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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00828919
Recruitment Status : Recruiting
First Posted : January 26, 2009
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: axitinib Drug: crizotinib Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention 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)
Primary Purpose: Treatment
Official Title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
Actual Study Start Date : March 7, 2003
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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 Name: AG-013736

Drug: crizotinib
BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.
Other Name: PF-02341066




Primary Outcome Measures :
  1. Summary of Treatment Emergent Adverse Events (AEs) by Preferred Term Occurring In >20% Patients (All causality) [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  2. Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of axitinib [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

  3. Number of Participants With Treatment Emergent Adverse Events (AEs) (Treatment Related) of crizotinib [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

  4. Summary of Treatment Emergent Serious Adverse Events (SAEs) by Preferred Term (All causality) [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    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.

  5. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of axitinib [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    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.

  6. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (Treatment Related) of crizotinib [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828919


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Show Show 36 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00828919    
Other Study ID Numbers: A4061008
2005-000051-15 ( EudraCT Number )
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
VEGFR inhibitor
angi-angiogenic
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Axitinib
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action