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GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L) (GRABM-L)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01497665
First received: December 20, 2011
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: May 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
Intervention: Drug: GRN1005

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GRN1005 Alone

GRN1005 alone

GRN1005: 650 mg/m2 IV every 3 weeks


Participant Flow:   Overall Study
    GRN1005 Alone
STARTED   16 
Completed Effifcacy Assessment   10 [1] 
COMPLETED   16 
NOT COMPLETED   0 
[1] Number of patients who completed efficacy assessment with CNS lesions per Overall RECIST 1.1.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
  1. Safety population (all patients): 16
  2. Efficacy population (defined as the number of patients who had ≥1 intracranial lesions followed as target or non-target lesions, and who were evaluated by Overall RECIST v.1.1):10

Reporting Groups
  Description
GRN1005 Alone

GRN1005 alone

GRN1005: 650 mg/m2 IV every 3 weeks


Baseline Measures
   GRN1005 Alone 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.2  (5.91) 
Gender 
[Units: Participants]
 
Female   10 
Male   6 
Region of Enrollment 
[Units: Participants]
 
Canada   0 
United States   16 


  Outcome Measures
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1.  Primary:   Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis   [ Time Frame: upon enrollment through end of study period (1 year after last patient is enrolled) ]

2.  Secondary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

3.  Secondary:   Duration of Overall Objective Response   [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

4.  Secondary:   Duration of Overall Progression Free Survival   [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]

5.  Secondary:   Six Month Overall Survival   [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Betty Lawrence, Vice President, Development
Organization: Angiochem Inc.
phone: 514-788-7800 ext 205
e-mail: blawrence@angiochem.com



Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT01497665     History of Changes
Other Study ID Numbers: CP1005B017
Study First Received: December 20, 2011
Results First Received: May 12, 2015
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration