Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: axitinib; Drug: crizotinib

Detailed Description

This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 18081
    • Nemocnice Na Bulovce
  • Czech Republic
    • Olomouc, Czech Republic, Czechia, 77900
      • Fakultni nemocnice Olomouc
• France
  • Paris Cedex 13, France, 75651
    • Hopital de la Pitie Salpetriere
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem Általános Orvostudományi Kar
• Italy
  • Milano, Italy, 20133
    • Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio
  • Milano, Italy, 20133
    • Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo
• Japan
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kinki University Hospital
  • Tiba
    • Kashiwa, Tiba, Japan, 277-8577
      • National Cancer Center Hospital East
• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Russian Federation
  • Moscow, Russian Federation, 115478
    • FSBSI "N.N. Blokhin Russian Cancer Research Center"
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital / Oncology Department
• United States
  • California
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family Comprehensive Cancer Center
    • Santa Monica, California, United States, 90404
      • UCLA Hematology-Oncology-Santa Monica
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospitals
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas M.D. Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett - Providence Regional Cancer Partnership
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin - Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
• Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended
• Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease).
• Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol

Exclusion Criteria:

• Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study	Drug: axitinib; BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial; Other Names: AG-013736; Drug: crizotinib; BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.; Other Names: PF-02341066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.	Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2003
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimated): January 26, 2009

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; VEGFR inhibitor; angi-angiogenic
• Additional Relevant MeSH Terms: Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Axitinib; Crizotinib
• Other Study ID Numbers: A4061008; 2005-000051-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.