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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00569946

Purpose

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

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: AG-013736	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Axitinib

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Phase 2 Study Of AG-013736 As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC) [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma concentration of s-VEGFR1, s-VEGFR2, s-VEGFR3, s-KIT and VEGF [ Time Frame: End of study ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: End of study ] [ Designated as safety issue: No ]
Plasma PK of AG-013736 [ Time Frame: End of study ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: End of study ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: End of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: At least 3 years ] [ Designated as safety issue: No ]
Adverse Events and abnormal change of laboratory test date [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	63
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AG-013736: Experimental	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.

Eligibility

Criteria

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569946

Locations

Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Akita, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Tokushima, Japan
Pfizer Investigational Site
Yamagata, Japan
Japan, Chiba
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Japan, Hokkaido
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Japan, Ibaraki
Pfizer Investigational Site
Tsukuba, Ibaraki, Japan
Japan, Iwate
Pfizer Investigational Site
Morioka, Iwate, Japan
Japan, Kochi-ken
Pfizer Investigational Site
Nankoku-shi, Kochi-ken, Japan
Japan, Osaka
Pfizer Investigational Site
Osakasayama, Osaka, Japan
Japan, Shizuoka
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Japan, Tokyo
Pfizer Investigational Site
Arakawa-ku, Tokyo, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Itabashi-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061035
Study First Received:	December 7, 2007
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00569946 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

AG-013736, RCC, Phase 2

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009