Clinical trial NCT00569946: Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
Official title: PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: AG-013736
RCC
Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


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 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.

Primary outcomes:
measure: Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment
timeFrame: Up to 765 days of treatment at the data cut-off date
measure: Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment
timeFrame: Up to 765 days of treatment at the data cut-off date
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1709 days of treatment
measure: Time to Tumor Progression (TTP)
timeFrame: Up to 1709 days of treatment
measure: Duration of Response
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: Up to 2002 days (maximum duration of treatment plus follow-up observation)
measure: Number of Participants Analyzed for Population Pharmacokinetics of AG-013736
timeFrame: Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)
timeFrame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)
timeFrame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)
timeFrame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
measure: Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)
timeFrame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
measure: Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)
timeFrame: Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)
measure: Number of Participants With Adverse Events
timeFrame: Up to 1709 days of treatment plus 28-days follow-up
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center East Hospital
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University
state: Iwate
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi-ken
city: Osakasayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Hamamatsu-City
country: Japan
facility: Hamamatsu University School of Medicine University Hospital
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Arakawa-ku
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital, Department of Urology
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospotal
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Schindler E, Amantea MA, Karlsson MO, Friberg LE. A Pharmacometric Framework for Axitinib Exposure, Efficacy, and Safety in Metastatic Renal Cell Carcinoma Patients. CPT Pharmacometrics Syst Pharmacol. 2017 Jun;6(6):373-382. doi: 10.1002/psp4.12193. Epub 2017 May 26.
citation: Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma. Cancer Sci. 2014 Dec;105(12):1576-83. doi: 10.1111/cas.12546. Epub 2014 Nov 25.
citation: Tomita Y, Uemura H, Fujimoto H, Kanayama HO, Shinohara N, Nakazawa H, Imai K, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell Carcinoma. Eur J Cancer. 2011 Nov;47(17):2592-602. doi: 10.1016/j.ejca.2011.07.014. Epub 2011 Aug 31.