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Completed

NCT Number: NCT00586495

Long-term Extension From RCC Phase II (11515)

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

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Akita, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients who are willing to continue the study drug,
  • Patients for whom the investigator consider continuation of the study drug is appropriate
  • 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

  • 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

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Progression Free Survival (PFS)

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

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

Secondary outcomes

  1. Best Tumor Response

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

    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)

  2. Overall Survival (OS)

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

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

  3. Overall Response Duration

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

    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.

  4. Time to Objective Response

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

    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.

  5. Overall Disease Control

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

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2008
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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