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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT01449357
First received: September 29, 2011
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: zalutumumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Tyrosine
U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: zalutumumab Drug: zalutumumab
IV infusion, 16mg/kg on weekly basis until DP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449357

Sponsors and Collaborators
Genmab
Investigators
Study Chair: Not applicable, Study cancelled H. Lee Moffitt Cancer Center, Tampa, Florida, USA
  More Information

No publications provided

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT01449357     History of Changes
Other Study ID Numbers: GEN210
Study First Received: September 29, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genmab:
NSCLC
Zalutumumab
Efficacy
Safety

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013