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Carcinoma, Renal CellPhase 2NCT00586495

Long-term Extension From RCC Phase II (11515)

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 41 sites in Japan.

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

Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC). 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
95 participants
Where
41 sitesJapan
Study dates
Dec 2005to Jul 2008
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

  • Patients are classified into two groups as below at transition date from Study 11515 to this study.
  • Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
  • Population II: Patients who have been monitored only for survival status at the end of Study 11515.
  • Population 1
  • Patients who are willing to continue the study drug,
  • Patients for whom the investigator consider continuation of the study drug is appropriate
Show all 10Show fewer
  • Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
  • Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Population 2
  • 1. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Who cannot join

  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
  • Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Japan41 sites

  • Study site

    Akita, Akita, 010-8543

  • Study site

    Arakawa-ku, Tokyo, 116-8567

  • Study site

    Asahi, Chiba, 289-2511

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Chiba, Chiba, 260-8677

  • Study site

    Chiba, Chiba, 260-8717

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Fukuoka, Fukuoka, 812-0033

  • Study site

    Fukuoka, Fukuoka, 812-8582

  • Study site

    Hamamatsu, Shizuoka, 431-3192

  • Study site

    Hidaka, Saitama, 350-1298

  • Study site

    Irima-gun, Saitama, 350-0495

  • Study site

    Isesaki, Gunma, 372-0817

  • Study site

    Itabashi-ku, Tokyo, 173-0003

  • Study site

    Kagoshima, Kagoshima-ken, 890-8520

  • Study site

    Kashihara, Nara, 634-8522

  • Study site

    Kurashiki, Okayama-ken, 710-8602

  • Study site

    Kurume, Fukuoka, 830-0011

  • Study site

    Kyoto, Kyoto, 602-8566

  • Study site

    Kyoto, Kyoto, 606-8507

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Matsuyama, Ehime, 791-0280

  • Study site

    Morioka, Iwate, 020-8505

  • Study site

    Natori-shi, Miyagi, 981-1293

  • Study site

    Okayama, Okayama-ken, 700-8558

  • Study site

    Osaka, Osaka, 537-8511

  • Study site

    Sapporo, Hokkaido, 003-0804

  • Study site

    Sapporo, Hokkaido, 060-8543

  • Study site

    Sapporo, Hokkaido, 060-8648

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    Sunagawa, Hokkaido, 073-0196

  • Study site

    Sunto, Shizuoka, 411-8777

  • Study site

    Tokorozawa, Saitama, 359-8513

  • Study site

    Tokushima, Tokushima, 770-8503

  • Study site

    Tsu, Mie-ken, 514-8507

  • Study site

    Tsukuba, Ibaraki, 305-8576

  • Study site

    Ube, Yamaguchi, 755-8505

  • Study site

    Utsunomiya, Tochigi, 320-0834

  • Study site

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma

Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

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

    Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally

Study groups in NCT00586495
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

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

  1. Progression Free Survival (PFS)

    Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).

    Measured: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Secondary outcomes (5)

  1. Best Tumor Response

    Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

  2. Overall Survival (OS)

    Time from initiation of treatment to death due to any cause.

    Measured: From start of treatment of the first subject until 45 months later, assessed every 3 months

  3. Overall Response Duration

    Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.

    Measured: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

  4. Time to Objective Response

    Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.

    Measured: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

  5. Overall Disease Control

    Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.

    Measured: From start of treatment of the first subject until 45 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 posted4 Jan 2008 (estimated)
  2. Study startDec 2005
  3. Primary completionJun 2008
  4. Study completionJul 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00586495
Sponsor's protocol ID
12056
Status last verified
Nov 2013
First submitted
21 Dec 2007
Last updated
13 Dec 2013
Data monitoring committee
No

Publications

  • Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11.

    PubMed 21481133

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 41 sites in Japan.

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 3 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 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Japan. 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 2 Feb 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 (PFS) (time frame: From start of treatment of the first subject until 45 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 NCT00586495, which also lists 1 linked publication.

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 13 Dec 2013; AzTrials last refreshed its copy on 26 Oct 2026.

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