Spots Global Cancer Trial Database for A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT03658070

Conditions

Advanced or Metastatic Solid Tumours

Interventions

XY0206

Study Description

Brief 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. 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.

Detailed Description: