Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

NCT00387764 | Completed Phase 3 Results

• 1 other identifier: VEG107769
• Study Type: interventional
• Target: 80
• Locations: 19 countries
• Sites: 55

Brief Summary

This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.

Conditions

Carcinoma, Renal Cell

Keywords

renal cell carcinoma; pazopanib; anti-angiogenic therapy; open label

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

  An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.

  From Baseline to Follow-up (up to 6.230 years)

• Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)

  An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.

  From Baseline to Follow-up (up to 6.230 years)

• Number of Participants With Adverse Events Related to Investigational Product

  An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.

  From Baseline to Follow-up (up to 6.230 years)

• Median Time on Investigational Product

  The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.

  From Baseline to investigational product discontinuation (up to 6.230 years)

• Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline

  Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.

  From Baseline to investigational product discontinuation (up to 6.230 years)

• Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline

  Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC \[leukopenia\]), and prothrombin time international normalized ratio (PT \[INR\]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.

  From Baseline to investigational product discontinuation (up to 6.230 years)

• Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline

  Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury \[mmHg\]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (\<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, \>=170 mmHg) was assessed.

  From Baseline to investigational product discontinuation (up to 6.230 years)

• Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline

  Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of \<44 bpm, 44 to 100 bpm, 101 to 120 bpm, and \>120 bpm was assessed.

  From Baseline to investigational product discontinuation (up to 6.230 years)

• Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value

  The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett's formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett's QTc value) were summarized using the following reference ranges: \<450, 450 to 479, 480 to 499, 500 to 549, and \>550 milliseconds.

  From Baseline to investigational product discontinuation (up to 6.230 years)

Secondary Outcomes (6)

• Number of Participants With a Complete Response (CR) or Partial Response (PR)

  From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)

• Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)

  From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)

• Number of Participants With the Indicated Best Overall Response

  From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)

• Progression-free Survival (PFS)

  From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)

• Overall Survival (OS)

  From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)

Study Arms (1)

pazopanib arm

EXPERIMENTAL

This was a single arm study, therefore no control arm.

Drug: pazopanib

Interventions

pazopanib DRUG

800 mg daily dosing continously until progression

pazopanib arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Progressed from VEG105192 study treatment
• Patient's VEG105192 was placebo
• Baseline has good organ function

You may not qualify if:

• No brain metastasis

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (58)

GSK Investigational Site

Capital Federal, Buenos Aires, C1405CUB, Argentina

Location

GSK Investigational Site

Córdoba, Córdoba Province, 5000, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, S2000KZE, Argentina

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GSK Investigational Site

Quilmes, 1878, Argentina

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GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

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GSK Investigational Site

Waratah, New South Wales, 2298, Australia

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GSK Investigational Site

Hobart, Tasmania, 7000, Australia

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GSK Investigational Site

Heidelberg, Victoria, 3084, Australia

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GSK Investigational Site

Salzburg, A-5020, Austria

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GSK Investigational Site

Vienna, A-1100, Austria

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GSK Investigational Site

Belo Horizonte, Minas Gerais, 30150-270, Brazil

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GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

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GSK Investigational Site

Viña del Mar, Región de Valparaíso, 254-0364, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7500921, Chile

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GSK Investigational Site

Beijing, 100034, China

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GSK Investigational Site

Beijing, 100853, China

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GSK Investigational Site

Brno, 656 53, Czechia

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GSK Investigational Site

Chomutov, 430 12, Czechia

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GSK Investigational Site

Prague, 12808, Czechia

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GSK Investigational Site

Tartu, 51003, Estonia

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GSK Investigational Site

Rome, Lazio, 00133, Italy

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GSK Investigational Site

Rome, Lazio, 00152, Italy

Location

GSK Investigational Site

Riga, LV 1002, Latvia

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GSK Investigational Site

Kaunas, LT-50009, Lithuania

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GSK Investigational Site

Vilnius, LT-08660, Lithuania

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GSK Investigational Site

Christchurch, 8001, New Zealand

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GSK Investigational Site

Wellington, 6021, New Zealand

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GSK Investigational Site

Karachi, 74800, Pakistan

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GSK Investigational Site

Lahore, 54600, Pakistan

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GSK Investigational Site

Gdansk, 80-210, Poland

Location

GSK Investigational Site

Krakow, 31-108, Poland

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GSK Investigational Site

Krakow, 31-115, Poland

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GSK Investigational Site

Olsztyn, 10-226, Poland

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GSK Investigational Site

Olsztyn, 10-228, Poland

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GSK Investigational Site

Chelyabinsk, 454087, Russia

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GSK Investigational Site

Kazan', 420029, Russia

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GSK Investigational Site

Moscow, 115 478, Russia

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GSK Investigational Site

Moscow, 117 837, Russia

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GSK Investigational Site

Moscow, 129 128, Russia

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GSK Investigational Site

Omsk, 644013, Russia

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GSK Investigational Site

Saint Petersburg, 198255, Russia

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GSK Investigational Site

Samara, 443066, Russia

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GSK Investigational Site

Voronezh, 394062, Russia

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GSK Investigational Site

Yaroslavl, 150054, Russia

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GSK Investigational Site

Bratislava, 833 10, Slovakia

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GSK Investigational Site

Seoul, 110-744, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Songpa-gu, Seoul, 138-736, South Korea

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GSK Investigational Site

Sfax, 3000, Tunisia

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GSK Investigational Site

Sousse, 4054, Tunisia

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GSK Investigational Site

Tunis, 1007, Tunisia

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GSK Investigational Site

Tunis, 1008, Tunisia

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GSK Investigational Site

Donetsk, 83092, Ukraine

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GSK Investigational Site

Kharkiv, 61037, Ukraine

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GSK Investigational Site

Kyiv, 03115, Ukraine

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GSK Investigational Site

Bebington, Wirral, CH63 4JY, United Kingdom

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GSK Investigational Site

Belfast, Northern Ireland, BT9 7AB, United Kingdom

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GSK Investigational Site

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2012
• Last Updated: January 14, 2014
• Results First Posted: December 3, 2013

Record last verified: 2013-10

Locations

CZ (3); ES (1); SL (1); LI (2); PA (2); GB (3); PL (5); AU (2); CL (2); IT (2); RU (10); TU (4); UA (3); CN (2); KR (3); BR (2); LA (1); AR (5); NZ (2)