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BAY43-9006 Phase II Study for Renal Cell Carcinoma

Primary Purpose

Carcinoma, Renal Cell

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Nexavar (Sorafenib, BAY43-9006)

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring BAY 43-9006, Phase II, Renal cell carcinoma, Response rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

More than three regimens of previous treatment for RCC

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Tumor response rate

Secondary Outcome Measures

Time to progression

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

Time to death

Overall response duration and time to objective response

Overall disease control rate

FACT-G and FKSI

Full Information

NCT ID

NCT00661375

First Posted

April 4, 2008

Last Updated

December 23, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00661375

Brief Title

BAY43-9006 Phase II Study for Renal Cell Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

BAY 43-9006, Phase II, Renal cell carcinoma, Response rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nexavar (Sorafenib, BAY43-9006)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Time to progression

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.

Title

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.

Title

Time to death

Time Frame

At the time of death

Title

Overall response duration and time to objective response

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.

Title

Overall disease control 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.

Title

FACT-G and FKSI

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: More than three regimens of previous treatment for RCC

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

City

Asahi

State/Province

Chiba

ZIP/Postal Code

289-2511

Country

Japan

City

Matsuyama

State/Province

Ehime

ZIP/Postal Code

791-0280

Country

Japan

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

City

Isesaski

State/Province

Gunma

ZIP/Postal Code

372-0817

Country

Japan

City

Maebashi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0804

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8543

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

City

Sunagawa

State/Province

Hokkaido

ZIP/Postal Code

073-0196

Country

Japan

City

Tsukuba

State/Province

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

City

Morioka

State/Province

Iwate

ZIP/Postal Code

020-8505

Country

Japan

City

Kita

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

City

Tsu

State/Province

Mie

ZIP/Postal Code

514-8507

Country

Japan

City

Natori

State/Province

Miyagi

ZIP/Postal Code

981-1293

Country

Japan

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

City

Kashihara

State/Province

Nara

ZIP/Postal Code

634-8522

Country

Japan

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

City

Irima-gun

State/Province

Saitama

ZIP/Postal Code

350-0495

Country

Japan

City

Tokorozawa

State/Province

Saitama

ZIP/Postal Code

359-8513

Country

Japan

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

City

Sunto

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

City

Utsunomiya

State/Province

Tochigi

ZIP/Postal Code

320-0834

Country

Japan

City

Ube

State/Province

Yamaguchi

ZIP/Postal Code

755-8505

Country

Japan

City

Nakakoma

State/Province

Yamanashi

ZIP/Postal Code

409-3898

Country

Japan

City

Akita

ZIP/Postal Code

010-8543

Country

Japan

City

Chiba

ZIP/Postal Code

260-0801

Country

Japan

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

City

Fukuoka

ZIP/Postal Code

812-0033

Country

Japan

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

City

Niigata

ZIP/Postal Code

951-8520

Country

Japan

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

City

Osaka

ZIP/Postal Code

537-8511

Country

Japan

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

City

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

City

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

City

Tokyo

ZIP/Postal Code

116-8567

Country

Japan

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

City

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

City

Tokyo

ZIP/Postal Code

173-0003

Country

Japan

City

Wakayama

ZIP/Postal Code

640-8558

Country

Japan

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

City

Yamagata

ZIP/Postal Code

990-9585

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

21481133

Citation

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.

Results Reference

background

PubMed Identifier

21342228

Citation

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.

Results Reference

result

PubMed Identifier

17951335

Citation

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.

Results Reference

result

PubMed Identifier

21467949

Citation

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.

Results Reference

result

Learn more about this trial

BAY43-9006 Phase II Study for Renal Cell Carcinoma

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