Back to resultsZalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
zalutumumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Zalutumumab, Efficacy, Safety
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
zalutumumab
Arm Description
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01449357
Brief Title
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Trial never initiated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, Zalutumumab, Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zalutumumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zalutumumab
Intervention Description
IV infusion, 16mg/kg on weekly basis until DP
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Not applicable, Study cancelled
Organizational Affiliation
H. Lee Moffitt Cancer Center, Tampa, Florida, USA
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors
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