A Study of Apatinib Combined With Temozolomide in Patients Witn Advanced Melanoma

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Apatinib; Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Age 18-70 years old；

• ECOG performance scale 0-1；

• Life expectancy of more than 3 months；

• Histologically or cytologic confirmed melanoma；

• Temozolomide has not been previously treated；

• Patients who have failed at least one systemic treatment regimen： including but not limited to patients receiving immunotherapeutics such as PD-1 monoclonal antibodies, PDL-1 monoclonal antibodies, ipilimumab, C-kit inhibitors, Braf inhibitors, and molecular targeted drugs.

• For results of blood routine test and biochemical tests： Hgb>100g/L, ANC>2.0×109/L, PLT>100×109/L, Serum Total bilirubin ≤ 1.5 X UNL, ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）, Serum Creatine ≤ 1.5 x UNL；

• Informed consent；

• Willingness and ability to comply with scheduled visits.

Exclusion Criteria:

• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)；

• With ≥grade 2 coronary heart disease, arrhythmia (including QTc interval prolongation male ≥450 ms, women ≥470 ms)；

• Imaging studies have shown that the tumor has been infringing on an important perivascular or when the researcher determines that the patient's tumor has a high risk of fatal hemorrhage during treatment；

• Abnormal Coagulation (INR>1.5, PT>UNL+4 seconds), with tendency of bleed or receiving the therapy of thrombolysis or anticoagulation.；

• Urine protein ≥++ or confirmed >1.0 g by the 24h quantity；

• Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures；

• A history of psychotropic substance abuse and can not be abstinent or mental disorders ；

• There are serious concomitant diseases that endanger patient safety or affect the patient in completing the study；

• Patients participating in other clinical trials simultaneously；

• Other situations that the researchers considered unsuitable for this study；

• Confirmed brain metastasis.