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

NCT00117637 | Completed Phase 2 Results DMC

• 2 other identifiers: 118482005-000544-86
• Study Type: interventional
• Target: 189
• Locations: 7 countries
• Sites: 42

Brief 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 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

Conditions

Carcinoma, Renal Cell

Keywords

Renal Cell Cancer; RCC; Cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (33)

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

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

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

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

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

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

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

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

• 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

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

Study Arms (2)

First Sorafenib (Nexavar, BAY43-9006) 400 mg then 600 mg

EXPERIMENTAL

Subjects 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.

Drug: Sorafenib (Nexavar, BAY43-9006)

First Interferon then Sorafenib (Nexavar, BAY43-9006) 400 mg

ACTIVE COMPARATOR

Interferon (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 \[median\]).

Drug: Interferon

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Multi kinase inhibitor

First Sorafenib (Nexavar, BAY43-9006) 400 mg then 600 mg

Interferon DRUG

Interferon

First Interferon then Sorafenib (Nexavar, BAY43-9006) 400 mg

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (42)

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Sacramento, California, 95817, United States

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Aurora, Colorado, 80010, United States

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Chicago, Illinois, 60637, United States

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Frederick, Maryland, 21701, United States

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Las Vegas, Nevada, 89135, United States

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Cleveland, Ohio, 44195-0002, United States

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Portland, Oregon, 97239, United States

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Dallas, Texas, 75246, United States

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Seattle, Washington, 98101, United States

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Bordeaux, 33000, France

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Lille, 59020, France

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Lyon, 69008, France

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Marseille, 13273, France

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Nantes, 44805, France

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Paris, 75908, France

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Toulouse, 31052, France

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Villejuif, 94805, France

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Ulm, Baden-Wurttemberg, 89075, Germany

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München, Bavaria, 81377, Germany

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Hamburg, Hamburg, 20246, Germany

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Frankfurt am Main, Hesse, 60488, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Berlin, State of Berlin, 12203, Germany

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Gdansk, 80-210, Poland

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Krakow, 31-115, Poland

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Poznan, 61-878, Poland

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Szczecin, 70-111, Poland

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Warsaw, 02-781, Poland

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Warsaw, 04-141, Poland

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Wroclaw, 50-043, Poland

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Kazan', 420029, Russia

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Kirov, 610021, Russia

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Moscow, 115478, Russia

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Moscow, 125284, Russia

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Saint Petersburg, 197758, Russia

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Donetsk, 83092, Ukraine

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Kharkiv, 61024, Ukraine

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Kiev, 115, Ukraine

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Lviv, 79031, Ukraine

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London, London, SW3 6JJ, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 19171708 RESULT

• 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.

  PMID: 37146227 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Interventions

Sorafenib; Interferons

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 8, 2005
• Study Start: June 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: March 1, 2009
• Last Updated: October 31, 2014
• Results First Posted: December 15, 2010

Record last verified: 2014-10

Locations

US (9); DE (7); PL (7); RU (5); UA (4); GB (2); FR (8)