable disease defined by RECIST 1.1 as measured by a suitable imaging technique
- Life expectancy ≥ 3 months
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- Subject must be suitable for oral administration of study medication
- Signed written informed consent
- Adequate bone marrow, renal, and liver function as manifested by the following:
- CBC: ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0 g/dL
- CMP: Creatinine clearance > 50 mL/min or serum creatinine < 1.5 x ULN, serum bilirubin < 2.5 x ULN, AST and ALT ≤ 5.0 × ULN
- Coagulation profile with PT and INR, each ≤ 1.5 x ULN
- Proteinuria < 200 mg by 24- hour urine collection without evidence of active sediment or hematuria
- ECOG performance status ≤ 2
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of YN968D1 until 4 weeks after discontinuing study drug and male subjects must agree to use contraceptive measures during the study and ending 4 weeks after last dose of study drug
- Female patients of child-bearing potential are confirmed to have either a negative serum ß-hCG test, or have been evaluated by a gynecologist to confirm the patient is not pregnant, within 7 days prior to administration of initial dose of YN968D1
- Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures
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 that may prevent clotting and in the opinion of the investigator would place the subject at risk.
- Hemoptysis within 3 months prior to first scheduled dose of YN968D1
- Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
- Surgery or visceral (e.g., hepatic or renal) biopsy within 28 days prior to first scheduled dose of YN968D1
- Minor surgical procedure performed within 7 days prior to first scheduled dose of YN968D1
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- Prior exposure to YN968D1 (prior treatment with an angiogenesis inhibitor is not exclusionary)
- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.
- Known history of human immunodeficiency virus infection (HIV)
- Subjects with active bacterial infections and/or receiving systemic antibiotics
- Current or past diagnosis of leukemia within the past 5 years
- Prior radiotherapy at the target lesion
- Known CNS metastases or clinical evidence of CNS involvement that is not stable for last 3 months by radiology documentation
- Medical history of non-healing wound within past 2 weeks
- 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 that in the opinion of the investigator may place the patient at risk of side effects on an anti-angiogenesis product
- History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months that in the opinion of the investigator may place the patient at risk of side effects on an anti-angiogenesis product
- History of idiopathic or hereditary angioedema
- History of sickle cell or any hemolytic anemia
- History of uncontrolled hypertension that in the opinion of the investigator is not well managed by medication and may place the patient at risk when taking a VEGF inhibitor
- Complete left bundle branch block (LBBB), bifascicular block (RBBB with either left anterior hemiblock or left posterior hemiblock)
- Any clinically significant ST segment and/or T-wave abnormalities
- Presence of unstable atrial fibrillation (ventricular response rate > 100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet another exclusion criteria
- 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 vesicular disease within the last 6 months (e.g. such as hypertensive crisis, hypertensive encephalopathy, stroke or TIA, or significant peripheral vascular disease) that in the opinion of the investigator may place the patient at risk when taking a VEGF inhibitor
- History of significant gastrointestinal disorders that in the opinion of the investigator may place the patient at risk when taking a VEGF inhibitor; such as an abdominal fistula, GI perforation, or bleeding ulcer within 2 months of treatment
- QTcF >450 msec on screening ECG
- Baseline echocardiogram (within 2 months) with left ventricular ejection fraction (LVEF) <50%
- History of clinically significant glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies
- History of myocardial infarction within the past 6 months
- Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
- Medical or psychiatric illness that, in the opinion of the Investigator, may impact the safety of the subject or objectives of the study
- 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
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Evaluation of the Safety, Pharmacokinetics and Efficacy of Four Doses of YN968D1 in Subjects With Solid Tumors
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.
Read the detailed description
Part 1 will include a sequential evaluation of 3 subjects per cohort; cohort 1 at a dose of 100 mg YN968D1, followed by a cohorts 2, 3 and 4 at doses of 250 mg, 500 mg and 750 mg respectively. Initially, each subject will receive one dose of YN968D1 followed by a 7-Day observation period, during which single dose PK assessments and safety monitoring will be performed. If the initial dose is well tolerated, the subject will return on Day 8 and receive 28-Days of continuous YN968D1 oral administration daily. Each subject will subsequently be assessed for safety and disease progression on Day 35±2 and steady state pharmacokinetic sampling will be obtained. Patients may continue on therapy for an additional 28-Day cycles without dose interruption if the therapy is well tolerated. Efficacy assessments (biomarkers) and disease progression (RECIST imaging) will be assessed every two 28-Day cycles. The subjects will be assessed for safety for at least 28-Days after the last dose of YN968D1.
For Part 1 of this study, a Dose Limiting Toxicity (DLT) event is defined as any of the following events that are assessed by the Investigator as probably or possibly related to YN968D1 and occur during or after the initial dose on Day 1 through Day 35 of the first cycle of therapy.
- CTCAE Grade 4 event
- Grade 3 febrile neutropenia (<1,000 neutrophils/mL)
- Grade 3 hematologic toxicity with duration > 7 days
- Grade 3 non-hematologic toxicity (except for nausea, vomiting, diarrhea that continues despite optimal medical management)
If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If two (2) DLTs are experienced in any cohort, the study will be paused until the safety events are evaluated and discussed with the FDA to determine if the trial may continue.
Part 2 of this study will include up to 30 subjects. Each subject will receive a 750 mg dose or the maximum tolerated dose of YN968D1 from part 1 of the study for continuous 28-Day cycles of therapy. If a subject experiences an intolerable side effect a dose reduction or a dose interruption for up to 7-Days is allowed at the discretion of the investigator. Subjects will be evaluated for RECIST (version 1.1) response at the end of the second cycle of therapy on Day 56±3 of the Part 2 study. Safety reporting will be continued for 28-Days from the last dose of study medication.
All subjects in Part 1 and 2 of this trial will be eligible to continue therapy provided they have a least stable disease or better and are, in the opinion of the investigator, adequately tolerating treatment with YN968D1.
- Conditions
- Cancer Patients With Solid Tumors
- Being tested
- YN968D1
- Keywords
- Cancer, Tumor, Oncology, Antiangiogenesis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YN968D1Drug
Also called Apatinib
Daily dosing of YN968D1 for treatment of solid tumors
| Study group | Role | What they receive |
|---|---|---|
| YN968D1 | Experimental | Active therapy arm for safety evaluation Receives: Drug: YN968D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in the first 28-Days of Therapy
The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of YN968D1. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology (including RBC morphology and reticulocyte count), and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for creatinine clearance and protein), and electrocardiograms (ECGs) in triplicate.
Measured: 28-Days after Discontinuation of YN968D1
Secondary outcomes (3)
Pharmacokinetic Assessments for AUC, Cmax and Tmax
In Part 1 of this study, full PK profiles of YN968D1 will be obtained following administration of a single oral dose of YN968D1 on Day 1, and at steady state on Day 35±2. In Part 2 of this study, PK sampling will include a pre-dose and at the 4±1 hour time point on the first day of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2, 7, 14 and 28 of the first 28-Day cycle of therapy
Measured: Day 1 Single Dose and Day 28 Steady State
Tumor Biomarkers for Specific Tumor Types
The primary Pharmacodynamic endpoints will include specific serum tumor markers for the target cancer, levels of endothelial growth factor (VEGF), and detection of EC-derived molecules such as sVEGFR-1, sVEGFR-2, sVEGFR-3, sTie-2 and VCAM-1, as well as PIGF. These biomarkers will be measured at baseline and at the end of every two 28-Day cycles of therapy. For patients that continue on repeat 28-Day cycles after the primary evaluation period, biomarkerts will be assessed after each two 28-Day cycles of therapy.
Measured: Every 28-Days
Objective Response Rate (RESIST)
Anti-tumoral efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) at baseline (Day -14 to -1) and at the end of two 28-Day cycles of therapy (Part 1 - Day 35±2; or Part 2 56±2 Days). For patients that continue on repeat 28-Day cycles after the primary evaluation period, progression will be assessed after each two 28-Day cycles of therapy.
Measured: Every 56-Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionFeb 2015
- Study completionMay 2015
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 Cancer Patients With Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elevar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Sunil Sharma, MD, FACP, Principal investigator, Huntsman Cancer InstituteYoon-Koo Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497704
- Sponsor's protocol ID
- BK-LSK-AM101
- Status last verified
- Sep 2017
- First submitted
- 18 Dec 2011
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Pharmacokinetics and Efficacy of Four Doses of YN968D1 in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01497704
- Acronym / sponsor ID
- BK-LSK-AM101
- Conditions
- Cancer Patients With Solid Tumors
- Keywords
- Cancer, Tumor, Oncology, Antiangiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Elevar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Dec 2011 (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.
This protocol will be divided into two parts: Part 1 will evaluate the safety and pharmacokinetics of three doses of YN968D1 after a single administration followed by a 28-Day continuous course of therapy; Part 2 will evaluate the safety and preliminary efficacy in an open-label administration of YN968D1 at the MTD or a maximum of 750 mg. All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if the product is well tolerated and the subject has stable disease or better. Up to 72 subjects will be enrolled in this clinical trial.
Detailed description
Part 1 will include a sequential evaluation of 3 subjects per cohort; cohort 1 at a dose of 100 mg YN968D1, followed by a cohorts 2, 3 and 4 at doses of 250 mg, 500 mg and 750 mg respectively. Initially, each subject will receive one dose of YN968D1 followed by a 7-Day observation period, during which single dose PK assessments and safety monitoring will be performed. If the initial dose is well tolerated, the subject will return on Day 8 and receive 28-Days of continuous YN968D1 oral administration daily. Each subject will subsequently be assessed for safety and disease progression on Day 35±2 and steady state pharmacokinetic sampling will be obtained. Patients may continue on therapy for an additional 28-Day cycles without dose interruption if the therapy is well tolerated. Efficacy assessments (biomarkers) and disease progression (RECIST imaging) will be assessed every two 28-Day cycles. The subjects will be assessed for safety for at least 28-Days after the last dose of YN968D1.
For Part 1 of this study, a Dose Limiting Toxicity (DLT) event is defined as any of the following events that are assessed by the Investigator as probably or possibly related to YN968D1 and occur during or after the initial dose on Day 1 through Day 35 of the first cycle of therapy.
- CTCAE Grade 4 event
- Grade 3 febrile neutropenia (<1,000 neutrophils/mL)
- Grade 3 hematologic toxicity with duration > 7 days
- Grade 3 non-hematologic toxicity (except for nausea, vomiting, diarrhea that continues despite optimal medical management)
If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If two (2) DLTs are experienced in any cohort, the study will be paused until the safety events are evaluated and discussed with the FDA to determine if the trial may continue.
Part 2 of this study will include up to 30 subjects. Each subject will receive a 750 mg dose or the maximum tolerated dose of YN968D1 from part 1 of the study for continuous 28-Day cycles of therapy. If a subject experiences an intolerable side effect a dose reduction or a dose interruption for up to 7-Days is allowed at the discretion of the investigator. Subjects will be evaluated for RECIST (version 1.1) response at the end of the second cycle of therapy on Day 56±3 of the Part 2 study. Safety reporting will be continued for 28-Days from the last dose of study medication.
All subjects in Part 1 and 2 of this trial will be eligible to continue therapy provided they have a least stable disease or better and are, in the opinion of the investigator, adequately tolerating treatment with YN968D1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YN968D1 | Experimental | Drug: YN968D1Active therapy arm for safety evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years of age or older
- Subjects may be enrolled with the following malignancies:
- Evaluable disease defined by RECIST 1.1 as measured by a suitable imaging technique
- Life expectancy ≥ 3 months
- Subject must be suitable for oral administration of study medication
Key exclusion criteria (35 listed)
- Pregnant or lactating women
- Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of YN968D1 that may prevent clotting and in the opinion of the investigator would place the subject at risk.
- Hemoptysis within 3 months prior to first scheduled dose of YN968D1
- Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
- Surgery or visceral (e.g., hepatic or renal) 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 |
|---|---|---|
| YN968D1Also: ApatinibDaily dosing of YN968D1 for treatment of solid tumors | Drug | YN968D1 |
Primary outcome
Safety in the first 28-Days of Therapy
Time frame: 28-Days after Discontinuation of YN968D1
The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of YN968D1. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology (including RBC morphology and reticulocyte count), and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for creatinine clearance and protein), and electrocardiograms (ECGs) in triplicate.
3 secondary outcomes
Pharmacokinetic Assessments for AUC, Cmax and Tmax
Time frame: Day 1 Single Dose and Day 28 Steady State
Tumor Biomarkers for Specific Tumor Types
Time frame: Every 28-Days
Objective Response Rate (RESIST)
Time frame: Every 56-Days
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 2 Oct 2017.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Sunil Sharma, MD, FACP principal investigator
Huntsman Cancer Institute
Yoon-Koo Kang, MD, PhD principal investigator
Asan Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YN968D1 in people with Cancer Patients With Solid Tumors, run by Elevar Therapeutics at 2 sites in 2 countries.
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 17 inclusion and 35 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety in the first 28-Days of Therapy (time frame: 28-Days after Discontinuation of YN968D1). 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 NCT01497704, 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 2 Oct 2017.