Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00345540
Recruitment Status : Completed
First Posted : June 28, 2006
Results First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: NOV-002
Drug: Carboplatin
Enrollment 15
Recruitment Details 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 Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16 [1]
Completed 15
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
1 subject enrolled but not treated (off-trial for patient discretion)
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Response Rate
Hide Description [Not Specified]
Time Frame At treatment completion (8 weeks) and monthly until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 0
Partial Response (PR) 1
Stable Disease (SD) 8
Progressive Disease (PD) 6
2.Secondary Outcome
Title Safety of NOV-002 and Carboplatin
Hide Description [Not Specified]
Time Frame Duration of trial and through 30-day follow-up period after final treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Adverse Events
CTC Grade 4 Adverse Events 0
CTC Grade 3 Adverse Events 8
CTC Grade 3 Related Adverse Events 0
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description [Not Specified]
Time Frame From time of treatment start to time of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: Weeks
19.4
(4 to 38)
Time Frame Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NOV-002 Plus Carboplatin
Hide Arm/Group Description 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.
All-Cause Mortality
NOV-002 Plus Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NOV-002 Plus Carboplatin
Affected / at Risk (%)
Total   9/15 (60.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/15 (6.67%) 
Bowel Obstruction * 1  1/15 (6.67%) 
General disorders   
Fatigue * 1  1/15 (6.67%) 
Immune system disorders   
Platinum Allergy * 1  2/15 (13.33%) 
Nervous system disorders   
Syncope * 1  1/15 (6.67%) 
Neuropathy * 1  1/15 (6.67%) 
Psychiatric disorders   
Depression * 1  1/15 (6.67%) 
Vascular disorders   
DVT * 1  1/15 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NOV-002 Plus Carboplatin
Affected / at Risk (%)
Total   15/15 (100.00%) 
Blood and lymphatic system disorders   
Lymphopenia * 1  2/15 (13.33%) 
Gastrointestinal disorders   
Abdominal Distension * 1  2/15 (13.33%) 
Abdominal pain * 1  9/15 (60.00%) 
Constipation * 1  3/15 (20.00%) 
Diarrhoea * 1  2/15 (13.33%) 
Nausea * 1  7/15 (46.67%) 
Vomiting * 1  5/15 (33.33%) 
General disorders   
Fatigue * 1  9/15 (60.00%) 
Oedema peripheral * 1  3/15 (20.00%) 
Immune system disorders   
Hypersensitivity * 1  2/15 (13.33%) 
Investigations   
Haemoglobin decreased * 1  6/15 (40.00%) 
Platelet count decreased * 1  4/15 (26.67%) 
White blood cell count decreased * 1  5/15 (33.33%) 
Metabolism and nutrition disorders   
Anorexia * 1  2/15 (13.33%) 
Hyperglycaemia * 1  2/15 (13.33%) 
Hypoalbuminaemia * 1  2/15 (13.33%) 
Hypokalaemia * 1  2/15 (13.33%) 
Hypomagnesaemia * 1  4/15 (26.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/15 (13.33%) 
Nervous system disorders   
Nervous system disorders * 1  4/15 (26.67%) 
Psychiatric disorders   
Anxiety * 1  3/15 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/15 (13.33%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders * 1  3/15 (20.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
The criterion for continuing to Stage II of the study (≥ 2 responses) was not met.
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
Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00345540     History of Changes
Other Study ID Numbers: NOV002- IS21 -OC
First Submitted: June 26, 2006
First Posted: June 28, 2006
Results First Submitted: July 9, 2013
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015