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Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

This study has been withdrawn prior to enrollment.
(Trial never initiated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449357
First Posted: October 10, 2011
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genmab
September 29, 2011
October 10, 2011
October 10, 2011
Not Provided
Not Provided
Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months. [ Time Frame: within 6 months ]
Same as current
No Changes Posted
Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months. [ Time Frame: within 6 months ]
Same as current
Not Provided
Not Provided
 
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors
A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Drug: zalutumumab
IV infusion, 16mg/kg on weekly basis until DP
Experimental: zalutumumab
Intervention: Drug: zalutumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

  • Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

Exclusion Criteria:

  • Estimated life expectancy of less than 3 months.
  • Received the following treatments within 2 weeks prior to Visit 2:

    • Cytotoxic or cytostatic anti-cancer chemotherapy
    • Total resection or irradiation of the target lesion
    • Any investigational agent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01449357
GEN210
No
Not Provided
Not Provided
Genmab
Genmab
Not Provided
Study Chair: Not applicable, Study cancelled H. Lee Moffitt Cancer Center, Tampa, Florida, USA
Genmab
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP