NCT00352950

Brief Summary

To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Status
withdrawn

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

First QC Date

April 6, 2006

Last Update Submit

September 4, 2018

Conditions

OncologyNon-Small Cell Lung Cancer

Keywords

NSCLC, Lung cancerPanitumumabSirolimusmTORMonoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • safety within the first 3 weeks

Secondary Outcomes (1)

  • pharmacodynamic analysis of mTOR

Interventions

AMG 954/PanitumumabDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer
  • Received only one prior treatment (not including radiation)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines
  • Life expectancy of ≥ 4 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function

You may not qualify if:

  • Brain metastases requiring treatment
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
  • Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment
  • Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors
  • Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment
  • Prior therapy with sirolimus, sirolimus analogs
  • Immunosuppressive agents within 28 days before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2006

First Posted

July 17, 2006

Study Start

March 1, 2006

Study Completion

February 1, 2008

Last Updated

September 6, 2018

Record last verified: 2018-09