Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (TIVO)
|ClinicalTrials.gov Identifier: NCT01853644|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2013
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
|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 :||31 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|
|Actual Study Start Date :||June 6, 2013|
|Actual Primary Completion Date :||October 2, 2018|
|Estimated Study Completion Date :||October 2023|
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 (ORR) [ Time Frame: Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days) ]
ORR is defined as the percentage of patients with complete response plus those with partial response as measured by RECIST 1.1 where:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Progression Free Survival (PFS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib [ Time Frame: Range of months 1-25 ]The Kaplan-Meier method will be utilized to estimate the median and overall distribution of PFS and will be defined from the start of treatment until the first documentation of progressive disease or death, whichever occurs first..
- Number of Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib [ Time Frame: During treatment and up to 30 days after completion of study treatment. Range of cycles 1-31 (1 cycle =28 days). ]Adverse events will be assessed by NCI CTCAE v 4.03. Adverse event that were determined to be serious adverse events (either grade 3, 4, or 5) related to study drug were collected. Grading is as follows:
- Overall Survival (OS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib [ Time Frame: Range of months 1-39 ]OS is defined from the start of treatment until date of death from any cause or date of last contact.
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|