NCT02980809

Brief Summary

The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

November 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 24, 2016

Last Update Submit

December 1, 2016

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    1 year

Secondary Outcomes (2)

  • Response rate

    1 year

  • Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0

    1 year

Study Arms (2)

Apatinib and topotecan

EXPERIMENTAL

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.

Drug: ApatinibDrug: Topotecan

Topotecan

PLACEBO COMPARATOR

Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.

Drug: Topotecan

Interventions

ApatinibDRUG
Apatinib and topotecan
TopotecanDRUG
Apatinib and topotecanTopotecan

Eligibility Criteria

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

You may qualify if:

  • limited or extensive-stage SCLC who had failed to first-line therapy
  • ≥18 years old
  • Eastern Cooperative Oncology Group performance status ≤2
  • at least one measurable lesion as defined by RECIST (version 1.1)
  • at least one measurable lung tumor lesion
  • WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL
  • AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases.

You may not qualify if:

  • symptomatic CNS metastases
  • concomitant or previous malignancies within the last 5 years
  • severe comorbidities; prior topotecan therapy
  • hypersensitivity or other contraindication to the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. doi: 10.1200/JCO.2006.06.5821.

    PMID: 17135646BACKGROUND

  • Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.

    PMID: 17513814BACKGROUND

  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

    PMID: 26884585BACKGROUND

  • Fruh M, De Ruysscher D, Popat S, Crino L, Peters S, Felip E; ESMO Guidelines Working Group. Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi99-105. doi: 10.1093/annonc/mdt178. Epub 2013 Jun 27. No abstract available.

    PMID: 23813929BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinibTopotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Central Study Contacts

Min-hang Zhou

CONTACT

86-10-66848733zhou_minhang@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 2, 2016

Study Start

March 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

December 2, 2016

Record last verified: 2016-11