Long-term Extension From RCC Phase II (11515)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00586495
First received: December 21, 2007
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).


Secondary Outcome Measures:
  • Best Tumor Response [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    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)

  • Overall Survival (OS) [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 3 months ] [ Designated as safety issue: No ]
    Time from initiation of treatment to death due to any cause.

  • Overall Response Duration [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Time to Objective Response [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Overall Disease Control [ Time Frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 95
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib (Nexavar, BAY43-9006)
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
Drug: Sorafenib (Nexavar, BAY43-9006)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Patients who are willing to continue the study drug,
  2. Patients for whom the investigator consider continuation of the study drug is appropriate
  3. Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
  4. 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.

Exclusion Criteria:

  1. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  2. Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
  3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586495

Locations
Japan
Asahi, Chiba, Japan, 289-2511
Matsuyama, Ehime, Japan, 791-0280
Kurume, Fukuoka, Japan, 830-0011
Isesaki, Gunma, Japan, 372-0817
Maebashi, Gunma, Japan, 371-8511
Sapporo, Hokkaido, Japan, 060-8648
Sapporo, Hokkaido, Japan, 060-8543
Sapporo, Hokkaido, Japan, 003-0804
Sunagawa, Hokkaido, Japan, 073-0196
Tsukuba, Ibaraki, Japan, 305-8576
Morioka, Iwate, Japan, 020-8505
Tsu, Mie, Japan, 514-8507
Natori, Miyagi, Japan, 981-1293
Kashihara, Nara, Japan, 634-8522
Kurashiki, Okayama, Japan, 710-8602
Osakasayama, Osaka, Japan, 589-8511
Suita, Osaka, Japan, 565-0871
Hidaka, Saitama, Japan, 350-1298
Irima-gun, Saitama, Japan, 350-0495
Tokorozawa, Saitama, Japan, 359-8513
Hamamatsu, Shizuoka, Japan, 431-3192
Sunto, Shizuoka, Japan, 411-8777
Utsunomiya, Tochigi, Japan, 320-0834
Arakawa-ku, Tokyo, Japan, 116-8567
Bunkyo-ku, Tokyo, Japan, 113-8655
Chuo-ku, Tokyo, Japan, 104-0045
Itabashi-ku, Tokyo, Japan, 173-0003
Shinjuku-ku, Tokyo, Japan, 162-8666
Ube, Yamaguchi, Japan, 755-8505
Akita, Japan, 010-8543
Chiba, Japan, 260-8717
Chiba, Japan, 260-8677
Fukuoka, Japan, 812-0033
Fukuoka, Japan, 812-8582
Kagoshima, Japan, 890-8520
Kyoto, Japan, 602-8566
Kyoto, Japan, 606-8507
Okayama, Japan, 700-8558
Osaka, Japan, 537-8511
Tokushima, Japan, 770-8503
Yamagata, Japan, 990-9585
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00586495     History of Changes
Other Study ID Numbers: 12056
Study First Received: December 21, 2007
Results First Received: October 8, 2009
Last Updated: November 19, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Sorafenib
Nexavar
Metastatic RCC
Renal Cell Carcinoma
Unresectable RCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014