NCT01465243

Brief Summary

To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4 nonsmall-cell-lung-cancer

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

2.1 years

First QC Date

November 1, 2011

Last Update Submit

February 13, 2014

Conditions

Non-small Cell Lung Cancer

Keywords

EfficacySafetyEGFR-TKIphase IVNSCLCDose escalation

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    6-12 months

Secondary Outcomes (5)

  • Overall survival

    6 months -1 year

  • Objective response rate

    3-6 months

  • Time to progression

    3-6 months

  • Health-Related Quality of Life (HR QOL)

    1 year

  • Number of Participants with adverse events and serious adverse events (SAEs)

    1 year

Study Arms (1)

Icotinib

EXPERIMENTAL

This is a single arm study.

Drug: Icotinib

Interventions

IcotinibDRUG

125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)

Also known as: BPI-2009, Conmana
Icotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
  • Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment.
  • Measurable, evaluable disease outside of a radiation port.

You may not qualify if:

  • Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital of People's Liberation Army（PLA）

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Li Xi qing, M.D.

    307 Hospital of People's Liberation Army（PLA）

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2013

Study Completion

February 1, 2014

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations

CN(1)