To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
64
AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID. Number of cycles: until progression or unacceptable toxicity develops.
National Cancer Center East Hospital
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Time frame: Up to 765 days of treatment at the data cut-off date
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Time frame: Up to 765 days of treatment at the data cut-off date
Progression-Free Survival (PFS)
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease \[PD\]).
Time frame: Up to 1709 days of treatment
Time to Tumor Progression (TTP)
Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease \[PD\]).
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Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University
Morioka, Iwate, Japan
Kochi Medical School Hospital
Nankoku-shi, Kochi, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Hamamatsu University School of Medicine University Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, Japan
National Cancer Center
Chuo-ku, Tokyo, Japan
...and 8 more locations
Time frame: Up to 1709 days of treatment
Duration of Response
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.
Overall Survival (OS)
OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause. Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive.
Time frame: Up to 2002 days (maximum duration of treatment plus follow-up observation)
Number of Participants Analyzed for Population Pharmacokinetics of AG-013736
Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.
Time frame: Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)
Time frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)
Time frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)
Time frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)
Time frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)
Time frame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Number of Participants With Adverse Events
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.
Time frame: Up to 1709 days of treatment plus 28-days follow-up