Status:
UNKNOWN
A Study of Apatinib Combined With Temozolomide in Patients Witn Advanced Melanoma
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.
Detailed Description
In this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. The therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03422445
Start Date
January 8 2018
End Date
February 1 2019
Last Update
February 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Cancer Hospital
Beijing, China