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Carcinoma, Renal CellPhase 2NCT00618982

Sorafenib Dose Escalation in Renal Cell Carcinoma

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 22 sites in 5 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

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. 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
83 participants
Where
22 sitesin 5 countries
Study dates
Feb 2008to Jan 2011
Phase
Phase 2
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

  • Age > 18 years.
  • Metastatic clear cell RCC (renal cell carcinoma)
  • Subjects with at least one uni-dimensional measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Memorial Sloan Kettering Cancer Center (MSKCC) good or intermediate category
  • Life expectancy of at least 12 weeks.
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  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to treatment
  • Signed informed consent must be obtained prior to any study specific procedures.
  • Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma
  • Prior total nephrectomy

Who cannot join

  • History of cardiac disease
  • History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Active clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 3.0)
  • Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
  • Subjects with evidence or history of bleeding diathesis
  • Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment.
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  • Delayed healing of wounds, ulcers or bone fractures
  • Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication
  • Subjects undergoing renal dialysis
  • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to 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 and three months after the completion of trial.
  • Prior adjuvant sorafenib is excluded.
  • Radiotherapy during study or within 3 weeks of start of study drug
  • Major surgery within 4 weeks of start of study
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

France6 sites

  • Study site

    Bordeaux, 33000

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    Marseille, 13385

  • Study site

    Nantes, 44805

  • Study site

    Paris, 75475

  • Study site

    Tours, 37044

Other trials in France

Germany5 sites

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Jena, Thuringia, 07740

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Marburg, Hesse, 35043

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Poland4 sites

  • Study site

    Olsztyn, 10-226

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 50 - 556

Other trials in Poland

United Kingdom4 sites

  • Study site

    Cardiff, South Glamorgan, CF14 7TB

  • Study site

    Glasgow, G12 0YN

  • Study site

    Greater Manchester, Manchester, M20 4BX

  • Study site

    London, London, SW3 6JJ

Other trials in United Kingdom

Italy3 sites

  • Study site

    Aviano, Pordenone, 33081

  • Study site

    Milan, 20133

  • Study site

    Pavia, 27100

Other trials in Italy

About this study

Official title: A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

Read the detailed description

Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.

Being tested
Sorafenib (Nexavar, BAY43-9006)
Keywords
Kidney cancer,, Sorafenib,, Dose escalation,, No previous treatment
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

    The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.

Study groups in NCT00618982
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalIntrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

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

  1. Best Response - mITT (Modified Intent-to-treat) Population

    Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.

    Measured: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.

  2. Tumor Response - ITT (Intent to Treat) Population

    Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.

    Measured: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.

Secondary outcomes (6)

  1. Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)

    AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

    Measured: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.

  2. Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)

    AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

    Measured: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.

  3. Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax)

    Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

    Measured: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.

  4. Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax)

    Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

    Measured: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.

  5. Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.

    Measured: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.

  6. Time to Progression (TTP)

    Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.

    Measured: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.

Timeline

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

  1. First posted20 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2009
  4. Study completionJan 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00618982
Sponsor's protocol ID
12913
Other IDs
2007-004875-21
Status last verified
Nov 2015
First submitted
8 Feb 2008
Last updated
24 Dec 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 22 sites in 5 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 10 inclusion and 14 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France, Germany, Poland, United Kingdom, Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 27 May 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?

Best Response - mITT (Modified Intent-to-treat) Population (time frame: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.). The study lists 2 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 NCT00618982.

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 24 Dec 2015.

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