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

Carcinoma, Renal Cell Clinical Trial

Official title:

PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569946
• Other study ID #: A4061035
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2007
• Est. completion date: October 30, 2012

Study information

• Verified date: May 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 30, 2012
• Est. primary completion date: February 26, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• AG-013736
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.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Tokyo Women's Medical University Medical Center East	Arakawa-ku	Tokyo
Japan	National Cancer Center	Chuo-ku	Tokyo
Japan	Kyushu University Hospital, Department of Urology	Fukuoka
Japan	National Kyushu Cancer Center	Fukuoka
Japan	Hamamatsu University School of Medicine University Hospital	Hamamatsu-City	Shizuoka
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	National Cancer Center East Hospital	Kashiwa	Chiba
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Iwate Medical University	Morioka	Iwate
Japan	Kochi Medical School Hospital	Nankoku-shi	Kochi-ken
Japan	Osaka University Hospital	Osaka
Japan	Kinki University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Tokushima University Hospotal	Tokushima
Japan	Tsukuba University Hospital	Tsukuba	Ibaraki
Japan	Yamagata University Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 765 days of treatment at the data cut-off date
Primary	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.	Up to 765 days of treatment at the data cut-off date
Secondary	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]).	Up to 1709 days of treatment
Secondary	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]).	Up to 1709 days of treatment
Secondary	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.	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.
Secondary	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.	Up to 2002 days (maximum duration of treatment plus follow-up observation)
Secondary	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.	Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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.	Up to 1709 days of treatment plus 28-days follow-up

External Links

•   To obtain contact information for a study center near you, click here.