Trial Outcomes & Findings for Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma (NCT NCT01321437)

Last Updated: 2021-01-20

Results Overview

The response rate (CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) will be provided with an exact 95% 2-sided confidence interval calculated using a method based on the F distribution.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2021-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Age, Customized Median Age	63 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	9 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	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Overall Response Rate, Defined as the Percentage of Patients With a Confirmed Clinical Response (CR) or Partial Response (PR)	3 Participants

SECONDARY outcome

Timeframe: From the date of first dose of axitinib to the first date that criteria for progression were met or the patient died, assessed up to 1 year

An estimate of the PFS curve from the Kaplan-Meier method will be presented. Median event time and a 2-sided 95% confidence interval for the median will be provided.

Outcome measures

Outcome measures
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Progression-free Survival (PFS)	4 months Interval 2.8 to 8.5

SECONDARY outcome

Timeframe: From the day the criteria for PR or CR were met to the first day criteria for progression occurred, assessed up to 1 year

Estimates of duration of overall response from the Kaplan-Meier method will be presented. Median event time (if appropriate) and a 2-sided 95% confidence interval for the median will be provided. The number of CR and PR patients may be small and thereby limit use of the Kaplan-Meier method to provide reliable information. In this case, descriptive statistics or listings will be provided.

Outcome measures

Outcome measures
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Duration of Overall Response	8 months Interval 3.5 to 13.3

SECONDARY outcome

Timeframe: From the day of first dose of axitinib to the day of death, until at least one year after the initial dose for the last treated patient.

An estimate of the survival time curve from the Kaplan-Meier method will be presented. Median event time and a 2-sided 95% confidence interval for the median will be provided.

Outcome measures

Outcome measures
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Survival	59 months Interval 29.6 to 67.5

SECONDARY outcome

Timeframe: Up to at least 28 days after the last dose of study drug, on average of 1 year.

Population: Please refer to the Adverse Event tables for specifics.

Will be displayed by body system and preferred term according to Medical Dictionary for Regulatory Activities (MedDRA) terminology. Detailed information collected for each AE will include: description of the event, duration, whether the AE was serious, intensity, relationship to study drug, action taken, and clinical outcome. Intensity (severity) of the AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Axitinib n=11 Participants Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Frequencies of Patients Experiencing at Least One Adverse Event (AE)	11 Participants

Adverse Events

Axitinib

Serious events: 1 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Axitinib n=11 participants at risk Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Blood and lymphatic system disorders Hypertension	9.1% 1/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.

Other adverse events

Other adverse events
Measure	Axitinib n=11 participants at risk Patients receive axitinib PO BID on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 14-21 days after completion of treatment. Beginning 28-56 days after surgery, patients receive axitinib PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity therapeutic conventional surgery: Undergo surgery laboratory biomarker analysis: Correlative studies Axitinib: Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events. pharmacological study: Correlative studies
Blood and lymphatic system disorders Hypertension	45.5% 5/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
Renal and urinary disorders Proteinuria	9.1% 1/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Fatigue	45.5% 5/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
Renal and urinary disorders Diarrhea	27.3% 3/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
Gastrointestinal disorders Mucositis	27.3% 3/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Hoarseness	27.3% 3/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Nausea	27.3% 3/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Weight Loss	18.2% 2/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Loss of Taste	18.2% 2/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
General disorders Pain in Limb	18.2% 2/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.
Blood and lymphatic system disorders Hypothyroidism	18.2% 2/11 • Adverse events are collected from the time the patient signs the consent from until 28 days after the last administration of the investigational product, on average of 1 year.

Additional Information

UC Irvine Health / Chao Family Comprehensive Cancer Center

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place