Trial Outcomes & Findings for AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma (NCT NCT00243061)

NCT ID: NCT00243061

Last Updated: 2018-08-27

Results Overview

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[J Nat Cancer Inst 92(3):205-216, 2000\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Up to 6 years
• Results posted on: 2018-08-27

Participant Flow

Participant milestones

Measure	Treatment (Cediranib Maleate) Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma

Baseline characteristics by cohort

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Age, Continuous	67 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: Out of 24 patients analyzed, 0 patients had objective response of PR or CR as defined by RECIST

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Objective Tumor Response (Partial or Complete Response) According to RECIST	0 participants

PRIMARY outcome

Timeframe: Up to 6 months

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Prolonged Stable Disease According to RECIST	9 participants

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Median Survival Time	9.9 months Interval 6.8 to 20.6

SECONDARY outcome

Timeframe: At 1 year

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Survival Rate	41 percentage of participants Interval 24.0 to 64.0

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years

Population: None of the patients had Partial or complete response

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Response Duration	0 months

SECONDARY outcome

Timeframe: From the start of the treatment until the criteria for progression are met, assessed up to 6 years

Population: Only 17 of the 24 accrued patients were evaluable for response

Outcome measures

Measure	Treatment (Cediranib Maleate) n=17 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Stable Disease Duration	4.6 months Interval 3.1 to 9.1

SECONDARY outcome

Timeframe: Up to 6 years after completion of treatment

Outcome measures

Measure	Treatment (Cediranib Maleate) n=23 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0	4 highest grade

SECONDARY outcome

Timeframe: Up to 6 years

Population: 9 patients developed progressive disease

Outcome measures

Measure	Treatment (Cediranib Maleate) n=24 Participants Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Time to Disease Progression	4.1 months Interval 1.8 to 7.4

SECONDARY outcome

Timeframe: Up to 6 years

Population: data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to up to 6 years

Population: data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to up to 28 days after starting daily oral dosing

Population: data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cediranib Maleate)

Serious events: 9 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Cediranib Maleate) n=24 participants at risk Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
Vascular disorders Hypertension	12.5% 3/24
General disorders Non-cardiac chest pain	4.2% 1/24
Gastrointestinal disorders Abdominal pain	4.2% 1/24
Metabolism and nutrition disorders Dehydration	12.5% 3/24
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.2% 1/24
Gastrointestinal disorders Anorexia	4.2% 1/24
Investigations Aspartate aminotransferase increased	4.2% 1/24
Nervous system disorders Dizziness	4.2% 1/24
Infections and infestations Infections and infestations - Other, specify	4.2% 1/24
Gastrointestinal disorders Nausea	4.2% 1/24
Gastrointestinal disorders Vomiting	4.2% 1/24
Gastrointestinal disorders Diarrhea	4.2% 1/24
General disorders Fatigue	4.2% 1/24
Nervous system disorders Dysphasia	4.2% 1/24
Eye disorders Blurred vision	4.2% 1/24

Other adverse events

Measure	Treatment (Cediranib Maleate) n=24 participants at risk Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given orally laboratory biomarker analysis: Correlative studies dynamic contrast-enhanced magnetic resonance imaging: Correlative studies
General disorders Fatigue	79.2% 19/24
Gastrointestinal disorders Diarrhea	75.0% 18/24
Vascular disorders Hypertension	70.8% 17/24
Metabolism and nutrition disorders Hyperglycemia	62.5% 15/24

Additional Information

Dr. Elaine McWhirter

Juravinski Cancer Centre

Phone: 905-387-9495

Email: elaine.mcwhirter@hrcc.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60