Trial Outcomes & Findings for Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma (NCT NCT01506596)

NCT ID: NCT01506596

Last Updated: 2017-02-15

Results Overview

Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of \>=1 new lesion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Assessed after 12 weeks of study treatment

Results posted on

2017-02-15

Participant Flow

Participant milestones

Participant milestones
Measure
Pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Overall Study
STARTED
42
Overall Study
COMPLETED
41
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Overall Study
ineligible pathology
1

Baseline Characteristics

Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pazopanib
n=41 Participants
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Age, Continuous
62.0 years
STANDARD_DEVIATION 15.52 • n=5 Participants
Gender
Female
14 Participants
n=5 Participants
Gender
Male
27 Participants
n=5 Participants
Region of Enrollment
United States
41 participants
n=5 Participants

PRIMARY outcome

Timeframe: Assessed after 12 weeks of study treatment

Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of \>=1 new lesion.

Outcome measures

Outcome measures
Measure
Pazopanib
n=41 Participants
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
12-week Progression Free Rate
68.29 percentage of participants
Interval 51.91 to 81.92

SECONDARY outcome

Timeframe: Date of Consent until progression or death, up to 27 months

PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.

Outcome measures

Outcome measures
Measure
Pazopanib
n=41 Participants
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Progression Free Survival (PFS)
4.44 months
Interval 3.2 to 6.5

SECONDARY outcome

Timeframe: Date of consent until end of study treatment, up to 32 months

Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is \>=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is \>=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of \>=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure
Pazopanib
n=41 Participants
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Best Overall Response
Complete response
0 percentage of participants
Best Overall Response
Partial Response
2.4 percentage of participants
Best Overall Response
Stable Disease
41.5 percentage of participants
Best Overall Response
Progressive Disease
43.9 percentage of participants
Best Overall Response
Inevaluable
12.2 percentage of participants

SECONDARY outcome

Timeframe: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression

Population: Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed.

Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date of Consent until death, up to 32 months

OS was measured from date of consent until time of death from any cause, up to 32 months.

Outcome measures

Outcome measures
Measure
Pazopanib
n=41 Participants
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Overall Survival (OS)
12.62 months
Interval 8.5 to 16.2

Adverse Events

Pazopanib

Serious events: 17 serious events
Other events: 39 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Pazopanib
n=41 participants at risk
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders
Thrombocytopenia
2.4%
1/41
Gastrointestinal disorders
Abdominal Pain
2.4%
1/41
Gastrointestinal disorders
Gastric Perforation
4.9%
2/41
Gastrointestinal disorders
Large Intestine Perforation
2.4%
1/41
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
2.4%
1/41
Gastrointestinal disorders
Small Intestinal Obstruction
2.4%
1/41
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
2.4%
1/41
General disorders
death
4.9%
2/41
General disorders
Fatigue
2.4%
1/41
Hepatobiliary disorders
Hepatic Haemorrhage
2.4%
1/41
Infections and infestations
Cellulitis
2.4%
1/41
Infections and infestations
Escherichia Sepsis
2.4%
1/41
Infections and infestations
Perirectal Abscess
2.4%
1/41
Infections and infestations
Sepsis
2.4%
1/41
Investigations
International Normalised Ratio Increased
2.4%
1/41
Metabolism and nutrition disorders
Dehydration
2.4%
1/41
Nervous system disorders
Depressed Level Of Consciousness
2.4%
1/41
Nervous system disorders
Dizziness
2.4%
1/41
Nervous system disorders
Transient Ischaemic Attack
2.4%
1/41
Psychiatric disorders
Mental Disorder Due To A General Medical Condition
2.4%
1/41
Renal and urinary disorders
Acute Kidney Injury
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Aspiration
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.4%
1/41

Other adverse events

Other adverse events
Measure
Pazopanib
n=41 participants at risk
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders
Anaemia
17.1%
7/41
Blood and lymphatic system disorders
Leukopenia
2.4%
1/41
Blood and lymphatic system disorders
Neutropenia
2.4%
1/41
Blood and lymphatic system disorders
Thrombocytopenia
4.9%
2/41
Cardiac disorders
Atrial Fibrillation
2.4%
1/41
Cardiac disorders
Cardiac Failure Congestive
2.4%
1/41
Cardiac disorders
Palpitations
2.4%
1/41
Cardiac disorders
Sinus Tachycardia
2.4%
1/41
Ear and labyrinth disorders
Tinnitus
2.4%
1/41
Ear and labyrinth disorders
Vertigo
2.4%
1/41
Endocrine disorders
Hyperthyroidism
2.4%
1/41
Endocrine disorders
Hypothyroidism
19.5%
8/41
Eye disorders
Exfoliation Syndrome
2.4%
1/41
Eye disorders
Exophthalmos
2.4%
1/41
Eye disorders
Eye Swelling
2.4%
1/41
Eye disorders
Periorbital Oedema
2.4%
1/41
Eye disorders
Scleral Disorder
4.9%
2/41
Eye disorders
Vision Blurred
4.9%
2/41
Gastrointestinal disorders
Abdominal Distension
7.3%
3/41
Gastrointestinal disorders
Abdominal Pain
22.0%
9/41
Gastrointestinal disorders
Abdominal Pain Lower
4.9%
2/41
Gastrointestinal disorders
Abdominal Pain Upper
9.8%
4/41
Gastrointestinal disorders
Colonic Fistula
2.4%
1/41
Gastrointestinal disorders
Constipation
12.2%
5/41
Gastrointestinal disorders
Dental Caries
4.9%
2/41
Gastrointestinal disorders
Diarrhoea
34.1%
14/41
Gastrointestinal disorders
Dry Mouth
4.9%
2/41
Gastrointestinal disorders
Dysphagia
2.4%
1/41
Gastrointestinal disorders
Flatulence
4.9%
2/41
Gastrointestinal disorders
Gastrointestinal Fistula
2.4%
1/41
Gastrointestinal disorders
Gastrointestinal Motility Disorder
2.4%
1/41
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
4.9%
2/41
Gastrointestinal disorders
Haemorrhoids
2.4%
1/41
Gastrointestinal disorders
Ileus
2.4%
1/41
Gastrointestinal disorders
Impaired Gastric Emptying
2.4%
1/41
Gastrointestinal disorders
Large Intestinal Ulcer Haemorrhage
2.4%
1/41
Gastrointestinal disorders
Nausea
39.0%
16/41
Gastrointestinal disorders
Proctalgia
4.9%
2/41
Gastrointestinal disorders
Proctitis
2.4%
1/41
Gastrointestinal disorders
Rectal Haemorrhage
2.4%
1/41
Gastrointestinal disorders
Stomatitis
7.3%
3/41
Gastrointestinal disorders
Toothache
2.4%
1/41
Gastrointestinal disorders
Vomiting
19.5%
8/41
General disorders
Asthenia
2.4%
1/41
General disorders
Chest Pain
2.4%
1/41
General disorders
Early Satiety
2.4%
1/41
General disorders
Fatigue
29.3%
12/41
General disorders
Localised Oedema
2.4%
1/41
General disorders
Non-Cardiac Chest Pain
2.4%
1/41
General disorders
Oedema Peripheral
12.2%
5/41
General disorders
Pain
2.4%
1/41
General disorders
Peripheral Swelling
4.9%
2/41
General disorders
Pyrexia
2.4%
1/41
General disorders
Temperature Intolerance
2.4%
1/41
Infections and infestations
Diverticulitis
2.4%
1/41
Infections and infestations
Gastrointestinal Infection
2.4%
1/41
Infections and infestations
Herpes Zoster
2.4%
1/41
Infections and infestations
Nail Infection
2.4%
1/41
Infections and infestations
Pneumonia
2.4%
1/41
Infections and infestations
Septic Shock
2.4%
1/41
Infections and infestations
Skin Infection
4.9%
2/41
Infections and infestations
Upper Respiratory Tract Infection
2.4%
1/41
Infections and infestations
Urinary Tract Infection
9.8%
4/41
Injury, poisoning and procedural complications
Fall
4.9%
2/41
Injury, poisoning and procedural complications
Stress Fracture
2.4%
1/41
Injury, poisoning and procedural complications
Subdural Haematoma
2.4%
1/41
Injury, poisoning and procedural complications
Transfusion Reaction
2.4%
1/41
Investigations
Activated Partial Thromboplastin Time Prolonged
2.4%
1/41
Investigations
Alanine Aminotransferase Increased
7.3%
3/41
Investigations
Aspartate Aminotransferase Increased
4.9%
2/41
Investigations
Blood Bilirubin Increased
2.4%
1/41
Investigations
Blood Creatinine Increased
9.8%
4/41
Investigations
Blood Culture Positive
2.4%
1/41
Investigations
Blood Thyroid Stimulating Hormone Increased
4.9%
2/41
Investigations
Electrocardiogram QT Prolonged
2.4%
1/41
Investigations
Gastrointestinal Infection
2.4%
1/41
Investigations
International Normalised Ratio Increased
2.4%
1/41
Investigations
Lipase Increased
2.4%
1/41
Investigations
Neutrophil Count Decreased
4.9%
2/41
Investigations
Platelet Count Decreased
17.1%
7/41
Investigations
Prothrombin Time Prolonged
2.4%
1/41
Investigations
Troponin I Increased
2.4%
1/41
Investigations
Urine Output Decreased
2.4%
1/41
Investigations
Urine Protein/Creatinine Ratio
7.3%
3/41
Investigations
Weight Decreased
17.1%
7/41
Metabolism and nutrition disorders
Decreased Appetite
17.1%
7/41
Metabolism and nutrition disorders
Hyperkalaemia
4.9%
2/41
Metabolism and nutrition disorders
Hyperuricaemia
2.4%
1/41
Metabolism and nutrition disorders
Hypoalbuminaemia
12.2%
5/41
Metabolism and nutrition disorders
Hypoglycaemia
2.4%
1/41
Metabolism and nutrition disorders
Hypokalaemia
17.1%
7/41
Metabolism and nutrition disorders
Hypomagnesaemia
4.9%
2/41
Metabolism and nutrition disorders
Hyponatraemia
9.8%
4/41
Metabolism and nutrition disorders
Hypophosphataemia
9.8%
4/41
Metabolism and nutrition disorders
Iron Deficiency
2.4%
1/41
Metabolism and nutrition disorders
Metabolic Acidosis
4.9%
2/41
Musculoskeletal and connective tissue disorders
Arthralgia
4.9%
2/41
Musculoskeletal and connective tissue disorders
Back Pain
9.8%
4/41
Musculoskeletal and connective tissue disorders
Fistula
2.4%
1/41
Musculoskeletal and connective tissue disorders
Flank Pain
2.4%
1/41
Musculoskeletal and connective tissue disorders
Muscle Spasms
2.4%
1/41
Musculoskeletal and connective tissue disorders
Muscular Weakness
2.4%
1/41
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
4.9%
2/41
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
2.4%
1/41
Musculoskeletal and connective tissue disorders
Myalgia
4.9%
2/41
Musculoskeletal and connective tissue disorders
Pain In Extremity
9.8%
4/41
Musculoskeletal and connective tissue disorders
Pathological Fracture
2.4%
1/41
Musculoskeletal and connective tissue disorders
Tendonitis
2.4%
1/41
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Adenoma
2.4%
1/41
Nervous system disorders
Aphasia
2.4%
1/41
Nervous system disorders
Disturbance In Attention
2.4%
1/41
Nervous system disorders
Dizziness
17.1%
7/41
Nervous system disorders
Dysgeusia
14.6%
6/41
Nervous system disorders
Headache
4.9%
2/41
Nervous system disorders
Hypoaesthesia
2.4%
1/41
Nervous system disorders
Memory Impairment
2.4%
1/41
Nervous system disorders
Metabolic Encephalopathy
2.4%
1/41
Nervous system disorders
Neuralgia
2.4%
1/41
Nervous system disorders
Paraesthesia
2.4%
1/41
Nervous system disorders
Peripheral Sensory Neuropathy
2.4%
1/41
Nervous system disorders
Syncope
2.4%
1/41
Nervous system disorders
Vocal Cord Paralysis
2.4%
1/41
Psychiatric disorders
Agitation
2.4%
1/41
Psychiatric disorders
Anxiety
2.4%
1/41
Psychiatric disorders
Confusional State
2.4%
1/41
Psychiatric disorders
Depression
2.4%
1/41
Psychiatric disorders
Insomnia
7.3%
3/41
Psychiatric disorders
Restlessness
2.4%
1/41
Renal and urinary disorders
Pollakiuria
4.9%
2/41
Renal and urinary disorders
Proteinuria
2.4%
1/41
Renal and urinary disorders
Urinary Incontinence
2.4%
1/41
Reproductive system and breast disorders
Testicular Swelling
2.4%
1/41
Reproductive system and breast disorders
Vaginal Haemorrhage*f
7.1%
1/14
Reproductive system and breast disorders
Vulvovaginal Dryness*f
14.3%
2/14
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Cough
7.3%
3/41
Respiratory, thoracic and mediastinal disorders
Dysphonia
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Dyspnoea
7.3%
3/41
Respiratory, thoracic and mediastinal disorders
Epistaxis
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Hiccups
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
4.9%
2/41
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
2.4%
1/41
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
7.3%
3/41
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
2.4%
1/41
Skin and subcutaneous tissue disorders
Alopecia
2.4%
1/41
Skin and subcutaneous tissue disorders
Dermatitis
2.4%
1/41
Skin and subcutaneous tissue disorders
Dry Skin
4.9%
2/41
Skin and subcutaneous tissue disorders
Erythema
2.4%
1/41
Skin and subcutaneous tissue disorders
Erythema Multiforme
4.9%
2/41
Skin and subcutaneous tissue disorders
Granulomatous Dermatitis
2.4%
1/41
Skin and subcutaneous tissue disorders
Hair Colour Changes
7.3%
3/41
Skin and subcutaneous tissue disorders
Intertrigo
2.4%
1/41
Skin and subcutaneous tissue disorders
Nail Discolouration
2.4%
1/41
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
12.2%
5/41
Skin and subcutaneous tissue disorders
Pruritus
9.8%
4/41
Skin and subcutaneous tissue disorders
Rash
7.3%
3/41
Skin and subcutaneous tissue disorders
Rash Macular
2.4%
1/41
Skin and subcutaneous tissue disorders
Rash Papular
2.4%
1/41
Skin and subcutaneous tissue disorders
Skin Exfoliation
4.9%
2/41
Skin and subcutaneous tissue disorders
Skin Exfoliation*m
3.7%
1/27
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
7.3%
3/41
Skin and subcutaneous tissue disorders
Skin Mass
2.4%
1/41
Skin and subcutaneous tissue disorders
Skin Necrosis
2.4%
1/41
Skin and subcutaneous tissue disorders
Skin Ulcer
7.3%
3/41
Skin and subcutaneous tissue disorders
Stasis Dermatitis
2.4%
1/41
Skin and subcutaneous tissue disorders
Urticaria
2.4%
1/41
Vascular disorders
Deep Vein Thrombosis
4.9%
2/41
Vascular disorders
Hypertension
36.6%
15/41
Vascular disorders
Hypotension
7.3%
3/41

Additional Information

Dr. Mark Walker, VP of Scientific Affairs

Vector Oncology LLC

Phone: 901-435-5570

Results disclosure agreements

  • Principal investigator is a sponsor employee Institution/PI may use Institution/PI derived Study results in a Publication provided Publication does not disclose Vector Confidential Information unnecessary to publish Study results. Institution/PI will submit to Vector for review/comment proposed Publication and data necessary for meaningful review at least 30 days prior to submission. Vector may request delay of submission up to 60 days in order to file patent applications relating to an Invention.
  • Publication restrictions are in place

Restriction type: OTHER