NCT03422445

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

January 30, 2018

Last Update Submit

January 30, 2018

Conditions

Advanced Melanoma

Keywords

ApatinibTemozolomideAdvanced Melanoma

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival（PFS）

    PFS is evaluated in 12 months since the treatment began

    12 months

Secondary Outcomes (4)

  • Objective Response Rate(ORR)

    12 months

  • Disease Control Rate(DCR)

    12 months

  • Overall Survival(OS)

    12 months

  • Safety and Tolerability as measured by adverse events

    12 months

Study Arms (1)

Apatinib plus Temozolomide

EXPERIMENTAL

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

Drug: ApatinibDrug: Temozolomide

Interventions

ApatinibDRUG

Apatinib：500mg/d，qd，po，d1-28

Also known as: Apatinib mesylate tablets
Apatinib plus Temozolomide
TemozolomideDRUG

Temozolomide：300mg/d，qd，po，d1-5

Apatinib plus Temozolomide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35190519DERIVED

MeSH Terms

Interventions

apatinibTemozolomide

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jun Guo, MD，PHD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuanliang Cui, MD

CONTACT

010-881963171008ccl@163.com

Jun Guo, MD，PHD

CONTACT

010-88196317guoj307@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of renal cancer and melanoma

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

January 8, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)