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

Primary Purpose

Advanced Melanoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

Temozolomide

About this trial

This is an interventional treatment trial for Advanced Melanoma focused on measuring Apatinib, Temozolomide, Advanced Melanoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib plus Temozolomide

Arm Description

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

Outcomes

Primary Outcome Measures

Progression Free Survival（PFS）

PFS is evaluated in 12 months since the treatment began

Secondary Outcome Measures

Objective Response Rate(ORR)

evaluated in the 12th month since the treatment began

Disease Control Rate(DCR)

evaluated in the 12th month since the treatment began

Overall Survival(OS)

evaluated in the 12th month since the treatment began

Safety and Tolerability as measured by adverse events

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.03

Full Information

NCT ID

NCT03422445

First Posted

January 30, 2018

Last Updated

January 30, 2018

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03422445

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 8, 2018 (Actual)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Melanoma

Keywords

Apatinib, Temozolomide, Advanced Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib plus Temozolomide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

Apatinib mesylate tablets

Intervention Description

Apatinib：500mg/d，qd，po，d1-28

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Temozolomide：300mg/d，qd，po，d1-5

Primary Outcome Measure Information:

Title

Progression Free Survival（PFS）

Description

PFS is evaluated in 12 months since the treatment began

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Description

evaluated in the 12th month since the treatment began

Time Frame

12 months

Title

Disease Control Rate(DCR)

Description

evaluated in the 12th month since the treatment began

Time Frame

12 months

Title

Overall Survival(OS)

Description

evaluated in the 12th month since the treatment began

Time Frame

12 months

Title

Safety and Tolerability as measured by adverse events

Description

Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.03

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chuanliang Cui, MD

Phone

010-88196317

1008ccl@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Guo, MD，PHD

Phone

010-88196317

guoj307@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, MD，PHD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Guo

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35190519

Citation

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.

Results Reference

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

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