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

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03422445

Collaborator

(none)

Enrollment

Location

Arm

12.8

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Melanoma	Drug: Apatinib Drug: Temozolomide	Phase 2

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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study of Apatinib Combined With Temozolomide in the Treatment of Advanced Melanoma Patients After Conventional Treatment Failure

Actual Study Start Date :

Jan 8, 2018

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apatinib plus Temozolomide this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,apatinib+temozolomide.	Drug: Apatinib Apatinib：500mg/d，qd，po，d1-28 Other Names: Apatinib mesylate tablets Drug: Temozolomide Temozolomide：300mg/d，qd，po，d1-5

Arm

Intervention/Treatment

Experimental: Apatinib plus Temozolomide

this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,apatinib+temozolomide.

Drug: Apatinib

Apatinib：500mg/d，qd，po，d1-28

Other Names:

Apatinib mesylate tablets

Drug: Temozolomide

Temozolomide：300mg/d，qd，po，d1-5

Outcome Measures

Primary Outcome Measures

Progression Free Survival（PFS） [12 months]
PFS is evaluated in 12 months since the treatment began

Secondary Outcome Measures

Objective Response Rate(ORR) [12 months]
evaluated in the 12th month since the treatment began
Disease Control Rate(DCR) [12 months]
evaluated in the 12th month since the treatment began
Overall Survival(OS) [12 months]
evaluated in the 12th month since the treatment began
Safety and Tolerability as measured by adverse events [12 months]
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.