NCT02848794

Brief Summary

The study is aimed to evaluate the efficacy and safety of Apatinib and Irinotecan in patients with recurrent high-grade glioma.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

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

July 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

July 22, 2016

Last Update Submit

June 14, 2017

Conditions

High-grade Glioma

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)

    From enrollment to progression of disease. Estimated about 6 months

Secondary Outcomes (6)

  • Overall Survival (OS)

    From enrollment to death of patients. Estimated about 1 year

  • Objective Response Rate (ORR)

    From enrollment to 2 months after treatment

  • Disease Control Rate (DCR)

    From enrollment to 2 months after treatment

  • Duration of Response（DOR）

    From first documented CR or PR until disease progression or death(up to 1 year)

  • Quality of life (QOL)

    up to 1 year

  • +1 more secondary outcomes

Study Arms (1)

Apatinib+Irinotecan

EXPERIMENTAL

Apatinib and irinotecan in treating patients with recurrent high-grade glioma,who have progressed on temozolomide, or radiotherapy alone, or combined with chemotherapy within 3 months after surgery .

Drug: Apatinib and Irinotecan

Interventions

Apatinib and IrinotecanDRUG

Patients were administered at apatinib (850mg po qd) and irinotecan(125mg/m2 d1,8) intravenously every three weeks for up to 6 cycles.Maintenance apatinib (500mg po qd) was administered until disease progression or unacceptable toxicity.

Apatinib+Irinotecan

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically-confirmed, high-grade glioma(WHO Ⅲ/Ⅳ) who have progressed on temozolomide, or radiotherapy alone, or combined with chemotherapy within 3 months after surgery .
  • With measurable or evaluable disease defined by RECIST 1.1 criteria by MRI scan.
  • Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
  • Life expectancy ≥3 months.
  • No evidence of serious cardiopulmonary function damage, postoperative complication and hemorrhage on the baseline.
  • No history of cerebral embolism, cerebral hemorrhage and serious hypertension disease.
  • Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents (except 6 weeks from nitrosoureas and mitomycin), radiotherapy and surgery.
  • Patients have adequate organ function as defined by the following criteria:
  • Hemoglobin (HGB) ≥90g/L
  • Absolute neutrophil count (ANC) ≥1.5×109/L
  • White blood cell (WBC) ≥3.0×109/L
  • Platelet count ≥80×109/L
  • Alanine aminotransferase(ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis
  • Creatinine (Cr) of ≤1.25 UNL or creatinine clearance(Ccr) \> 45 ml/min.
  • Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment.
  • +1 more criteria

You may not qualify if:

  • Pregnant or lactating women.
  • Inadequately controlled hypertension (defined as systolic blood pressure \> 140 and/or diastolic blood pressure \> 90 mmHg on antihypertensive medications).
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure.
  • Coronary heart disease greater than ClassⅠ;Ⅰ-level arrhythmia (including QT interval prolongation≥440 ms) together with ClassⅠcardiac dysfunction
  • Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
  • Abnormal Coagulation (international normalized ratio\>1.5, prothrombin time\>UNL+4s,activated partial thromboplastin time\>1.5 UNL), with tendency of bleeding.
  • Currently receive thrombolytic and anticoagulation therapy
  • History of pneumorrhagia(CTCAE grade ≥2 ) or other parts hemorrhage(CTCAE grade ≥3 ) within 4 weeks prior to treatment.
  • History of artery thrombosis and phlebothrombosis, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 6 month prior to treatment.
  • Medical history of clinically significant thrombosis (bleeding or clotting disorder), excluding warfarin(1mg po qd) and aspirin(80-100mg po qd) for prevention under INR≤1.5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First's People Hospital of Lianyungang

Lianyungang, Jiangsu, 222000, China

RECRUITING

Related Publications (1)

  • Wang L, Liang L, Yang T, Qiao Y, Xia Y, Liu L, Li C, Lu P, Jiang X. A pilot clinical study of apatinib plus irinotecan in patients with recurrent high-grade glioma: Clinical Trial/Experimental Study. Medicine (Baltimore). 2017 Dec;96(49):e9053. doi: 10.1097/MD.0000000000009053.

    PMID: 29245310DERIVED

MeSH Terms

Conditions

Glioma

Interventions

apatinibIrinotecan

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Central Study Contacts

Xiaodong Jiang, Doctor

CONTACT

+86018961326201jxdysy1970@163.com

Tao YANG, Master

CONTACT

+8601896132779218961327792@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

CN(1)