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

• ClinicalTrials.gov Identifier: NCT03422445
• Recruitment Status: Unknown
• First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Sponsor: Peking University Cancer Hospital & Institute
• Information provided by (Responsible Party): Jun Guo, Peking University Cancer Hospital & Institute

Tracking Information

• First Submitted Date: January 30, 2018
• First Posted Date: February 5, 2018
• Last Update Posted Date: February 5, 2018
• Actual Study Start Date: January 8, 2018
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2018)

Progression Free Survival（PFS） [ Time Frame: 12 months ]

PFS is evaluated in 12 months since the treatment began

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 30, 2018)

• Objective Response Rate(ORR) [ Time Frame: 12 months ]
  evaluated in the 12th month since the treatment began
• Disease Control Rate(DCR) [ Time Frame: 12 months ]
  evaluated in the 12th month since the treatment began
• Overall Survival(OS) [ Time Frame: 12 months ]
  evaluated in the 12th month since the treatment began
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Melanoma

Intervention

• Drug: Apatinib
  Apatinib：500mg/d，qd，po，d1-28
  Other Name: Apatinib mesylate tablets
• Drug: Temozolomide
  Temozolomide：300mg/d，qd，po，d1-5

Study Arms

Experimental: Apatinib plus Temozolomide

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

Interventions:

• Drug: Apatinib
• Drug: Temozolomide

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 30, 2018): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2019
• Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03422445
• Other Study ID Numbers: AHEAD-MEHB002
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jun Guo, Peking University Cancer Hospital & Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University Cancer Hospital & Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Peking University Cancer Hospital & Institute
• Verification Date: January 2018