Trial Outcomes & Findings for Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer (NCT NCT02579811)

Last Updated: 2023-06-29

Results Overview

The primary endpoint of progression-free survival in months (per per RECIST v1.1 criteria) will be estimated using the Kaplan-Meier method. Summary statistics will be provided along with 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 18 months

Results posted on

2023-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib n=40 Participants All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Sex/Gender, Customized Female	6 Participants n=5 Participants
Sex/Gender, Customized Male	21 Participants n=5 Participants
Sex/Gender, Customized Unknown	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 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	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: Participants who went on study

Outcome measures

Outcome measures
Measure	Axitinib n=40 Participants All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Median Progression-free Survival	8.8 months Interval 5.7 to 16.6

SECONDARY outcome

Timeframe: Up to 4 months of treatment and approximately 1 year of follow-up

Population: Participants who went on study

Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Outcome measures

Outcome measures
Measure	Axitinib n=40 Participants All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Patients With Complete Response	1 Participants

SECONDARY outcome

Timeframe: Up to 4 months of treatment and approximately 1 year of follow-up

Population: Participants who went on study

Tumor Response, defined as overall confirmed objective response, is confirmed complete response (CR) according to the RECIST 1.1 criteria. RECIST 1.1: Partial response (PR) is defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Outcome measures
Measure	Axitinib n=40 Participants All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Patients With Partial Response	17 Participants

SECONDARY outcome

Timeframe: Up to 4 months of treatment and approximately 1 year of follow-up

Population: Participants who went on study

ORR as defined by Recist V. 1.1. ORR = (CR + PR)

Outcome measures

Outcome measures
Measure	Axitinib n=40 Participants All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Objective Response Rate (ORR)	18 Participants

Adverse Events

Axitinib

Serious events: 20 serious events

Other events: 38 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Axitinib n=40 participants at risk All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
Metabolism and nutrition disorders Dehydration	15.0% 6/40 • Number of events 10 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Diarrhea	7.5% 3/40 • Number of events 5 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Cardiac disorders Hypotension	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Infections and infestations Skin infection	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Endocrine disorders Hyperkalemia	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Injury, poisoning and procedural complications Fracture	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Infections and infestations Bone infection	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Infections and infestations Fournier's gangrene	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Infections and infestations Sepsis	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Cardiac disorders Supraventricular tachycardia	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Endocrine disorders Adrenal insufficiency	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Gastric hemorrhage	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Chills	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Hypothermia	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Pain	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Metabolism and nutrition disorders Hypoglycemia	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Number of events 4 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Psychiatric disorders Confusion	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Renal and urinary disorders Hematuria	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	2.5% 1/40 • Number of events 1 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Skin and subcutaneous tissue disorders Skin ulceration	2.5% 1/40 • Number of events 2 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.

Other adverse events

Other adverse events
Measure	Axitinib n=40 participants at risk All subjects will be given axitinib on an individualized dosing schedule. Axitinib will be administered orally beginning with 5mg twice a day and can be escalated or reduced if specific grade 2 or greater toxicity develops. Axitinib will continue until progression. At progressive disease, dose escalation above current dose is allowed based on investigator discretion of clinical benefit. However, axitinib should be discontinued if a subject experiences a second RECIST progressive disease following dose escalation, patient intolerability, or at provider discretion. Axitinib: The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
General disorders Fatigue	82.5% 33/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Cardiac disorders Hypertension	75.0% 30/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Hand-foot syndrome	65.0% 26/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Metabolism and nutrition disorders Decreased appetite	60.0% 24/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Diarrhea	57.5% 23/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Dysphonia	55.0% 22/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Nausea or vomiting	50.0% 20/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Constipation	47.5% 19/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Endocrine disorders Hypothyroidism	42.5% 17/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Elevated creatinine	42.5% 17/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Musculoskeletal and connective tissue disorders Arthralgia or myalgia	32.5% 13/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Anaemia	30.0% 12/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Thrombocytopenia	17.5% 7/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Gastrointestinal disorders Mucositis	12.5% 5/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Elevated haemoglobin	10.0% 4/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Weight loss	10.0% 4/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Lymphopenia	5.0% 2/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
General disorders Headache	5.0% 2/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.
Blood and lymphatic system disorders Elevated lipase	2.5% 1/40 • Up to 4 months of treatment and approximately 30 days of additional follow-up All serious adverse events collected and all adverse events related to the study drug.

Additional Information

Dr. Moshe Ornstein

Cleveland Clinic, Case Comprehensive Cancer Center

Phone: 1-866-223-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place