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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422445
Recruitment Status : Unknown
Verified January 2018 by Jun Guo, Peking University Cancer Hospital & Institute.
Recruitment status was:  Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Guo, Peking University Cancer Hospital & Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 8, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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 Name: Apatinib mesylate tablets

Drug: Temozolomide
Temozolomide：300mg/d，qd，po，d1-5


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival（PFS） [ Time Frame: 12 months ]
    PFS is evaluated in 12 months since the treatment began


Secondary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: 12 months ]
    evaluated in the 12th month since the treatment began

  2. Disease Control Rate(DCR) [ Time Frame: 12 months ]
    evaluated in the 12th month since the treatment began

  3. Overall Survival(OS) [ Time Frame: 12 months ]
    evaluated in the 12th month since the treatment began

  4. Safety and Tolerability as measured by adverse events [ Time Frame: 12 months ]
    Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.03


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422445


Contacts
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Contact: Chuanliang Cui, MD 010-88196317 1008ccl@163.com
Contact: Jun Guo, MD，PHD 010-88196317 guoj307@126.com

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Jun Guo         
Sponsors and Collaborators
Peking University Cancer Hospital & Institute
Investigators
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Principal Investigator: Jun Guo, MD，PHD Peking University Cancer Hospital & Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jun Guo, Director of department of renal cancer and melanoma, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT03422445    
Other Study ID Numbers: AHEAD-MEHB002
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Guo, Peking University Cancer Hospital & Institute:
Apatinib
Temozolomide
Advanced Melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Temozolomide
Apatinib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors