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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.
The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops responding to the chemotherapy (becomes resistant).
The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs. Specifically, it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone. NOV-002 has been used in other research studies on various types of cancer. It is approved for use in Russia. It is not approved by the US Food and Drug Administration (FDA) for use outside of research studies.
In this research study, the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOV-002 plus Carboplatin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOV-002 | Drug | 60 mg / mL / day / 20-23 Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | At treatment completion (8 weeks) and monthly until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of NOV-002 and Carboplatin | Duration of trial and through 30-day follow-up period after final treatment | |
| Progression Free Survival (PFS) | From time of treatment start to time of disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Kransner, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer/Partners Cancer Care | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | Posted | Number | Participants | At treatment completion (8 weeks) and monthly until disease progression |
|
|
Duration of trial (up to 8 weeks) and through 30-day follow-up period after final treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
The criterion for continuing to Stage II of the study (≥ 2 responses) was not met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Development | Novelos Therapeutics, Inc. | 617-244-1616 | hpalmin@novelos.com |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C529375 | NOV 002 |
| D019803 | Glutathione Disulfide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D005978 | Glutathione |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Carboplatin | Drug | AUC 5 following IV bolus administration of NOV-002 |
|
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Safety of NOV-002 and Carboplatin | Posted | Number | Adverse Events | Duration of trial and through 30-day follow-up period after final treatment |
|
|
|
| Secondary | Progression Free Survival (PFS) | Posted | Mean | Full Range | Weeks | From time of treatment start to time of disease progression |
|
|
|
| 9 |
| 15 |
| 15 |
| 15 |
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| DVT | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Bowel Obstruction | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Platinum Allergy | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
|