Clinical trial · Interventional
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin
NCT00345540CI-TRIAL-00017095completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| NOV-002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NOV-002 plus Carboplatin
- 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.
- interventionNames
- Drug: NOV-002
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- At treatment completion (8 weeks) and monthly until disease progression
Secondary outcomes (2)
- measure
- Safety of NOV-002 and Carboplatin
- timeFrame
- Duration of trial and through 30-day follow-up period after final treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer * ECOG 0-1 * Platinum resistant or refractory disease defined as progressive disease within 6 months of completing or while receiving their last platinum containing regimen * Measurable disease Exclusion Criteria: * History of other malignancies within 2 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I endometrial cancer, basal or squamous cell skin cancer * Major surgery within 2 weeks of study entry * History of anaphylactic shock with prior platinum chemotherapy * Known history of central nervous system (CNS) metastases unless subject has had treatment with surgery or radiation therapy and is neurologically stable * Treatment with more than 3 lines of chemotherapy * Chronic use of systemic corticosteroids
References
Publications (0)
Data not yet available
No reference posted for this study.