Trials / Completed
CompletedNCT01853644
Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 110 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the clinical activity of tivozanib in patients with platinum-resistant, recurrent ovarian, fallopian tube or primary peritoneal cancer. SECONDARY OBJECTIVES: I. Determining the potential survival advantage and characterizing the safety of single agent tivozanib in patients with platinum-resistant ovarian cancer. OUTLINE: Patients receive tivozanib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Conditions
- Recurrent Epithelial Ovarian Cancer
- Recurrent Fallopian Tube Cancer
- Recurrent Primary Peritoneal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tivozanib | 1.5 mg Given PO (orally)days 1-21 or every 28 day cycle |
Timeline
- Start date
- 2013-06-06
- Primary completion
- 2018-10-02
- Completion
- 2021-05-11
- First posted
- 2013-05-15
- Last updated
- 2021-10-12
- Results posted
- 2020-02-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01853644. Inclusion in this directory is not an endorsement.