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Tivozanib As Maintenance Therapy In GYN

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ClinicalTrials.gov Identifier: NCT01972516
Recruitment Status : Terminated (due to slow accrual)
First Posted : October 30, 2013
Results First Posted : August 24, 2016
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
National Comprehensive Cancer Network
AVEO Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Intervention Drug: Tivozanib
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities. Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Period Title: Overall Study
Started 3 1
Completed 3 1
Not Completed 0 0
Arm/Group Title Tivozanib Standard Care Total
Hide Arm/Group Description Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities. Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities. Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
1
 100.0%
3
  75.0%
>=65 years
1
  33.3%
0
   0.0%
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
3
 100.0%
1
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS) Comparison
Hide Description

To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)

Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Reporting the number of cycles each patient completed. Each cycle = 4 weeks.
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description:
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: Cycles
Patient 1 6 0
Patient 2 9 0
Patient 3 2 0
Patient 4 0 2
2.Secondary Outcome
Title Progression-Free Survival (PFS) Evaluation
Hide Description To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not analyzed due to low accrual and subsequent termination of the study.
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description:
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS) Evaluation
Hide Description To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not analyzed due to low accrual and subsequent termination of the study.
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description:
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity Rate Comparison
Hide Description To compare rates of toxicity with and without maintenance therapy with Tivozanib.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not analyzed due to low accrual and subsequent termination of the study.
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description:
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quality of Life (QOL) Evaluation
Hide Description To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measure not analyzed due to low accrual and subsequent termination of the study.
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description:
Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tivozanib Standard Care
Hide Arm/Group Description Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities. Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
All-Cause Mortality
Tivozanib Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tivozanib Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/1 (100.00%)    
Musculoskeletal and connective tissue disorders     
Athralgia * 1  1/3 (33.33%)  1 1/1 (100.00%)  1
Vascular disorders     
Hypertension * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tivozanib Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/1 (100.00%)    
Cardiac disorders     
Chest pain - cardiac * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Ear and labyrinth disorders     
Ear pain * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Vertigo * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Tinnitus * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Endocrine disorders     
Hypothyroidism * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  2/3 (66.67%)  2 0/1 (0.00%)  0
Mucositis oral * 1  2/3 (66.67%)  2 0/1 (0.00%)  0
Nausea * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Dry mouth * 1  2/3 (66.67%)  2 0/1 (0.00%)  0
Gastroesophageal reflux disease * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Bloating * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Dyspepsia * 1  1/3 (33.33%)  2 0/1 (0.00%)  0
Diarrhea * 1  1/3 (33.33%)  3 0/1 (0.00%)  0
General disorders     
Edema limbs * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Fatigue * 1  3/3 (100.00%)  3 1/1 (100.00%)  1
Non-cardiac chest pain * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Infections and infestations     
Skin infection * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Urinary tract infection * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalemia * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Hyperglycemia * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Hypomagnesemia * 1  2/3 (66.67%)  2 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Athralgia * 1  3/3 (100.00%)  8 0/1 (0.00%)  0
Myalgia * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Pain in extremity * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Generalized muscle weakness * 1  0/3 (0.00%)  0 1/1 (100.00%)  1
Nervous system disorders     
Headache * 1  2/3 (66.67%)  2 0/1 (0.00%)  0
Peripheral sensory neuropathy * 1  1/3 (33.33%)  2 0/1 (0.00%)  0
Dysgeusia * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Memory impairment * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Dizziness * 1  1/3 (33.33%)  2 0/1 (0.00%)  0
Psychiatric disorders     
Anxiety * 1  1/3 (33.33%)  1 1/1 (100.00%)  1
Renal and urinary disorders     
Urinary tract pain * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Urinary frequency * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Reproductive system and breast disorders     
Pelvic pain * 1  1/3 (33.33%)  1 1/1 (100.00%)  1
Vaginal pain * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  3/3 (100.00%)  3 0/1 (0.00%)  0
Pulmonary hypertension * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Cough * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculopapular * 1  1/3 (33.33%)  1 1/1 (100.00%)  1
Rash acneiform * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Vascular disorders     
Hypertension * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
Hot flashes * 1  1/3 (33.33%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susana Campos, MD
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5269
EMail: susana_campos@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01972516     History of Changes
Other Study ID Numbers: 13-375
First Submitted: October 24, 2013
First Posted: October 30, 2013
Results First Submitted: June 13, 2016
Results First Posted: August 24, 2016
Last Update Posted: June 5, 2017