NCT01969955

Brief Summary

The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

October 22, 2013

Last Update Submit

April 24, 2014

Conditions

Squamous Cell Carcinoma of Lung

Keywords

nanoparticle albumin-bound paclitaxelSquamous Cell Carcinoma of Lung

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

    up to one year

Secondary Outcomes (4)

  • progression-free survival

    up to 15 months

  • Overall survival

    up to 2 years

  • Quality of life

    up to 15 months

  • Safety and tolerability

    up to 18 months

Other Outcomes (1)

  • secreted protein acidic and rich in cysteine (SPARC) expression level in tumor issues

    up to 15 months

Study Arms (1)

nanoparticle albumin-bound paclitaxel

EXPERIMENTAL

Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Drug: nanoparticle albumin-bound paclitaxel

Interventions

nanoparticle albumin-bound paclitaxelDRUG

Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Also known as: Abraxane, nab-paclitaxel
nanoparticle albumin-bound paclitaxel

Eligibility Criteria

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

You may qualify if:

  • Signed informed-consent form;
  • Age no less than 18 years;
  • Histologically confirmed locally advanced or metastatic squamous lung cancer;
  • Eastern Cooperative Oncology Group (ECOG) 0-2 with life expectation of no less than 12 weeks;
  • RECIST measurable lesions;
  • Disease progression after failure of platinum-based doublet therapy;
  • Adequate liver/renal/bone marrow function;
  • Human Chorionic Gonadotropin (HCG) test negative for female with contraception measures until 3 months after study end;
  • Compliance, and can be followed up regularly.

You may not qualify if:

  • Pregnant or breast-feeding female, or not willing to take contraception measures during study;
  • Radiotherapy within 30 days, systematic therapy within 21 days;
  • Serious infection requiring antibiotics intervention during recruitment;
  • Allergic to study drug;
  • Require concurrent biological target therapy;
  • More than grade 1 neuropathy;
  • Uncontrolled brain metastasis or mental illness;
  • Congestive heart failure, uncontrolled cardiac arrhythmia, etc;
  • Other malignancy within 5 years;
  • Can't be followed up or obey protocol;
  • Ineligible by the judge of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer institute and hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

TaxesAlbumin-Bound Paclitaxel130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Junling Li

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junling Li

CONTACT

86-13801178891drlijunling@vip.163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and chief physician

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

CN(1)