Solid Tumors
Conditions
Keywords
VEGFR inhibitor, angi-angiogenic, tyrosine kinase inhibitor
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.
Interventions
DRUGaxitinib
BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial
DRUGcrizotinib
BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.
Sponsors
Pfizer
Study design
Allocation
NA
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | 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. |
Countries
Czechia, France, Germany, Hungary, Italy, Japan, Russia, South Korea, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
A total of 52 participants were enrolled in this study, out of which 49 were treated. Enrollment for this study was planned to be conducted into two groups: Axitinib monotherapy and Axitinib combination therapy. However, no participant enrolled in Axitinib combination therapy group.
Pre-assignment details
Participants receiving axitinib in previous trials began this study with the last dose taken in the parent study. Participants continued to access axitinib on this study as long as there was documented stable disease, responding disease, or clinical benefit at the time of prior study closure.
Participants by arm
| Arm | Count |
|---|---|
| Axitinib 2 mg Participants received Axitinib 1 micrograms (mg) twice daily orally. | 7 |
| Axitinib 3 mg Participants received Axitinib 1 mg twice daily. | 9 |
| Axitinib 5 mg Participants received Axitinib 5 mg twice daily. | 20 |
| Axitinib 7 mg Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily. | 2 |
| Other Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg. | 11 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 2 | 1 | 3 |
| Overall Study | Death | 0 | 1 | 2 | 0 | 0 |
| Overall Study | Insufficient Clinical Response | 0 | 1 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Overall Study | No longer willing to participate in study | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Objective progression or relapse | 4 | 4 | 11 | 0 | 5 |
| Overall Study | Other | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Subject refused continued treatment for reason other than adverse event | 0 | 0 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Axitinib 2 mg | Total | Other | Axitinib 7 mg | Axitinib 5 mg | Axitinib 3 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 14.7 | 60.4 Years STANDARD_DEVIATION 9 | 64.6 Years STANDARD_DEVIATION 8.6 | 68.5 Years STANDARD_DEVIATION 3.5 | 58.5 Years STANDARD_DEVIATION 4.2 | 57.1 Years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 11 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 32 Participants | 9 Participants | 2 Participants | 14 Participants | 5 Participants |
| Sex: Female, Male Female | 2 Participants | 14 Participants | 5 Participants | 1 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 35 Participants | 6 Participants | 1 Participants | 16 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 49 | 1 / 7 | 1 / 9 | 3 / 20 | 0 / 2 | 0 / 11 |
| other Total, other adverse events | 48 / 49 | 7 / 7 | 9 / 9 | 19 / 20 | 2 / 2 | 11 / 11 |
| serious Total, serious adverse events | 21 / 49 | 4 / 7 | 8 / 9 | 5 / 20 | 0 / 2 | 4 / 11 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
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.
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)
Population: Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 49 Participants |
| Overall | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 15 Participants |
| Overall | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 47 Participants |
| Overall | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 21 Participants |
| Axitinib 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 7 Participants |
| Axitinib 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 7 Participants |
| Axitinib 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 2 Participants |
| Axitinib 2 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 4 Participants |
| Axitinib 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 9 Participants |
| Axitinib 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 9 Participants |
| Axitinib 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 8 Participants |
| Axitinib 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 7 Participants |
| Axitinib 5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 18 Participants |
| Axitinib 5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 5 Participants |
| Axitinib 5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 3 Participants |
| Axitinib 5 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 20 Participants |
| Axitinib 7 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 0 Participants |
| Axitinib 7 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 2 Participants |
| Axitinib 7 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 2 Participants |
| Axitinib 7 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 0 Participants |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Serious TEAEs | 4 Participants |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | TEAEs | 11 Participants |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related Serious TEAEs | 3 Participants |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs | Treatment Related TEAEs | 11 Participants |