Phase 2
N=16
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00345540 ↗Enrolled (actual)
16
Serious AEs
60.0%
Results posted
Mar 2015
Primary outcome: Primary: Response Rate — 0; 1; 8; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NOV-002 (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cellectar Biosciences, Inc.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
0; 1; 8; 6 | — |
| SECONDARY Safety of NOV-002 and Carboplatin |
0; 8; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
19.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00345540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.