AzTrials
AzTrials

Carcinoma, Renal CellPhase 2NCT00117637

BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) and Interferon in people with Carcinoma, Renal Cell, run by Bayer at 42 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to: Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Sorafenib (Nexavar, BAY43-9006) and Interferon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
42 sitesin 7 countries
Study dates
Jun 2005to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
  • Male or female patients >= 18 years of age
  • Patients who have a life expectancy of at least 12 weeks
  • Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (Renal Cell Carcinoma) histologically or cytologically documented
  • Patients must have undergone prior (at the time of primary diagnosis) complete surgical excision of primary RCC tumor
  • Patients must have had no prior systemic therapy for advanced RCC. Prior systemic therapy is defined as any treatment with a chemotherapy agent (or regimen), an immunotherapy agent (or regimen) or an investigational treatment agent (or regimen) against the renal cell carcinoma. Megestrol acetate or medroxyprogesterone will constitute as a prior systemic therapy
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  • Patients who have at least one uni-dimensional measurable lesion by CT (Computed tomography)-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, liver , and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
  • Hemoglobin >9.0 g/l
  • Absolute neutrophil count ( ANC)>1,500/mm3
  • Platelets> or = 100,000/ul
  • Total bilirubin < 1.5 x the upper limit of normal
  • ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • Amylase and lipase < 1.5 x the upper limit of normal
  • Serum creatinine < 2.0 x the upper limit of normal
  • PT (Prothrombin Time) or INR (International Normalized Ratio) and PTT (Partial Thromboplastin Time) < 1.5 x upper limit of normal (patients who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care)

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]\&T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated > 5 years prior to study entry
  • Complete renal shut-down requiring hemo- or peritoneal dialysis
  • History of cardiac disease : congestive heart failure > NYHA (New York Heart Association) class 2: active cardiovascular disease( MI (Distant metastasis) more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
  • Active clinically serious bacterial or fungal infections (>= grade 2 NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), Version 3)
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to this brain tumour site at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies (head CT or MRI at screening always required)
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  • Patients with seizure disorder requiring medication (such as steroid anti-epileptics)
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial

Trial locations and contacts

42 sites in 7 countries.

42 sites in 7 countries

United States9 sites

  • Study site

    Aurora, Colorado, 80010

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cleveland, Ohio, 44195-0002

  • Study site

    Dallas, Texas, 75246

  • Study site

    Frederick, Maryland, 21701

  • Study site

    Las Vegas, Nevada, 89135

  • Study site

    Portland, Oregon, 97239

  • Study site

    Sacramento, California, 95817

  • Study site

    Seattle, Washington, 98101

Other trials in United States

France8 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Lille, 59020

  • Study site

    Lyon, 69008

  • Study site

    Marseille, 13273

  • Study site

    Nantes, 44805

  • Study site

    Paris, 75908

  • Study site

    Toulouse, 31052

  • Study site

    Villejuif, 94805

Other trials in France

Germany7 sites

  • Study site

    Berlin, State of Berlin, 12203

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Frankfurt am Main, Hesse, 60488

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81377

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Poland7 sites

  • Study site

    Gdansk, 80-210

  • Study site

    Krakow, 31-115

  • Study site

    Poznan, 61-878

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 50-043

Other trials in Poland

Russia5 sites

  • Study site

    Kazan', 420029

  • Study site

    Kirov, 610021

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 125284

  • Study site

    Saint Petersburg, 197758

Other trials in Russia

Ukraine4 sites

  • Study site

    Donetsk, 83092

  • Study site

    Kharkiv, 61024

  • Study site

    Kiev, 115

  • Study site

    Lviv, 79031

Other trials in Ukraine

United Kingdom2 sites

  • Study site

    London, London, SW3 6JJ

  • Study site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

The purpose of the study is to:

  • Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
  • Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
  • Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
  • Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
  • Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
  • Find out the level of BAY43-9006 in the blood once per month and any changes in this level
  • Find out whether BAY43-9006 effects are associated with specific biomarkers
Read the detailed description

Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial.

Being tested
Sorafenib (Nexavar, BAY43-9006), Interferon
Keywords
Renal Cell Cancer, RCC, Cancer
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Multi kinase inhibitor

  • InterferonDrug

    Interferon

Study groups in NCT00117637
Study groupRoleWhat they receive
First Sorafenib (Nexavar, BAY43-9006) 400 mg then 600 mgExperimentalSubjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
First Interferon then Sorafenib (Nexavar, BAY43-9006) 400 mgActive comparatorInterferon (IFN) α-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period.After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
Receives: Drug: Interferon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period

    Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

Secondary outcomes (33)

  1. Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period

    Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  2. Disease Control (DC) According to Independent Central Review for the First Intervention Period

    Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  3. Disease Control (DC) According to the Investigator Assessment for the First Intervention Period

    Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  4. Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period

    Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  5. Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period

    The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions:" I have been short in breath" and "I have been coughing"; its score ranges from 0 to 8.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  6. Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period

    The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions:" I have been short in breath" and "I have been coughing"; its score ranges from 0 to 8.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  7. Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period

    The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  8. Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period

    The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  9. Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period

    The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  10. Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period

    The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  11. Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  12. Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  13. Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  14. Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  15. Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  16. Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  17. Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  18. Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period

    The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  19. Tumor Response According to the Independent Radiological Review for the First Intervention Period

    Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  20. Tumor Response According to the Investigator Assessment for the First Intervention Period

    Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  21. Tumor Response According to the Investigator Assessment for the Second Intervention Period

    Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  22. Progression Free Survival According to the Investigator Assessment (Second Intervention Period)

    Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  23. Overall Survival (OS)

    Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  24. Slope - Change in Trough Concentration/Cycle

    Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.

    Measured: From start of treatment of the first subject until 15 months later assessed every 4 weeks.

  25. Average of All Trough Plasma Concentrations

    Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).

    Measured: From start of treatment of the first subject until 15 months later assessed every 4 weeks.

  26. Duration of Response According to the Independent Radiological Review for the First Intervention Period

    Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  27. Duration of Response According to the Investigator Assessment for the First Intervention Period

    Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  28. Duration of Response According to the Investigator Assessment for the Second Intervention Period

    Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks

  29. Time to Response According to the Independent Radiological Review for the First Intervention Period

    Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented

    Measured: From randomization of the first subject until 15 months later, assessed every 8 weeks

  30. Time to Response According to the Investigator Assessment for the First Intervention Period

    Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

  31. Time to Response According to the Investigator Assessment for the Second Intervention Period

    Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

  32. Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period

    Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

  33. Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period

    Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).

    Measured: From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionSep 2006
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117637
Sponsor's protocol ID
11848
Other IDs
2005-000544-86, 2005
Status last verified
Oct 2014
First submitted
30 Jun 2005
Last updated
31 Oct 2014
Data monitoring committee
Yes

Publications

  • Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, Negrier S, Laferriere N, Scheuring UJ, Cella D, Shah S, Bukowski RM. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Mar 10;27(8):1280-9. doi: 10.1200/JCO.2008.19.3342. Epub 2009 Jan 26.

    PubMed 19171708

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) and Interferon in people with Carcinoma, Renal Cell, run by Bayer at 42 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, France, Germany, Poland, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period (time frame: From randomization of the first subject until 15 months later, assessed every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00117637, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

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