Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
OSI Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01154335
First received: June 29, 2010
Last updated: January 6, 2015
Last verified: January 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Drug: OSI-906
Drug: Everolimus

  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
No text entered.

Reporting Groups
  Description
Dose Level 1

combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Dose Level 2

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days

Dose Level 2a

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days


Participant Flow:   Overall Study
    Dose Level 1     Dose Level 2     Dose Level 2a  
STARTED     7     6     5  
COMPLETED     0 [1]   0 [1]   0 [1]
NOT COMPLETED     7     6     5  
[1] Patients continued treatment until disease progression or unacceptable toxicity occurred.



  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
Dose Level 1

combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Dose Level 2

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days

Dose Level 2a

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level 2     Dose Level 2a     Total  
Number of Participants  
[units: participants]
  7     6     5     18  
Age  
[units: years]
Median ( Full Range )
  55  
  ( 47 to 73 )  
  54  
  ( 51 to 76 )  
  70  
  ( 44 to 76 )  
  55  
  ( 44 to 76 )  
Gender  
[units: participants]
       
Female     4     4     1     9  
Male     3     2     4     9  
Region of Enrollment  
[units: participants]
       
United States     7     6     5     18  



  Outcome Measures
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1.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.   [ Time Frame: 18 Months ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: 18 Months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 18 months ]

4.  Secondary:   Response Rate   [ Time Frame: 18 months ]


  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: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01154335     History of Changes
Other Study ID Numbers: SCRI GI 124
Study First Received: June 29, 2010
Results First Received: January 6, 2015
Last Updated: January 6, 2015
Health Authority: United States: Food and Drug Administration