Trial Outcomes & Findings for Tivozanib As Maintenance Therapy In GYN (NCT NCT01972516)

NCT ID: NCT01972516

Last Updated: 2017-06-05

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

2 Years

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Tivozanib 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.	Standard Care 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 Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tivozanib As Maintenance Therapy In GYN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=4 Participants Total of all reporting groups	Tivozanib n=3 Participants 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.	Standard Care n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=5 Participants	1 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Reporting the number of cycles each patient completed. Each cycle = 4 weeks.

Outcome measures

Outcome measures
Measure	Tivozanib n=3 Participants 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.	Standard Care n=1 Participants 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.
Progression-Free Survival (PFS) Comparison Patient 4	0 Cycles	2 Cycles
Progression-Free Survival (PFS) Comparison Patient 1	6 Cycles	0 Cycles
Progression-Free Survival (PFS) Comparison Patient 2	9 Cycles	0 Cycles
Progression-Free Survival (PFS) Comparison Patient 3	2 Cycles	0 Cycles

SECONDARY outcome

Timeframe: 2 Years

Population: Outcome measure not analyzed due to low accrual and subsequent termination of the study.

To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years

Population: Outcome measure not analyzed due to low accrual and subsequent termination of the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years

Population: Outcome measure not analyzed due to low accrual and subsequent termination of the study.

To compare rates of toxicity with and without maintenance therapy with Tivozanib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 Years

Population: Outcome measure not analyzed due to low accrual and subsequent termination of the study.

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.

Outcome measures

Outcome data not reported

Adverse Events

Tivozanib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Care

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tivozanib n=3 participants at risk 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.	Standard Care n=1 participants at risk 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.
Musculoskeletal and connective tissue disorders Athralgia	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.

Other adverse events

Additional Information

Susana Campos, MD

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Tivozanib n=3 participants at risk 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.	Standard Care n=1 participants at risk 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.
Renal and urinary disorders Urinary tract pain	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Athralgia	100.0% 3/3 • Number of events 8 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 3/3 • Number of events 3 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Mucositis oral	66.7% 2/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Infections and infestations Skin infection	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Skin and subcutaneous tissue disorders Rash maculopapular	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Reproductive system and breast disorders Pelvic pain	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Nervous system disorders Headache	66.7% 2/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Ear and labyrinth disorders Vertigo	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Dry mouth	66.7% 2/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
General disorders Fatigue	100.0% 3/3 • Number of events 3 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Ear and labyrinth disorders Tinnitus	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Cardiac disorders Chest pain - cardiac	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Reproductive system and breast disorders Vaginal pain	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Skin and subcutaneous tissue disorders Rash acneiform	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Renal and urinary disorders Urinary frequency	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Bloating	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 3 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Endocrine disorders Hypothyroidism	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 2 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	0.00% 0/1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from the time of first treatment to 30 days after the last treatment.