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Carcinoma, Renal CellPhase 3NCT00586105

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

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 8 sites in 2 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

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. 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)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesin 2 countries
Study dates
Dec 2005to May 2008
Phase
Phase 3
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 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

China4 sites

  • Study site

    Beijing, 100021

  • Study site

    Nanjing, Jiangsu, 210003

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200127

Other trials in China

Taiwan4 sites

  • Study site

    Tainan, Tainan, 70428

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

About this study

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

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.

Being tested
Sorafenib (Nexavar, BAY43-9006)
Keywords
Sorafenib, Nexavar, Metastatic RCC, Renal Cell Carcinoma, Unresectable RCC
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

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

Study groups in NCT00586105
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)Experimental400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

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

  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]).

    Measured: 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.

    Measured: 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)].

    Measured: 12 hours after at least 21 days of uninterrupted dosing

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

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

  1. First posted4 Jan 2008 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2008
  4. Study completionMay 2008

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00586105
Sponsor's protocol ID
11559
Status last verified
Mar 2014
First submitted
21 Dec 2007
Last updated
16 Apr 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 8 sites in 2 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 12 inclusion and 21 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Oct 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?

Pharmacokinetics Measured as Area Under Curve (AUC[0-12h]) (time frame: 12 hours after at least 21 days of uninterrupted dosing). The study lists 3 primary outcomes in all. 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 NCT00586105.

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 16 Apr 2014.

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