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

Peking University Cancer Hospital & Institute

Status and phase

Unknown

Phase 2

Conditions

Advanced Melanoma

Treatments

Drug: Temozolomide

Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03422445

AHEAD-MEHB002

Details and patient eligibility

About

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

Full 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, 500 mg, qd, po, d1-28, Every 28 days for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. So we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.