Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：25mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：50mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：100mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：150mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：200mg; multiple dose phase

Drug:XY0206;Dosage form:Tablet;Dosage：250mg; multiple dose phase

Dosage form: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 withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.

XY0206

wei Wang, master

Jianxiang Wang, MD

Junyuan Qi, MD

1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML;
2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects.
3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects;
4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients;
5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.

A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia

A Multicenter, Open, Dose Increasing Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Primary Efficacy of xy0206 Tablets in Relapsed / Refractory Acute Myeloid Leukemia Subjects

The occurrence of Maximum tolerable dose.

The occurrence of Dose limiting toxicity.

The occurrence rate of adverse drug reactions.

The occurrence rate of Serious adverse events.

Check whether the red blood cell system, white blood cell system and platelet system are normal

Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.

Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.

The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected

Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.

To evaluate the electrophysiological condition of the heart

Assess whether systolic blood pressure and diastolic blood pressure are normal

Head examination includes head, eyes, ears, nose, lips, etc.Assess if head is normal

Neck examination includes thyroid gland, lymph node, etc.Assess if neck is normal.

Chest examination includes lung, cardiovascular, etc.Assess if chest is normal.

Abdominal examination includes liver and spleen.Assess if abdomen is normal.

Proswell Medical Corporation

Shijiazhuang Yiling Pharmaceutical Co. Ltd

All Drugs and Chemicals

Tin Fluorides

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

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

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

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

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

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

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.

wei wang, master

binghe xu, MD

Jinsheng Wu, MD

Da Jiang, MD

Zhanyu Pan, MD

Binghe Xu, MD

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

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

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

The occurrence rate of adverse drug reactions(ADR).

area under the concentration-time curve from the time of dosing extrapolated to time infinity.

area under the concentration-time curve from the time of dosing extrapolated to the 24h after dosing.

area under the concentration-time curve from the time of dosing extrapolated to the 72h after dosing.

area under the concentration-time curve from the time of dosing extrapolated to the 120h after dosing.

The amount of time that a drug is present at the maximum concentration in serum.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia	NCT04471064	Acute Myeloid L...	XY0206	18 Years -	Shijiazhuang Yiling Pharmaceutical Co. Ltd
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours	NCT03658070	Advanced or Met...	XY0206	18 Years - 70 Years	Shijiazhuang Yiling Pharmaceutical Co. Ltd
A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours	NCT03658070	Advanced or Met...	XY0206	18 Years - 70 Years	Shijiazhuang Yiling Pharmaceutical Co. Ltd

Spots Global Cancer Trial Database for xy0206

Every month we try and update this database with for xy0206 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xy0206

Every month we try and update this database with for xy0206 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xy0206 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.