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

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

Detailed Description
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: axitinib
* Drug: crizotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Interventional Model Description: This is a continuing access, open label study for patients to receive monotherapy or combination therapy based on previous treatment received in parent protocol
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Treatment Emergent Adverse Events (AEs) by Preferred Term Occurring In >20% Patients (All causality) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of axitinib | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of crizotinib | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Summary of Treatment Emergent Serious Adverse Events (SAEs) by Preferred Term (All causality) | 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. | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of axitinib | 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. | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of crizotinib | 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. | Baseline (Day 0) up to 28 days after last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VEGFR inhibitor, angi-angiogenic, tyrosine kinase inhibitor