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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00866697




Registration number
NCT00866697
Ethics application status
Date submitted
19/03/2009
Date registered
20/03/2009

Titles & IDs
Public title
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Scientific title
A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Secondary ID [1] 0 0
2008-004672-50
Secondary ID [2] 0 0
110655
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib
Treatment: Drugs - Placebo

Placebo comparator: Placebo - matched placebo tablet administered orally once daily for up to 24 months

Experimental: Pazopanib - Pazopanib tablet administered orally at 800 mg once daily for up to 24 months


Treatment: Drugs: Pazopanib
Pazopanib 800 mg tablet daily for 104 weeks (24 months)

Treatment: Drugs: Placebo
Matching placebo 800 mg tablet daily, for 104 weeks (24 months).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-assessed Progression-free Survival (PFS)
Timepoint [1] 0 0
From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
Secondary outcome [1] 0 0
Overall Survival - Median
Timepoint [1] 0 0
From the date of randomization until the date of death due to any cause up to approximately 25 months
Secondary outcome [2] 0 0
Overall Survival: Number of Participants Experiencing Death
Timepoint [2] 0 0
From the date of randomization until the date of death due to any cause up to approximately 25 months
Secondary outcome [3] 0 0
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
Timepoint [3] 0 0
From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
Secondary outcome [4] 0 0
3-year Progression-free Survival
Timepoint [4] 0 0
Up to 3 years after randomization
Secondary outcome [5] 0 0
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [5] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [6] 0 0
Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [6] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [7] 0 0
Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [7] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [8] 0 0
Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [8] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [9] 0 0
Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [9] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [10] 0 0
Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [10] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [11] 0 0
Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [11] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [12] 0 0
Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [12] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [13] 0 0
Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [13] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [14] 0 0
Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25
Timepoint [14] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [15] 0 0
Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm
Timepoint [15] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [16] 0 0
Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade
Timepoint [16] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [17] 0 0
Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade
Timepoint [17] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [18] 0 0
Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)
Timepoint [18] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)

Eligibility
Key inclusion criteria
* written informed consent
* At least 18 years old.
* Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
* Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
* No evidence of disease progression
* ECOG status of 0 or 2
* Able to swallow and retain oral medication.
* Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

* Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
* Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
* Platelets at least 100 X 10^9/L
* Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
* Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
* Total bilirubin up to 1.5 X ULN
* AST and ALT up to 2.5 X ULN Renal
* Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

* Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis.
* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
* Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
* Clinically significant gastrointestinal abnormalities
* Prolongation of corrected QT interval (QTc) > 480 msecs
* History of any one or more cardiovascular conditions within the past 6 months prior to randomization
* Cardiac angioplasty or stenting
* Myocardial infarction
* Unstable angina
* Symptomatic peripheral vascular disease

* Class III or IV congestive heart failure
* Poorly controlled hypertension
* History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
* Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding diathesis.
* Hemoptysis within 6 weeks prior to randomization.
* Endobronchial metastases.
* Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Investigational or anti-VEGF anticancer therapy prior to study randomization.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
* Invasive malignancies that showed activity of disease within 5 years prior to randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2017
Sample size
Target
Accrual to date
Final
940
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [4] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [5] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [6] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [7] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [8] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [9] 0 0
Novartis Investigative Site - Malvern
Recruitment hospital [10] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [11] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [12] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [13] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
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Virginia
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Austria
State/province [7] 0 0
Graz
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Austria
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Innsbruck
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Austria
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Klagenfurt Am Woerthersee
Country [10] 0 0
Austria
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Korneuburg
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Austria
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Krems
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Austria
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Leoben
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Austria
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Linz
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Austria
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Oberpullendorf
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Austria
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Wien
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Belgium
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Bonheiden
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Belgium
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Duffel
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Belgium
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Gent
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Belgium
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Kortrijk
Country [20] 0 0
Belgium
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Leuven
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Belgium
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Libramont
Country [22] 0 0
Belgium
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Liege
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Belgium
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Namur
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Belgium
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Oostende
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Guangdong
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China
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Jiangsu
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China
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Liaoning
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China
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Shandong
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China
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Zhejiang
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China
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Beijing
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China
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Tianjin
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Aalborg
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Herlev
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Herning
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Lyon Cedex 08
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Metz Cedex 03
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Mont de Marsan
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Montpellier cedex 5
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Montpellier
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Mougins Cedex 2
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Nancy
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Nice Cedex 2
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Paris cedex 05
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Paris Cedex 4
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Bayern
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Thueringen
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Campania
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Lombardia
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Molise
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Piemonte
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Iwate
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Miyagi
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Osaka
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Saitama
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Tottori
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Goyang-si, Gyeonggi-do
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Kangnam-Ku ,Seoul
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Korea, Republic of
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Seoul
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromso
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Alcorcon (Madrid)
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Spain
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Barcelona
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Spain
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Cartagena (Murcia)
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Spain
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Elche
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Spain
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Lerida
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Spain
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Madrid
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Spain
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Murcia (El Palmar)
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Sabadell (Barcelona)
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Spain
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San Sebastian
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Spain
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Santiago de Compostela
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Spain
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Terrassa
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Linkoping
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Sweden
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Lund
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Sweden
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Stockholm
Country [151] 0 0
Sweden
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Uppsala
Country [152] 0 0
Taiwan
State/province [152] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/97/NCT00866697/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00866697