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

NCT ID: NCT03422445

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2019-02-28

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, 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.

Conditions

Advanced Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib plus Temozolomide

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

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib：500mg/d，qd，po，d1-28

Temozolomide

Intervention Type: DRUG

Temozolomide：300mg/d，qd，po，d1-5

Interventions

Apatinib

Apatinib：500mg/d，qd，po，d1-28

Intervention Type: DRUG

Temozolomide

Temozolomide：300mg/d，qd，po，d1-5

Intervention Type: DRUG

Other Intervention Names

Apatinib mesylate tablets

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Jun Guo

Director of department of renal cancer and melanoma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Guo, MD，PHD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuanliang Cui, MD

Role: CONTACT

1008ccl@163.com

010-88196317

Jun Guo, MD，PHD

Role: CONTACT

guoj307@126.com

010-88196317

Facility Contacts

Jun Guo

Role: primary

References

Zhou L, Yang Y, Si L, Chi Z, Sheng X, Lian B, Wang X, Tang B, Mao L, Yan X, Li S, Bai X, Guo J, Cui C. Phase II study of apatinib combined with temozolomide in patients with advanced melanoma after failure of immunotherapy. Melanoma Res. 2022 Jun 1;32(3):142-149. doi: 10.1097/CMR.0000000000000809. Epub 2022 Feb 20.

Reference Type: DERIVED

PMID: 35190519 (View on PubMed)

Other Identifiers

AHEAD-MEHB002

Identifier Type: -

Identifier Source: org_study_id