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A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OncoGenex Technologies
ClinicalTrials.gov Identifier:
NCT00138658
First received: August 26, 2005
Last updated: February 2, 2012
Last verified: February 2012
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: custirsen sodium

  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
Participants were recruited at 15 institutions with a primary focus on oncology and located in the United States and Canada. The date of the first screening visit was November 2004 and the last survival followup was February 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four subjects who were assigned a study ID number were determined to be ineligible (i.e., failed one or more inclusion/exclusion criteria) and were never treated.

Reporting Groups
  Description
OGX-011 - Intent to Treat Analysis Set Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.

Participant Flow:   Overall Study
    OGX-011 - Intent to Treat Analysis Set  
STARTED     81  
COMPLETED     20  
NOT COMPLETED     61  
Adverse Event                 23  
Death                 1  
Disease Progression                 21  
Physician Decision                 11  
Withdrawal by Subject                 5  



  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.
No text entered.

Reporting Groups
  Description
OGX-011 - Intent to Treat Analysis Set Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.

Baseline Measures
    OGX-011 - Intent to Treat Analysis Set  
Number of Participants  
[units: participants]
  81  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     56  
>=65 years     25  
Age  
[units: years]
Mean ( Full Range )
  60.4  
  ( 43 to 79 )  
Gender  
[units: participants]
 
Female     40  
Male     41  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     7  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     72  
More than one race     0  
Unknown or Not Reported     1  
Baseline ECOG [1]
[units: participants]
 
ECOG O     26  
ECOG 1     54  
ECOG 2     1  
Cancer Stage [2]
[units: participants]
 
Stage IIIB     15  
Stage IV     66  
[1]

The ECOG score is a performance status which attempts to quantify cancer patients' general well-being.

Grade 0=Fully active, able to carry on all pre-disease performance without restriction.

Grade 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

Grade 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.

[2]

Patients enrolled in this study were required to be either Stage IIIB or Stage IV.

Stage IIIB lung cancer is defined as a tumor of any size that has spread to distant lymph nodes, has invaded other structures in the chest (such as the heart or esophagus), or has a malignant pleural effusion (fluid build-up containing cancer cells between the layers lining the lungs).

Stage IV non-small cell lung cancer is defined as a tumor of any size that has spread (metastasized) to another region of the body or to another lobe of the lungs.




  Outcome Measures
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1.  Primary:   Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen   [ Time Frame: Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death. ]

3.  Secondary:   Overall Survival   [ Time Frame: All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death. ]

4.  Secondary:   Effect of OGX-011 on Serum Clusterin Levels   [ Time Frame: Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1 ]

5.  Secondary:   Cmax of OGX-011   [ Time Frame: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2. ]

6.  Secondary:   t1/2 of OGX-011   [ Time Frame: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2. ]

7.  Secondary:   AUC-0-last   [ Time Frame: Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2. ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Patricia Stewart, Vice President Medical Affairs
Organization: OncoGenex Pharmaceuticals
phone: 425-686-1500
e-mail: psstewartmd@oncogenex.com


Publications of Results:

Responsible Party: OncoGenex Technologies
ClinicalTrials.gov Identifier: NCT00138658     History of Changes
Other Study ID Numbers: OGX-011-05
Study First Received: August 26, 2005
Results First Received: October 6, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada