A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

NCT03658070 | Unknown Phase 1

• 1 other identifier: XY0206ONC1001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

1. 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. 2.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;
3. 3.To evaluate the effect of standard meal on main PK parameters of XY0206;
4. 4.To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor.
5. 5.To explore the correlation between PK and QTcF.
6. 6.Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.

Conditions

Advanced or Metastatic Solid Tumours

Outcome Measures

Primary Outcomes (29)

• DLT

  The occurrence of DLT.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  from the start of the medication to the end of the study or 28 days after cessation of medication

Secondary Outcomes (29)

• AUCinf

  single dose phase:up to 120 hours;multiple dose phase:up to 24 hours

• AUC0-24h

  single dose phase:up to 24 hours;multiple dose phase:up to 24 hours

• AUC0-72h

  single dose phase:up to 72 hours

• AUC0-120h

  single dose phase:up to 120 hours

• Peak Plasma Concentration (Cmax)

  single dose phase:up to 120 hours;multiple dose phase:up to 24 hours

Study Arms (6)

XY0206-12.5mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg;Include single dose treatment and multiple dose phase

Drug: XY0206

XY0206-25mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：25mg;Include single dose treatment and multiple dose phase

Drug: XY0206

XY0206-37.5mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：37.5mg;Include single dose treatment and multiple dose phase

Drug: XY0206

XY0206-50mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：50mg;Include single dose treatment and multiple dose phase

Drug: XY0206

XY0206-75mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：75mg;Include single dose treatment and multiple dose phase

Drug: XY0206

XY0206-100mg

EXPERIMENTAL

Drug:XY0206;Dosage form:Tablet;Dosage：100mg;Include single dose treatment and multiple dose phase

Drug: XY0206

Interventions

XY0206 DRUG

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.

XY0206-100mg; XY0206-12.5mg; XY0206-25mg; XY0206-37.5mg; XY0206-50mg; XY0206-75mg

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (4)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, 570102, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Study Officials

• Binghe Xu, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei wang, master

CONTACT

086-0311-66703017; wangwei001@yiling.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: September 5, 2018
• Study Start: December 19, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)