Trial Outcomes & Findings for Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery (NCT NCT00227760)

NCT ID: NCT00227760

Last Updated: 2016-02-29

Results Overview

Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	Treatment (Cediranib Maleate) Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Measure	Treatment (Cediranib Maleate) n=44 Participants Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment Canada	44 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Evaluable patients

Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome measures

Measure	Treatment (Cediranib Maleate) n=39 Participants Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)	18 particip[ants

PRIMARY outcome

Timeframe: 4 weeks

Population: Evaluable patients

Partial response as assessed by RECIST criteria

Outcome measures

Measure	Treatment (Cediranib Maleate) n=39 Participants Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Objective Response, Evaluated Using RECIST	15 participants

SECONDARY outcome

Timeframe: Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years

Population: Total patients

Outcome measures

Measure	Treatment (Cediranib Maleate) n=44 Participants Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Progression Free Survival	8.9 months Interval 5.1 to 12.9

Adverse Events

Treatment (Cediranib Maleate)

Serious events: 21 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Cediranib Maleate) n=44 participants at risk Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Musculoskeletal and connective tissue disorders Back pain	4.5% 2/44 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	11.4% 5/44 • Number of events 5
Respiratory, thoracic and mediastinal disorders Hypoxia	2.3% 1/44 • Number of events 1
Vascular disorders Vascular disorder - other	2.3% 1/44 • Number of events 1
Vascular disorders Headache	6.8% 3/44 • Number of events 3
Cardiac disorders Chest pain - cardiac	4.5% 2/44 • Number of events 2
Vascular disorders Thromboembolic event	2.3% 1/44 • Number of events 1
Cardiac disorders Myocardial infarction	4.5% 2/44 • Number of events 2
Nervous system disorders Syncope	2.3% 1/44 • Number of events 1
General disorders Fatigue	2.3% 1/44 • Number of events 1
Musculoskeletal and connective tissue disorders Chest wall pain	2.3% 1/44 • Number of events 1
Nervous system disorders Seizure	2.3% 1/44 • Number of events 1

Other adverse events

Measure	Treatment (Cediranib Maleate) n=44 participants at risk Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given PO Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Infections and infestations Infection and infestations - other	4.5% 2/44 • Number of events 2
Metabolism and nutrition disorders Dehydration	4.5% 2/44 • Number of events 2

Additional Information

Dr. Srikala Sridhar

Princess Margaret Cancer Centre - University Health Network

Phone: 416-946-2249

Email: srikala.sridhar@uhn.ca

Results disclosure agreements

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

Restriction type: LTE60