Study of SU011248 in Patients With Advanced Kidney Cancer

Pfizer51 enrolled

Overview

To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Renal Cell

Interventions

SU011248 capsuleDRUG

50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven renal cell carcinoma with metastases with a component of clear cell histology Exclusion Criteria: * Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.

Locations (11)

Pfizer Investigational Site

Akita, Akita, Japan

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Pfizer Investigational Site

Tsukuba, Ibaragi, Japan

Pfizer Investigational Site

Outcomes

Primary Outcomes

Number of Subjects With Objective Response

Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Day 28 of Cycles 1-4

Secondary Outcomes

Progression-Free Survival (PFS)

Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.

Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

Time To Tumor Progression (TTP)

Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).

Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

Duration of Response (DR)

Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Sayama, Osaka, Japan

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Pfizer Investigational Site

Tokushima, Tokushima, Japan

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Pfizer Investigational Site

Yamagata, Yamagata, Japan

...and 1 more locations

Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.

Time to Tumor Response (TTR)

Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.

Overall Survival Time

Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.

Time frame: once year. Up to 3 years after the completion of subject registration.

Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score

Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.

Time frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4

Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)

Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline. The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

Time frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4

Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population

Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration