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Carcinoma, Renal CellPhase 2NCT00661375

BAY43-9006 Phase II Study for Renal Cell Carcinoma

A Phase 2 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 51 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

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen. 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?
Nexavar (Sorafenib, BAY43-9006)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
51 sitesJapan
Study dates
Nov 2004to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 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.

Who cannot join

  • More than three regimens of previous treatment for RCC

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Japan51 sites

  • Study site

    Akita, Akita, 010-8543

  • Study site

    Asahi, Chiba, 289-2511

  • Study site

    Chiba, Chiba, 260-0801

  • Study site

    Chiba, Chiba, 260-8677

  • Study site

    Fukuoka, Fukuoka, 812-0033

  • Study site

    Fukuoka, Fukuoka, 812-8582

  • Study site

    Hamamatsu, Shizuoka, 431-3192

  • Study site

    Irima-gun, Saitama, 350-0495

  • Study site

    Isesaski, Gunma, 372-0817

  • Study site

    Kagoshima, Kagoshima-ken, 890-8520

  • Study site

    Kashihara, Nara, 634-8522

  • Study site

    Kita, Kagawa-ken, 761-0793

  • 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

    Nagasaki, Nagasaki, 852-8501

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nakakoma, Yamanashi, 409-3898

  • Study site

    Natori-shi, Miyagi, 981-1293

  • Study site

    Niigata, Niigata, 951-8520

  • 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, 060-8604

  • Study site

    Sapporo, Hokkaido, 060-8648

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Sendai, Miyagi, 980-8574

  • 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

    Tokyo, 104-0045

  • Study site

    Tokyo, 113-8603

  • Study site

    Tokyo, 113-8655

  • Study site

    Tokyo, 116-8567

  • Study site

    Tokyo, 160-8582

  • Study site

    Tokyo, 162-8666

  • Study site

    Tokyo, 173-0003

  • 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

    Wakayama, Wakayama, 640-8558

  • Study site

    Wakayama, Wakayama, 641-8510

  • Study site

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.

Being tested
Nexavar (Sorafenib, BAY43-9006)
Keywords
BAY 43-9006, Phase II, Renal cell carcinoma, Response rate
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.

  • Nexavar (Sorafenib, BAY43-9006)Drug

    BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.

Study groups in NCT00661375
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Nexavar (Sorafenib, BAY43-9006)

What is being measured

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

  1. Tumor response rate

    Measured: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

Secondary outcomes (6)

  1. Time to progression

    Measured: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

  2. Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma

    Measured: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

  3. Time to death

    Measured: At the time of death

  4. Overall response duration and time to objective response

    Measured: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

  5. Overall disease control rate

    Measured: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

  6. FACT-G and FKSI

    Measured: Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.

Timeline

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

  1. First posted18 Apr 2008 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2006
  4. Study completionMar 2006

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
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00661375
Sponsor's protocol ID
11515
Status last verified
Dec 2014
First submitted
4 Apr 2008
Last updated
25 Dec 2014
Results posted
No
Data monitoring committee
Yes

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

  • Iijima M, Fukino K, Adachi M, Tsukamoto T, Murai M, Naito S, Minami H, Furuse J, Akaza H. Sorafenib-associated hand-foot syndrome in Japanese patients. J Dermatol. 2011 Mar;38(3):261-6. doi: 10.1111/j.1346-8138.2010.01059.x. Epub 2010 Nov 2.

    PubMed 21342228

  • Akaza H, Tsukamoto T, Murai M, Nakajima K, Naito S. Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Jpn J Clin Oncol. 2007 Oct;37(10):755-62. doi: 10.1093/jjco/hym095. Epub 2007 Oct 19.

    PubMed 17951335

  • Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.

    PubMed 21467949

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 51 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 2 inclusion and 1 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 25 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 51 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tumor response rate (time frame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.). 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 NCT00661375, which also lists 4 linked publications.

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 25 Dec 2014.

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