Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00345540
First received: June 26, 2006
Last updated: February 25, 2015
Last verified: January 2009
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: NOV-002
Drug: Carboplatin

  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
The trials opened to enrollment July 2006 and the study was closed out June 2008. Recruitment locations were: Dana Farber Cancer/Partners Cancer Care, Boston, MA and Massachusetts General Hospital, Boston, MA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.

Reporting Groups
  Description
NOV-002 Plus Carboplatin NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.

Participant Flow:   Overall Study
    NOV-002 Plus Carboplatin  
STARTED     16 [1]
COMPLETED     15  
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 1 subject enrolled but not treated (off-trial for patient discretion)



  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
NOV-002 Plus Carboplatin NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.

Baseline Measures
    NOV-002 Plus Carboplatin  
Number of Participants  
[units: participants]
  15  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Gender  
[units: participants]
 
Female     15  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: At treatment completion (8 weeks) and monthly until disease progression ]

2.  Secondary:   Safety of NOV-002 and Carboplatin   [ Time Frame: Duration of trial and through 30-day follow-up period after final treatment ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From time of treatment start to time of disease progression ]


  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
The criterion for continuing to Stage II of the study (≥ 2 responses) was not met.


  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: Vice President, Clinical Development
Organization: Novelos Therapeutics, Inc.
phone: 617-244-1616
e-mail: hpalmin@novelos.com


No publications provided


Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00345540     History of Changes
Other Study ID Numbers: NOV002- IS21 -OC
Study First Received: June 26, 2006
Results First Received: July 9, 2013
Last Updated: February 25, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration