NCT00345540

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cellectar Biosciences, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	NOV-002	60 mg / mL / day / 20-23 Days
DRUG	Carboplatin	AUC 5 following IV bolus administration of NOV-002

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-05-01
• Completion: 2008-06-01
• First posted: 2006-06-28
• Last updated: 2015-03-10
• Results posted: 2015-03-10

Locations

2 sites across 1 country: United States