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

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

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

Study Overview

• Status: Unknown
• Conditions: Advanced Melanoma
• Intervention / Treatment: Drug: Apatinib; Drug: Temozolomide

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Jun Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival（PFS）	PFS is evaluated in 12 months since the treatment began	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jun Guo, MD,PHD, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Temozolomide; Apatinib; Advanced Melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Protein Kinase Inhibitors; Temozolomide; Apatinib
• Other Study ID Numbers: AHEAD-MEHB002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No