Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004116

Trial Description

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Title

Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

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Trial Acronym

COMPARZ

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is being conducted to provide a direct comparison of the efficacy, safety and
tolerability for pazopanib and sunitinib (SUTENT)

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Brief Summary in Scientific Language

This study will evaluate the efficacy and safety of pazopanib compared to sunitinib in
subjects with advanced RCC who have received no prior systemic therapy for advanced or
metastatic RCC. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib
to be administered once daily orally continuous dosing or 50mg sunitinib to be administered
in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects
are permitted to receive supportive care throughout the study including transfusion of blood
and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents,
analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will
continue until subjects experience disease progression, unacceptable toxicity, withdraw
consent, or death.

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Organizational Data

  •   DRKS00004116
  •   2013/06/06
  •   2008/07/22
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00720941  (ClinicalTrials.gov)
  •   108844  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Carcinoma, Renal Cell
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: Pazopanib
  •   Drug: Sunitinib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Progression-free Survival (PFS); time frame: From randomization until the earliest date of disease progression or death (up to Study Week 191); PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.

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Secondary Outcome

- Overall Survival; time frame: From randomization until death (up to Study Week 268); Overall survival is defined as the time from randomization until death due to any cause.
- Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review; time frame: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167); The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.
- Time to Response; time frame: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167); Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.
- Duration of Response (DOR); time frame: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167); DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
- Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment); time frame: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268); See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline (predose); Weeks 4, 10, 16, and 22; The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value.
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
- Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.
- Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of "In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
- Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Baseline; Weeks 4, 10, 16, and 22; The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of "In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
- Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Weeks 4, 10, 16, and 22; The CTSQ assesses 3 domains related to the participant's satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.
- Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24; time frame: From Day 1 up to Week 24; Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.
- MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively); time frame: Weeks 4, 10, 16, and 22; The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Canada
  •   China
  •   Germany
  •   Ireland
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2008/08/31
  •   927
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Written informed consent

- Diagnosis of renal cell carcinoma with clear-cell component histology.

- Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy,
bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or
metastatic RCC

- Locally advanced or metastatic renal cell carcinoma

- Measurable disease by CT or MRI

- Karnofsky performance scale status of >=70

- Age >=18 years

- A female is eligible to enter and participate in this study if she is of:
non-childbearing or agrees to use adequate contraception.

- Adequate organ system function

- Total serum calcium concentration <12.0mg/dL

- Left ventricular ejection fraction >= lower limit of institutional normal.

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Exclusion Criteria

- Pregnant or lactating female (unless agrees to refrain from nursing throughout the
treatment period and for 14 days following the last dose of study)

- History of another malignancy (unless have been disease-free for 3 years)

- History or clinical evidence of central nervous system (CNS) metastases (unless have
previously-treated CNS metastases and meet all 3 of the following criteria are: are
asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to
enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)

- Clinically significant gastrointestinal abnormalities including, but not limited to:
malabsorption syndrome, major resection of the stomach or small bowel that could
affect the absorption of study drug, active peptic ulcer disease, known intraluminal
metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative
colitis, or other gastrointestinal conditions with increased risk of perforation,
history of abdominal fistula, gastrointestinal perforation, or intra abdominal
abscess within 28 days prior to beginning study treatment.

- Presence of uncontrolled infection.

- Prolongation of corrected QT interval (QTc) > 480 milliseconds

- History of any one or more of the following cardiovascular conditions within the past
12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina,
coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class
III or IV congestive heart failure, as defined by the New York Heart Association

- History of cerebrovascular accident including transient ischemic attack within the
past 12 months

- History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the
past 6 months (unless had recent DVT and have been treated with therapeutic
anti-coagulating agents for at least 6 weeks)

- Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or
diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive
medication(s) is permitted prior to study entry

- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer.

- Evidence of active bleeding or bleeding susceptibility

- Spitting/coughing up blood within 6 weeks of first dose of study drug

- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions
that could interfere with patient's safety, obtaining informed consent or compliance
to the study.

- Use any prohibited medications within 14 days of the first dose of study medication.

- Use of an investigational agent, including an investigational anti-cancer agent,
within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study
drug.

- Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
(eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg.
temsirolimus, everolimus, etc).

- Is now undergoing and/or has undergone in the 14 days immediately prior to first dose
of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy,
radiation therapy, immunotherapy, biological therapy, or hormonal therapy)

- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is
progressing in severity.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib or sunitinib.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GlaxoSmithKline
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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  • start of 1:1-Block address public-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.