Advanced or Metastatic Solid TumoursPhase 1NCT03658070
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours
A Phase 1 study testing XY0206 in people with Advanced or Metastatic Solid Tumours, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 4 sites in China.
Trial summary
1. To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced or Metastatic Solid Tumours
- What is being tested?
- XY0206
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesChina
- Study dates
- 19 Dec 2018to Dec 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria before entering the group:
- Patients with advanced/metastatic solid tumor (such as non-small cell lung cancer, gastrointestinal stromal tumor, renal cell carcinoma, pancreatic cancer, etc.) who have failed standard treatment with histological or cytological diagnosis, have no effective treatment, or have relapsed after treatment.
- Patients with measurable or evaluable tumor lesions (1.1 version of RECIST efficacy evaluation criteria).
- The age is 18~70 years old (including upper and lower limit), and there is no restriction on male and female (for participating in the extended trial)Of patients with a sex ratio of not less than 30%).
- Physical condition ECOG≤2.
- Expected survival ≥3 months.
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- BMI at 19≤BMI≤30, BMI = weight (kg)/height 2 (m2).
- Liver function: AST <2.5×ULN, ALT<2.5×ULN, total bilirubin <1.5×ULN.
- Blood biochemistry: Serum potassium and sodium levels are within the range of normal laboratory values (if researchers and physiciansThe overseer assesses results beyond the normal range to be of no clinical significance and the patient canInto the group; If the drug can be controlled within the normal range during the screening period, the patient canTo enroll).
- Renal function: serum creatinine (Scr) ≤1.5×ULN or calculated creatinine clearance rate(Ccr) >60mL/min Ccr calculation formula: male Ccr=[(140- age)× weight(kg)] / [0.818 x Scr (mu mol/L)], women Ccr = 0.85 x [(140 - age) by weight(kg)] / [0.818 x Scr (mu mol/L)].
- blood routine: platelet count of > 80×109/L, hemoglobin of > 90g/L, neutrophil pair count of > 1.5×109 /L.
- Urine routine: urinary protein - or 1+, or 24-hour urinary protein <1 g [Note: if due to urinary tractTransient abnormalities of the above urinary protein due to infection and other causes returned to normal after retesting.You can also consider enrolling; Subjects without proteinuria symptoms may also be considered for inclusion.
- Coagulation function: International standardized ratio < 1.5.
- No other antitumor concomitant therapy (including steroids with antitumor effects).
- Women of childbearing age and men agreed to use it throughout the study period and within 6 months after completion of treatmentRegular contraception that is effective enough.
- Understand and voluntarily sign written informed consent, and have the willingness and ability to complete regular visits and treatmentTreatment planning, laboratory examination and other test procedures.
Who cannot join
- Patients cannot participate in this clinical study if they meet any of the following conditions:
- Pregnant or lactating women.
- Tested positive for human immunodeficiency virus (HIV).
- The active period of HBV or HCV infection is known to be associated with abnormal liver function, and antiviral drugs are required.
- Severe trauma, ulcer or fracture at screening time.
- A history of uncontrolled epilepsy, central nervous system disease or mental illness.
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- Symptomatic or uncontrolled brain metastases or meningeal diseases.
- diabetes or hypertension with poor drug control (under optimal drug treatment, fasting blood glucose >7mmol/L, or blood pressure > 150/100mmhg).
- Uncontrolled thyroid dysfunction.
- Persistent arrhythmias of version 4.03 or above, NCI CTCAE level ≥2, atrial fibrillation of any level.
- Cardiac ejection fraction (ECHOcardiography) below 50%.
- patients with clinically significant prolonged history of QTc (>450ms for male and >470ms for female).
- Have a history of severe drug allergy (NCI CTCAE level ≥3 according to version 4.03 or above) and may be allergic to test drug ingredients; Has been treated with or is allergic to sunitinib malate.
- for the first time to give medicine taken within 4 weeks before have significant effects on P450 metabolic pathway of drugs (for example: ketoconazole, itraconazole, clarithromycin, aza that wei, indiana that wei, naphthalene sanzuotong, that of the wei and the wey, ShaKui the wey, terry toxin, voriconazole, dexamethasone, phenytoin, carbamazepine, rifampicin, dean, rifampicin and dean at the cloth, phenobarbital, st. John's wort, etc.) or to eat within 48 h before delivery of P450 metabolic enzyme pathways have a significant impact on food (such as grapefruit and food containing grapefruit).
- Received any experimental drug therapy within 6 weeks prior to initial administration.
- for the first time six weeks before the treatment, patients treated with anti-tumor therapy (chemotherapy, radiation therapy, biological therapy, or hormone therapy) (note: for anti-tumor small molecules targeting drugs, if the patient before the first test drugs, always use small molecules targeting drug has cleared more than 5 half-life, the patient may also be considered into the group]. Surgery was performed within 14 weeks prior to the first administration.
- patients have any limit test compliance of medical or psychiatric conditions, such as the central nervous system (CNS) leukemia, active control of bacterial infection, 3, or 4 bleeding, unstable angina, myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, or into the group of six months before the test of catheter-related deep vein thrombosis, insulin-dependent diabetes mellitus (namely, type 1 diabetes), or non insulin-dependent diabetes but there were signs of small vascular disease, Adrenocortical dysfunction is known, malabsorption syndrome is known, and active autoimmune diseases are known.
- Other severe acute or chronic medical or psychiatric conditions, or laboratory test abnormalities that may exacerbate the risks associated with participating in or taking test drugs, or that may interfere with the interpretation of test results. These conditions or abnormalities may be determined by the investigator to make the patient unfit to participate in the trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
binghe xu, MD, 086-010-87788826, xubinghe@medmail.com.cn
binghe xu, MD
- Not yet recruiting
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, 570102
Jinsheng Wu, MD, 086-13707599070, wjs7911@126.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Da Jiang, MD, 086-13933191980, jiangda139@163.com
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Zhanyu Pan, MD, 086-13820583299, tjpanzhanyu@medmail.com.cn
About this study
Official title: A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours
- To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans.
- To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies;
- To evaluate the effect of standard meal on main PK parameters of XY0206;
- To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
- To explore the correlation between PK and QTcF.
- Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.
- Conditions
- Advanced or Metastatic Solid Tumours
- Being tested
- XY0206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XY0206Drug
Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose.
| Study group | Role | What they receive |
|---|---|---|
| XY0206-12.5mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
| XY0206-25mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：25mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
| XY0206-37.5mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：37.5mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
| XY0206-50mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：50mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
| XY0206-75mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：75mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
| XY0206-100mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：100mg;Include single dose treatment and multiple dose phase Receives: Drug: XY0206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
The occurrence of DLT.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
AE
The occurrence rate of AE.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
ADR
The occurrence rate of adverse drug reactions(ADR).
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
SAE
The occurrence rate of SAE.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood routine
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Urine routine
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Stool routine
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood biochemistry
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Coagulation function
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
12 lead ecg
One of the laboratory tests.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Body temperature
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood pressure
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Heart rate
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Breathing
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
General condition
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Skin
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Head
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Eyes
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Ears
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Nose
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Throat
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Heart
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Lung
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Chest
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Abdomen
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Limbs
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Nerves
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Back/spine
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Lymph nodes
One of the physical examination.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Secondary outcomes (29)
AUCinf
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC0-24h
area under the concentration-time curve from the time of dosing extrapolated to the 24h after dosing.
Measured: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
AUC0-72h
area under the concentration-time curve from the time of dosing extrapolated to the 72h after dosing.
Measured: single dose phase:up to 72 hours
AUC0-120h
area under the concentration-time curve from the time of dosing extrapolated to the 120h after dosing.
Measured: single dose phase:up to 120 hours
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
CL/F
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Tmax
The amount of time that a drug is present at the maximum concentration in serum.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmin,ss
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmax,ss
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cav,ss
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
PTF
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC1
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC2
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RCmax
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Kel
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
t1/2
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Vz/F
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC_%Extrap
The PK parameters of the plasma sample.
Measured: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Ae0-24h
The PK parameters of the plasma sample.
Measured: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Fe0-24h
The PK parameters of the plasma sample.
Measured: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Ae0-72h
The PK parameters of the plasma sample.
Measured: single dose phase:up to 72 hours
Fe0-72h
The PK parameters of the plasma sample.
Measured: single dose phase:up to 72 hours
Ae0-72h stool
The PK parameters of the plasma sample.
Measured: single dose phase:up to 72 hours
CLr
The PK parameters of the plasma sample.
Measured: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Exploring the relative baseline change percentage of biomarkers (soluble VEGFR2).
The PD parameters of XY0206.
Measured: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Complete response rate (CRR)
Effective parameters of XY0206.
Measured: through study completion,such as 30 months.
Partial response rate (PRR)
Effective parameters of XY0206.
Measured: through study completion,such as 30 months.
Objective response rate (ORR)
Effective parameters of XY0206.
Measured: through study completion,such as 30 months.
Progression-free survival (PFS)
Effective parameters of XY0206.
Measured: through study completion,such as 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start19 Dec 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumoursStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658070
- Sponsor's protocol ID
- XY0206ONC1001
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2018
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT03658070
- Acronym / sponsor ID
- XY0206ONC1001
- Conditions
- Advanced or Metastatic Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Sep 2018 (actual)
- 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.
- To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans.
- To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies;
- To evaluate the effect of standard meal on main PK parameters of XY0206;
- To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
- To explore the correlation between PK and QTcF.
- Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| XY0206-12.5mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg;Include single dose treatment and multiple dose phase |
| XY0206-25mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：25mg;Include single dose treatment and multiple dose phase |
| XY0206-37.5mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：37.5mg;Include single dose treatment and multiple dose phase |
| XY0206-50mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：50mg;Include single dose treatment and multiple dose phase |
| XY0206-75mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：75mg;Include single dose treatment and multiple dose phase |
| XY0206-100mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：100mg;Include single dose treatment and multiple dose phase |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must meet all of the following criteria before entering the group:
Key exclusion criteria (18 listed)
- Patients cannot participate in this clinical study if they meet any of the following conditions:
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 |
|---|---|---|
| XY0206Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose. | Drug | XY0206-100mg, XY0206-12.5mg, XY0206-25mg, XY0206-37.5mg, XY0206-50mg, XY0206-75mg |
Primary outcome
DLT
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence of DLT.
AE
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of AE.
ADR
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of adverse drug reactions(ADR).
SAE
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of SAE.
Blood routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
Urine routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
Stool routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
Blood biochemistry
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
Coagulation function
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
12 lead ecg
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the laboratory tests.
Body temperature
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
Blood pressure
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
Heart rate
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
Breathing
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
General condition
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Skin
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Head
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Eyes
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Ears
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Nose
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Throat
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Heart
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Lung
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Chest
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Abdomen
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Limbs
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Nerves
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Back/spine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
Lymph nodes
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the physical examination.
29 secondary outcomes
AUCinf
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC0-24h
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
AUC0-72h
Time frame: single dose phase:up to 72 hours
AUC0-120h
Time frame: single dose phase:up to 120 hours
Peak Plasma Concentration (Cmax)
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
CL/F
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Tmax
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmin,ss
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cmax,ss
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Cav,ss
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
PTF
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC1
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RAUC2
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
RCmax
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Kel
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
t1/2
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Vz/F
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
AUC_%Extrap
Time frame: single dose phase:up to 120 hours;multiple dose phase:up to 24 hours
Ae0-24h
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Fe0-24h
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Ae0-72h
Time frame: single dose phase:up to 72 hours
Fe0-72h
Time frame: single dose phase:up to 72 hours
Ae0-72h stool
Time frame: single dose phase:up to 72 hours
CLr
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Exploring the relative baseline change percentage of biomarkers (soluble VEGFR2).
Time frame: single dose phase:up to 24 hours;multiple dose phase:up to 24 hours
Complete response rate (CRR)
Time frame: through study completion,such as 30 months.
Partial response rate (PRR)
Time frame: through study completion,such as 30 months.
Objective response rate (ORR)
Time frame: through study completion,such as 30 months.
Progression-free survival (PFS)
Time frame: through study completion,such as 30 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Binghe Xu, MD principal investigator
Chinese Academy of Medical Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XY0206 in people with Advanced or Metastatic Solid Tumours, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 4 sites in China.
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 16 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei wang, master (086-0311-66703017, wangwei001@yiling.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: from the start of the medication to the end of the study or 28 days after cessation of medication). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2020.