Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

Sorafenib (Nexavar, BAY43-9006)

Bayer Study Director

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.

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

A Multicenter Uncontrolled Study of Sorafenib in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

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 \[kg\]).

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.

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 \[dose (mg)/weight (kg)\].

Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.

Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.

Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.

The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).

The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.

Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.

Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.

Bayer

Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)

Age, Continuous

Sex: Female, Male

Taiwan

China

Region of Enrollment

ECOG 0

ECOG 1

Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory).

Eastern Cooperative Oncology Group (ECOG) Scale

Low-risk (no risk factors)

Intermediate-risk (1 or 2 risk factors)

The 5 Motzer risk factors correlate with overall survival in metastatic RCC. Patients with no factors (low-risk) have a favorable survival risk, patients with 1 or 2 risk factors survive a shorter time and constitute an intermediate-risk group, and those with 3 or more risk factors have the poorest survival and represent a poor-risk group.

Motzer risk factors

Clear cell

Predominantly clear cell

Patients were categorized into 1 or 2 subgroups depending on the tumor histology: Clear cell or predominantly clear cell.

Renal Cell Carcinoma subtype

Time since first progression was defined as the time from the first progression of the patient's disease after initial diagnosis until randomization into this study.

Time since first progression

Time since initial diagnosis was the mean time from initial diagnosis to randomization into the study.

Time since initial diagnosis

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.

Therapeutic Area Head

AUC (0-12h)

AUC norm

A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.

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

Cmax

Cmin

A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.

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

Cmax norm

Cmin norm

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

All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.

Progression Free Survival (PFS)

Overall Survival (OS)

Time to Progression (TTP)

disease control

no disease control

not evaluated

Disease Control (DC)

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Overall Best Response

All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.

Overall Response Duration

All subjects who received at least 1 dose of drug (the intent to treat \[ITT\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.

Spots Global Cancer Trial Database for Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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