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

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00828919

Collaborator

(none)

Enrollment

Locations

Arm

229.8

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

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 protocolThis 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 :

Mar 7, 2003

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Summary of Treatment Emergent Adverse Events (AEs) by Preferred Term Occurring In >20% Patients (All causality) [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 [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 [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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