Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (TIVO)
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|ClinicalTrials.gov Identifier: NCT01853644|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2013
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Epithelial Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer||Drug: Tivozanib||Phase 2|
I. To determine the clinical activity of tivozanib in patients with platinum-resistant, recurrent ovarian, fallopian tube or primary peritoneal cancer.
I. Determining the potential survival advantage and characterizing the safety of single agent tivozanib in patients with platinum-resistant ovarian cancer.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Treatment (Tivozanib)
Tivozanib 1.5mg orally given daily for 3 weeks with one week off to complete a 4 week cycle until disease progression or adverse effects prohibit further therapy
1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
- Overall response rate to treatment with single agent tivozanib as measured by physical exam findings, serum CA-125 levels and/or measurement of index lesions via appropriate imaging studies using RECIST criteria [ Time Frame: Up to 5 years ]Response frequencies and percentages will be tabulated for all four groups and then an overall frequency of response (complete response [CR] or partial response [PR]) v. non-response (stable disease [SD] or progressive disease [PD]) will be calculated along with a one-sided lower limit 95% confidence interval, consistent with the approach used to specify staging of accrual.
- Duration of progression-free survival (PFS) [ Time Frame: Up to 5 years ]The Kaplan-Meier method will be utilized to estimate the median and overall distribution of PFS.
- Incidence of adverse events as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ]Grades will be summarized by counts and frequencies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853644
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|CDH-Delnor Health System - Northwestern Medicine Cancer Center|
|Warrenville, Illinois, United States, 60555|
|Principal Investigator:||Daniela Matei, MD||Northwestern University|