Trial Outcomes & Findings for Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer (NCT NCT00345540)
NCT ID: NCT00345540
Last Updated: 2015-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At treatment completion (8 weeks) and monthly until disease progression
Results posted on
2015-03-10
Participant Flow
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
Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
NOV-002 Plus Carboplatin
n=15 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At treatment completion (8 weeks) and monthly until disease progressionOutcome measures
| Measure |
NOV-002 Plus Carboplatin
n=15 Participants
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.
|
|---|---|
|
Response Rate
Complete Response (CR)
|
0 Participants
|
|
Response Rate
Partial Response (PR)
|
1 Participants
|
|
Response Rate
Stable Disease (SD)
|
8 Participants
|
|
Response Rate
Progressive Disease (PD)
|
6 Participants
|
SECONDARY outcome
Timeframe: Duration of trial and through 30-day follow-up period after final treatmentOutcome measures
| Measure |
NOV-002 Plus Carboplatin
n=15 Participants
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.
|
|---|---|
|
Safety of NOV-002 and Carboplatin
CTC Grade 4 Adverse Events
|
0 Adverse Events
|
|
Safety of NOV-002 and Carboplatin
CTC Grade 3 Adverse Events
|
8 Adverse Events
|
|
Safety of NOV-002 and Carboplatin
CTC Grade 3 Related Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: From time of treatment start to time of disease progressionOutcome measures
| Measure |
NOV-002 Plus Carboplatin
n=15 Participants
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.
|
|---|---|
|
Progression Free Survival (PFS)
|
19.4 Weeks
Interval 4.0 to 38.0
|
Adverse Events
NOV-002 Plus Carboplatin
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NOV-002 Plus Carboplatin
n=15 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
General disorders
Fatigue
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Vascular disorders
DVT
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Bowel Obstruction
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Immune system disorders
Platinum Allergy
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Nervous system disorders
Neuropathy
|
6.7%
1/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
Other adverse events
| Measure |
NOV-002 Plus Carboplatin
n=15 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Abdominal Distension
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
9/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
General disorders
Fatigue
|
60.0%
9/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
General disorders
Oedema peripheral
|
20.0%
3/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Immune system disorders
Hypersensitivity
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Investigations
Haemoglobin decreased
|
40.0%
6/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Investigations
Platelet count decreased
|
26.7%
4/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Investigations
White blood cell count decreased
|
33.3%
5/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
26.7%
4/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Nervous system disorders
Nervous system disorders
|
26.7%
4/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
20.0%
3/15 • Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
|
Additional Information
Vice President, Clinical Development
Novelos Therapeutics, Inc.
Phone: 617-244-1616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place