Continuing Access to Axitinib (A406- AG- 013736 ) 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

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fakultni nemocnice Olomouc, Olomouc, Czech Republic, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axitinib

Drug

BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial

Other names: AG-013736

Crizotinib

Drug

BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.

Other names: PF-02341066

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs

Time frame: 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)

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2023
Study completion: 2023
First posted: Jan 26, 2009
Registry last updated: Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed