Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

NCT00835978 | Completed Phase 2 Results

• 2 other identifiers: A40610462008-007786-23
• Study Type: interventional
• Target: 213
• Locations: 6 countries
• Sites: 65

Brief Summary

Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment.

Conditions

Carcinoma, Renal Cell

Keywords

axitinib or AG-013736 dose titration (increase) renal cell carcinoma; kidney cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) - Percentage of Participants With Objective Response

  ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as \>=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

  Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Secondary Outcomes (18)

• Progression-Free Survival (PFS)

  Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

• Duration of Response (DR)

  Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks

• Overall Survival (OS)

  Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

• Maximum Observed Plasma Concentration (Cmax) of Axitinib

  Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,

  C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Study Arms (3)

A

OTHER

Randomized arm

Drug: axitinib

B

OTHER

Randomized arm

Drug: axitinib

C

OTHER

Non-randomized arm

Drug: axitinib

Interventions

axitinib DRUG

axitinib 5mg BID (open-label) + axitinib dose titration (blinded)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• metastatic renal cell carcinoma (kidney cancer) with clear cell component
• no prior systemic therapy (including no prior adjuvant or neoadjuvant)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Blood Pressure \< or = 140/90mmHg

You may not qualify if:

• brain/CNS metastasis
• using more than 2 blood pressure medications

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

East Bay Medical Oncology/Hematology Medical Associates Inc.

Antioch, California, 94531, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, 94523, United States

Location

Diablo Valley Oncology and Hematology Medical Group Inc

Pleasant Hill, California, 94523, United States

Location

East Bay Medical Oncology/Hematology Medical Associates Inc

Pleasant Hill, California, 94523, United States

Location

East Bay Medical Oncology/Hematology Medical Associates Inc

San Leandro, California, 94578, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Investigational Drug Services, IUHSCC

Indianapolis, Indiana, 46202, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110-1094, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

The University Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University, James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

JamesCare in Kenny

Columbus, Ohio, 43221, United States

Location

West Chester Hospital Medical Building

West Chester, Ohio, 45069, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Texas Oncology, Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4004, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Masarykuv onkologicky ustav

Brno, CZE, 656 53, Czechia

Location

Fakultni nemocnice Olomouc Onkologicka klinika

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Krajska zdravotni, a.s. - Masarykova nemocnice V Usti nad Labem, o.z.

Ústí nad Labem, 401 13, Czechia

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover, Abt. Haematologie, Haemostaseologie & Onkologie

Hanover, 30625, Germany

Location

Eberhardt-Karls-Universitaet Tuebingen, Klinik fuer Urologie

Tübingen, 72076, Germany

Location

Klinikum Weiden Klinik fuer Urologie, Andrologie und Kinderurologie

Weiden, 92637, Germany

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Hamamatsu University School of Medicine, University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

National Cancer Center

Chuo-ku, Tokyo, 104-0045, Japan

Location

Japanese Foundation For Cancer Research Cancer Institute Hospital

Koto-ku, Tokyo, 135-8550, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

Obninsk, Kaluga Oblast, 249036, Russia

Location

State Healthcare Institution "Leningrad Regional Oncology Dispensary"

Poselok Kuzmolovskiy, Vsevolozhskiy Region, Leningradskaya Oblast, 188663, Russia

Location

FSBSI "N.N. Blokhin Russian Cancer Research Center"

Moscow, 115478, Russia

Location

FSBI"Russian Scientific Center of Roengenoradiology" of the MH of RF

Moscow, 117997, Russia

Location

Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'

Saint Petersburg, 197022, Russia

Location

Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'

Saint Petersburg, 198255, Russia

Location

GBUZ "Samara Regional Clinical Oncology Dispensary"

Samara, 443031, Russia

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (4)

• Tomita Y, Uemura H, Oya M, Shinohara N, Habuchi T, Fujii Y, Kamei Y, Umeyama Y, Bair AH, Rini BI. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study. BMC Cancer. 2019 Jan 7;19(1):17. doi: 10.1186/s12885-018-5224-6.

  PMID: 30616534 DERIVED

• de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

  PMID: 28410911 DERIVED

• Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

  PMID: 27238653 DERIVED

• Rini BI, Melichar B, Ueda T, Grunwald V, Fishman MN, Arranz JA, Bair AH, Pithavala YK, Andrews GI, Pavlov D, Kim S, Jonasch E. Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial. Lancet Oncol. 2013 Nov;14(12):1233-42. doi: 10.1016/S1470-2045(13)70464-9. Epub 2013 Oct 18.

  PMID: 24140184 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: May 26, 2014

Record last verified: 2017-04

Locations

US (31); DE (5); RU (7); JP (15); CZ (4); ES (3)