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AzTrials

Carcinoma, Renal CellPhase 2NCT00678288

A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) and Sorafenib (Nexavar, BAY43-9006) + Interferon in people with Carcinoma, Renal Cell, run by Bayer at 35 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. 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) and Sorafenib (Nexavar, BAY43-9006) + Interferon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
35 sitesin 7 countries
Study dates
Apr 2008to Jun 2009
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

  • Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
  • And/or patients who have discontinued sunitinib treatment at any point due to toxicity
  • Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
  • Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Who cannot join

  • Patient should be excluded if they have unresolved chronic toxicity grade
  • > 1 and related to prior therapy with sunitinib.

Trial locations and contacts

35 sites in 7 countries.

35 sites in 7 countries

France12 sites

  • Study site

    Avignon, 84000

  • Study site

    Bayonne, 64100

  • Study site

    Bordeaux, 33000

  • Study site

    Marseille, 13015

  • Study site

    Marseille, 13385

  • Study site

    Nantes, 44020

  • Study site

    Paris, 75014

  • Study site

    Paris, 75651

  • Study site

    Reims, 51100

  • Study site

    Strasbourg, 67000

  • Study site

    Toulouse, 31052

  • Study site

    Vandœuvre-lès-Nancy, 54000

Other trials in France

Italy6 sites

  • Study site

    Aviano, Pordenone, 33081

  • Study site

    Legnago, Verona, 37045

  • Study site

    Naples, 80131

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06156

  • Study site

    Reggio Emilia, 42100

Other trials in Italy

Spain6 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Oviedo, Oviedo, 33006

  • Study site

    Pamplona, Pamplona, 31008

  • Study site

    Valencia, Valencia, 46009

Other trials in Spain

Poland4 sites

  • Study site

    Gdansk, 80-219

  • Study site

    Lublin, 20-090

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 50 - 556

Other trials in Poland

United Kingdom3 sites

  • Study site

    London, London, SW3 6JJ

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE4 6BE

  • Study site

    Northwood, Middlesex, HA6 2RN

Other trials in United Kingdom

Austria2 sites

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, State of Vienna, 1090

Other trials in Austria

Ireland2 sites

  • Study site

    Cork

  • Study site

    Dublin, Dublin, 24

Other trials in Ireland

About this study

Official title: A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

Being tested
Sorafenib (Nexavar, BAY43-9006), Sorafenib (Nexavar, BAY43-9006) + Interferon
Keywords
Renal Cell Cancer, Interferon
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

    Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously

  • Sorafenib (Nexavar, BAY43-9006) + InterferonDrug

    Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

Study groups in NCT00678288
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) + InterferonExperimentalSorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon

What is being measured

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

  1. Progression-Free Survival

    Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.

    Measured: From start of treatment of the first subject until 14 months later, assessed every 8 weeks

Secondary outcomes (4)

  1. Response Rate

    Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

    Measured: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

  2. Time to Progression

    Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

    Measured: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

  3. Duration of Response

    Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.

    Measured: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

  4. Overall Survival

    Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

Timeline

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

  1. First posted15 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00678288
Sponsor's protocol ID
12782
Other IDs
2007-005083-28, CONCERT
Status last verified
Nov 2014
First submitted
14 May 2008
Last updated
11 Dec 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) and Sorafenib (Nexavar, BAY43-9006) + Interferon in people with Carcinoma, Renal Cell, run by Bayer at 35 sites in 7 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Italy, Spain, Poland, United Kingdom and 2 more countries. 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 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?

Progression-Free Survival (time frame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks). 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 NCT00678288.

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 11 Dec 2014.

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