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CompletedNCT00586105Updated Apr 16, 2014Results posted

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

A Phase 3 interventional study of Sorafenib (Nexavar, BAY43-9006) in Carcinoma, Renal Cell, sponsored by Bayer. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-16.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Renal Cell

Keywords

  • Sorafenib
  • Nexavar
  • Metastatic RCC
  • Renal Cell Carcinoma
  • Unresectable RCC
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 39 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Significant surgery within 4 weeks prior to start of study drug
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Investigational drug therapy during or within 4 weeks prior to first drug administration and during the study
  • St John's Wort
  • Xiao Chai Hu Tang
  • Prior and concomitant use of Bevacizumab, and all other drugs (investigational or licensed) that target Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptors, Raf-kinase inhibitors (RKI), Methyl Ethyl Ketone (MEK) or Farnesyl transferase inhibitors
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Sorafenib (Nexavar, BAY43-9006)

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

    Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

  • DrugSorafenib (Nexavar, BAY43-9006)

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

06

What researchers measure

Primary outcomes

  1. 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 \[kg\]).

    Time frame: 12 hours after at least 21 days of uninterrupted dosing

  2. 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.

    Time frame: 12 hours after at least 21 days of uninterrupted dosing

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

    Time frame: 12 hours after at least 21 days of uninterrupted dosing

Secondary outcomes

  1. Progression Free Survival (PFS)

    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.

    Time frame: 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

  2. Overall Survival (OS)

    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 frame: Time from start of therapy to death up to 17.25 months

  3. Time to Progression (TTP)

    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.

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

  4. Disease Control (DC)

    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).

    Time frame: From start to end of study medication up to 17.25 months

  5. Overall Best Response

    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.

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

  6. Overall Response Duration

    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 frame: From PR or CR to progression or death up to 17.25 months

  7. Time to Objective Response

    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.

    Time frame: Time from start of study medication to first documented PR or CR up to 17.25 months

07

Results

Posted Oct 1, 2010
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.

Participant flow

Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.

Participant flow — Overall Study
MilestoneSorafenib (Nexavar, BAY43-9006)
Started39
Completed0
Not completed39
Withdrew: Adverse event4
Withdrew: Death2
Withdrew: Protocol violation1
Withdrew: Withdrawal by subject3
Withdrew: Disease progression19
Withdrew: Switched to commercial drug9
Withdrew: Reason not reported1

Outcome measures

PrimaryPharmacokinetics 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 \[kg\]).

Time frame:
12 hours after at least 21 days of uninterrupted dosing
Reported as:
Mean · mg*hour/Liter
Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])
mg*hour/LiterSorafenib (Nexavar, BAY43-9006)
AUC (0-12h)35.5 ± 16.1
AUC norm5.7 ± 3.0
PrimaryPharmacokinetics 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.

Time frame:
12 hours after at least 21 days of uninterrupted dosing
Reported as:
Mean · mg/L
Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)
mg/LSorafenib (Nexavar, BAY43-9006)
Cmax4.5 ± 2.4
Cmin2.0 ± 0.9
PrimaryPharmacokinetics 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 \[dose (mg)/weight (kg)\].

Time frame:
12 hours after at least 21 days of uninterrupted dosing
Reported as:
Mean · Kg/L
Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)
Kg/LSorafenib (Nexavar, BAY43-9006)
Cmax norm0.7 ± 0.5
Cmin norm0.3 ± 0.2
SecondaryProgression Free Survival (PFS)

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.

Time frame:
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
Reported as:
Median · months
Progression Free Survival (PFS)
monthsSorafenib (Nexavar, BAY43-9006)
Progression Free Survival (PFS)5.5 (4.1 to 7.8)
SecondaryOverall Survival (OS)

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 frame:
Time from start of therapy to death up to 17.25 months
Reported as:
Median · months
Overall Survival (OS)
monthsSorafenib (Nexavar, BAY43-9006)
Overall Survival (OS)7.8 (0.9 to 13.4)
SecondaryTime to Progression (TTP)

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.

Time frame:
Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months
Reported as:
Median · months
Time to Progression (TTP)
monthsSorafenib (Nexavar, BAY43-9006)
Time to Progression (TTP)5.5 (4.1 to 7.4)
SecondaryDisease Control (DC)

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).

Time frame:
From start to end of study medication up to 17.25 months
Reported as:
Number · participants
Disease Control (DC)
participantsSorafenib (Nexavar, BAY43-9006)
disease control32
no disease control6
not evaluated1
SecondaryOverall Best Response

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.

Time frame:
Best response observed from start to end of study medication up to 17.25 months
Reported as:
Number · participants
Overall Best Response
participantsSorafenib (Nexavar, BAY43-9006)
Complete Response (CR)0
Partial Response (PR)5
Stable Disease (SD)27
Progressive Disease (PD)6
not evaluated1
SecondaryOverall Response Duration

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 frame:
From PR or CR to progression or death up to 17.25 months
Reported as:
Median · months
Overall Response Duration
monthsSorafenib (Nexavar, BAY43-9006)
Overall Response Duration7.4 (5.4 to 12.9)
SecondaryTime to Objective Response

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.

Time frame:
Time from start of study medication to first documented PR or CR up to 17.25 months
Reported as:
Median · months
Time to Objective Response
monthsSorafenib (Nexavar, BAY43-9006)
Time to Objective Response1.4 (1.3 to 18.3)

Adverse events

Collected over From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sorafenib (Nexavar, BAY43-9006)—12/39 (30.8%)39/39 (100%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventSorafenib (Nexavar, BAY43-9006)
FeverGeneral disorders3/39
No Code In CTCAEGeneral disorders3/39
Pulmonary - OtherRespiratory, thoracic and mediastinal disorders2/39
HemoglobinBlood and lymphatic system disorders1/39
PlateletsBlood and lymphatic system disorders1/39
AnorexiaGastrointestinal disorders1/39
Obstruction, GI, Small Bowel NOSGastrointestinal disorders1/39
Pain, Abdomen NOSGeneral disorders1/39
Infection With Normal ANC, Biliary TreeInfections and infestations1/39
Infection With Normal ANC, ParanasalInfections and infestations1/39
Most frequent other events
Showing 10 of 62
Most frequent other events
EventSorafenib (Nexavar, BAY43-9006)
Hand-Foot Skin ReactionSkin and subcutaneous tissue disorders25/39
DiarrheaGastrointestinal disorders14/39
AlopeciaSkin and subcutaneous tissue disorders14/39
FatigueGeneral disorders12/39
AnorexiaGastrointestinal disorders11/39
CoughRespiratory, thoracic and mediastinal disorders11/39
HemoglobinBlood and lymphatic system disorders9/39
ConstipationGastrointestinal disorders9/39
Weight LossGeneral disorders9/39
HypophosphatemiaMetabolism and nutrition disorders9/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sorafenib (Nexavar, BAY43-9006)
Mean58 ± 14.5
Sex: Female, Male
Sex: Female, Male(Participants)Sorafenib (Nexavar, BAY43-9006)
Female9
Male30
Region of Enrollment
Region of Enrollment(participants)Sorafenib (Nexavar, BAY43-9006)
Taiwan19
China20
Eastern Cooperative Oncology Group (ECOG) Scale
Eastern Cooperative Oncology Group (ECOG) Scale(participants)Sorafenib (Nexavar, BAY43-9006)
ECOG 020
ECOG 119
Motzer risk factors
Motzer risk factors(participants)Sorafenib (Nexavar, BAY43-9006)
Low-risk (no risk factors)21
Intermediate-risk (1 or 2 risk factors)18
Renal Cell Carcinoma subtype
Renal Cell Carcinoma subtype(participants)Sorafenib (Nexavar, BAY43-9006)
Clear cell34
Predominantly clear cell5
Time since first progression
Time since first progression(years)Sorafenib (Nexavar, BAY43-9006)
Mean0.4 ± 0.6
Time since initial diagnosis
Time since initial diagnosis(years)Sorafenib (Nexavar, BAY43-9006)
Mean1.7 ± 2.5
08

Study locations

8 sites
  • Nanjing, Jiangsu 210003, China
  • Beijing, 100021, China
  • Shanghai, 200032, China
  • Shanghai, 200127, China
  • Tainan, 70428, Taiwan
  • Taipei, 10002, Taiwan
  • Taipei, 112, Taiwan
  • Taoyuan, 333, Taiwan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00586105
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jan 4, 2008
Start date
Dec 2005
Primary completion
May 2008
Completion
May 2008
Results posted
Oct 1, 2010
Last update
Apr 16, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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