Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: AG-013736

• Registration Number: NCT00569946
• Lead Sponsor: Pfizer

Brief Summary

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Study Start: 2007-12-12
• Primary Completion: 2010-02-26
• Results First Submitted: 2012-02-25
• Results First Submitted QC: 2012-02-25
• Results First Posted: 2012-03-27
• Study Completion: 2012-10-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
• Patients who are refractory to cytokine therapy as 1st line.
• Patients who experienced nephrectomy.
• Patients with at least 1 target lesion, as defined by RECIST.
• Patients with no uncontrolled hypertension.

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Exclusion Criteria

• Gastrointestinal abnormalities
• Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
• Active seizure disorder or evidence of brain metastases.
• Patients with hemoptysis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AG-013736	AG-013736	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment	Up to 765 days of treatment at the data cut-off date	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.
Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment	Up to 765 days of treatment at the data cut-off date	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.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)	Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Progression-Free Survival (PFS)	Up to 1709 days of treatment	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 \[PD\]).
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)	Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
Time to Tumor Progression (TTP)	Up to 1709 days of treatment	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 \[PD\]).
Overall Survival (OS)	Up to 2002 days (maximum duration of treatment plus follow-up observation)	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.
Duration of Response	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.	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.
Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)	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)	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	Up to 1709 days of treatment plus 28-days follow-up	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.
Number of Participants Analyzed for Population Pharmacokinetics of AG-013736	Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose	Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)	Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)

Trial Locations

Locations (18)

Tokyo Women's Medical University Medical Center East; 🇯🇵 Arakawa-ku, Tokyo, Japan

Osaka University Hospital; 🇯🇵 Osaka, Japan

Akita University Hospital; 🇯🇵 Akita, Japan

National Cancer Center East Hospital; 🇯🇵 Kashiwa, Chiba, Japan

Hamamatsu University School of Medicine University Hospital; 🇯🇵 Hamamatsu-City, Shizuoka, Japan

Kinki University Hospital; 🇯🇵 Osakasayama, Osaka, Japan

Shizuoka Cancer Center; 🇯🇵 Sunto-gun, Shizuoka, Japan

Tokushima University Hospotal; 🇯🇵 Tokushima, Japan

University Hospital, Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Kochi Medical School Hospital; 🇯🇵 Nankoku-shi, Kochi-ken, Japan

Tsukuba University Hospital; 🇯🇵 Tsukuba, Ibaraki, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kyushu University Hospital, Department of Urology; 🇯🇵 Fukuoka, Japan

Iwate Medical University; 🇯🇵 Morioka, Iwate, Japan

Nihon University Itabashi Hospital; 🇯🇵 Itabashi-ku, Tokyo, Japan

National Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

National Cancer Center; 🇯🇵 Chuo-ku, Tokyo, Japan

Yamagata University Hospital; 🇯🇵 Yamagata, Japan