Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    NCT00828919
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE January 23, 2009
First Posted Date  ICMJE January 26, 2009
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE March 7, 2003
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
Safety, especially thyroid gland abnormalities will be assessed using regular measurements of thyroid stimulating hormone in blood. [ Time Frame: 10 Oct 2010 ]
Change History Complete list of historical versions of study NCT00828919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2009)
Secondary safety: Serious adverse events during treatment [ Time Frame: 10 Oct 2010 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
Official Title  ICMJE CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
Brief Summary To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Treatment
Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study
Interventions:
  • Drug: axitinib
  • Drug: crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2009)
100
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00828919
Other Study ID Numbers  ICMJE A4061008
2005-000051-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP