Last updated: 11/07/2018 03:02:26
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Efficacy and Safety of Pazopanib Monotherapy after First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

GSK study ID
110655
See study documents
Clinicaltrials.gov ID
NCT00866697
EudraCT ID
2008-004672-50
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: This is a study to determine whether therapy with pazopanib is effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer has not progressed on first line chemotherapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Investigator-assessed Progression-free Survival (PFS)

Timeframe: 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 outcomes:

Number of participants with the indicated treatment-emergent thyroid-stimulating hormone (TSH) elevations above 5 million units per liter (MU/L)

Timeframe: 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)

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

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

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

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Number of participants with the indicated Grade 2, 3, and 4 on-therapy adverse events occurring in >=10% of participants in either treatment arm

Timeframe: 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)

3-year Progression-free Survival

Timeframe: Up to 3 years after randomization

Number of participants with the indicated on-therapy hematology grade shifts from Baseline grade

Timeframe: 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)

Change from Baseline in the EQ-5D (five dimensions) utility score at Week 13 and Months 7, 10, 13, 16, and 25

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

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

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Change from Baseline in QLQ-OV-28 module peripheral neuropathy (PN) symptoms score at Week 13 and Months 7, 10, 13, 16, and 25

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

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

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Change from Baseline in QLQ-OV-28 module sexuality functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Number of participants with any serious adverse event (SAE) and any adverse event

Timeframe: 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)

Number of participants with the indicated on-therapy chemistry grade shifts from Baseline grade

Timeframe: 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)

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

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Progression-free Survival per Gynecologic Cancer Intergroup (GCIG) Criteria

Timeframe: 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)

Change from Baseline in the EuroQOL EQ-5D (five dimensions) thermometer score at Week 13 and Months 7, 10, 13, 16, and 25

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Change from Baseline in QLQ-OV-28 module hormonal/menopausal symptoms score at Week 13 and Months 7, 10, 13, 16, and 25

Timeframe: Baseline; Week 13; Months 7, 10, 13, 16, and 25

Overall Survival

Timeframe: From the date of randomization until the date of death due to any cause (median time of follow-up was 24.3 months on pazopanib and 24.2 months on placebo)

Interventions:
  • Drug: Placebo
  • Drug: Pazopanib
    • Enrollment:
    940
    Primary completion date:
    2012-08-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimming R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, et al.Incorporation of Pazopanib in Maintenance Therapy of Ovarian Cancer.J Clin Oncol.2014;Oct 20 32(30):3374-82
    Medical condition
    Neoplasms, Ovarian
    Product
    pazopanib
    Collaborators
    GSK
    Study date(s)
    May 2009 to November 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • written informed consent
    • At least 18 years old.
    • 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.
    Inclusion and exclusion criteria
    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 1.
    • 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.
    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
    • 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2012-08-07
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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