Trial Outcomes & Findings for NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma (NCT NCT01649180)

Results Overview

Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Assessed every 12 weeks up to 36 months

Results posted on

2021-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib n=3 Participants Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every 12 weeks up to 36 months

Population: all participants

Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Axitinib n=3 Participants Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Progression-free Survival	16.6 months Interval 16.6 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Assessed every 12 weeks up to 36 months

Population: all participants

Best overall response was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0). Response is defined as complete response or partial response. Complete Response (CR): disappearance of all target lesions Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions

Outcome measures

Outcome measures
Measure	Axitinib n=3 Participants Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Overall Response Rate	1.00 proportion of participants Interval 0.29 to 1.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Only 3 patients were enrolled. Analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not done.

To bank biospecimens for the retrospective determination of whether baseline or changes in cytokine levels of IL-8 and VEGF-A predict response to treatment in this setting. Banking of plasma and serum is optional but strongly encouraged. Note: The assays to assess cytokine levels of IL-8 and VEGF-A were not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Only 3 patients were enrolled. Analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done.

To bank biospecimens for the retrospective determination of whether baseline single nucleotide polymorphisms (SNPs) in angiogenesis-related genes predict response to treatment (candidate gene approach). Banking of PBMC is optional but strongly encouraged. Note: The SNP genotyping analysis was not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: None of the 3 patients submitted tumor tissues so the analysis was unable to be performed.

To bank tumor tissue (formalin-fixed, paraffin-embedded tumor blocks) for retrospective examination of the molecular pathophysiologic mediators of tumorigenesis and progression such as phospho-protein expression of MAPK signaling network intermediates in endothelial cells. Banking of tumor tissue is optional but strongly encouraged. Note: None of the 3 patients submitted tumor tissues so the analysis won't be performed.

Outcome measures

Outcome data not reported

Adverse Events

Axitinib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Axitinib n=3 participants at risk Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Eye disorders Retinal vascular disorder	33.3% 1/3 • Number of events 1 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.

Other adverse events

Other adverse events
Measure	Axitinib n=3 participants at risk Axitinib will be given orally and will continue until progression of disease. Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
Vascular disorders Hypertension	100.0% 3/3 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.
General disorders Fatigue	66.7% 2/3 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	66.7% 2/3 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.
Musculoskeletal and connective tissue disorders Pain in Extremity	33.3% 1/3 • Adverse events were assessed while on treatment (up to 26 months) and for 30 days after the last dose of study drug. Adverse events were routinely assessed by the treating clinician according to the schedule above.

Additional Information

PrECOG Statistician

ECOG-ACRIN Biostatistics Center

Phone: 617-632-3633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place