Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

NCT00586105 | Completed Phase 3 Results

• 1 other identifier: 11559
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 8

Brief Summary

A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.

Conditions

Carcinoma, Renal Cell

Keywords

Sorafenib; Nexavar; Metastatic RCC; Renal Cell Carcinoma; Unresectable RCC

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])

  The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose \[mg\]/weight \[kg\]).

  12 hours after at least 21 days of uninterrupted dosing

• Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)

  Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.

  12 hours after at least 21 days of uninterrupted dosing

• Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)

  Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by \[dose (mg)/weight (kg)\].

  12 hours after at least 21 days of uninterrupted dosing

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months

• Overall Survival (OS)

  Time from start of therapy to death up to 17.25 months

• Time to Progression (TTP)

  Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months

• Disease Control (DC)

  From start to end of study medication up to 17.25 months

• Overall Best Response

  Best response observed from start to end of study medication up to 17.25 months

Study Arms (1)

Sorafenib (Nexavar, BAY43-9006)

EXPERIMENTAL

400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Sorafenib (Nexavar, BAY43-9006)

Eligibility Criteria

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

You may qualify if:

• Patients who have a life expectancy of at least 12 weeks
• Patients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.
• Patients who have received not more than one prior systemic therapy for advanced disease which was completed at least 30 days prior to the first dose of study medication.
• Patients who have at least one uni-dimensional measurable lesion by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST)
• Patients with "Intermediate" or "low" risk per the Motzer score
• Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
• Adequate bone marrow, liver and renal function at screening as assessed by the following:
• Total bilirubin \< 1.5 x the upper limit of normal.
• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \< 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.
• Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) \< 1.5 x upper limit of normal

You may not qualify if:

• Previous or concurrent cancer that is distinct in primary sit or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors \[Ta (Noninvasive papillary carcinoma), Tis (Carcinoma in situ: "flat tumor") and T1 (Tumor invades subepithelial connective tissue)\] or any cancer curatively treated \> 3 years prior to study entry)
• Patients who completed their prior systemic treatment regimen less than 30 days
• Cardiac arrhythmias requiring anti-arrhythmic (excluding beta blockers or digoxin), symptomatic coronary artery disease or ischemia
• Active clinically serious bacterial or fungal infections
• Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C requiring current interferon treatment
• Symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has a negative imaging studies within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
• Patients with evidence or history of bleeding diathesis.
• Patients with seizure disorder requiring medication
• 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
• Pregnant or breast-feeding patients.
• Excluded concomitant medications:
• Concurrent anti-cancer chemotherapy, immunotherapy, or hormonal therapy except Bisphosphonates
• Radiotherapy during study or within 3 weeks of start of study drug.
• Biological response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CFS) or Granulocyte macrophage colony-stimulating factor (GM-CFS), within 3 weeks prior to study entry or during study

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

Nanjing, Jiangsu, 210003, China

Location

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Shanghai, 200127, China

Location

Unknown Facility

Tainan, Tainan, 70428, Taiwan

Location

Unknown Facility

Taipei, 10002, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

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

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

Limitations and Caveats

The median for ´Overall Survival (OS)´ and the median for ´Overall Response Duration´ reported are the median of each distribution including the censored data. The correct estimates of these medians were not evaluable.

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: LTE60
• 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: December 21, 2007
• First Posted: January 4, 2008
• Study Start: December 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: October 1, 2010

Record last verified: 2014-03

Locations

TW (4); CN (4)