Trial Outcomes & Findings for Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer (NCT NCT00278343)

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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

74 participants

Primary outcome timeframe

After 16 weeks

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Cediranib Maleate) Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Overall Study STARTED	74
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cediranib Maleate) n=74 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	52 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: After 16 weeks

Population: Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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

Outcome measures
Measure	Treatment (Cediranib Maleate) n=74 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria Platinum sensitive participants	9 participants
Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria Platinum resistant participants	0 participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: Platinum sensitive cohort

Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate) n=47 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Time to Disease Progression Platinum Sensitive Participants	7.2 months Interval 3.9 to 9.4
Time to Disease Progression Platinum Resistant Participants	3.7 months Interval 3.4 to 4.5

SECONDARY outcome

Timeframe: From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months.

The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate) n=74 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Overall Survival (OS) (Discontinued as of 4/25/2014)	18.9 months Interval 13.5 to 31.5

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression, assessed up to 6 months

The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. 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	Treatment (Cediranib Maleate) n=74 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Progression-free Survival (PFS)	4.9 months Interval 3.9 to 7.0

SECONDARY outcome

Timeframe: Up to 4 years

Population: 1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by \> 50%. 0 confirmed PR observed in PR group.

Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by \> 50%.

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate) n=1 Participants Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Duration of Overall CA-125 Response Platinum sensitive participants	108 weeks

SECONDARY outcome

Timeframe: Up to 4 years

Population: Data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cediranib Maleate)

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cediranib Maleate) n=74 participants at risk Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Cardiac disorders Sinus tachycardia	1.4% 1/74 • Number of events 1
Metabolism and nutrition disorders Hypomagnesemia	1.4% 1/74 • Number of events 1
General disorders Death NOS	1.4% 1/74 • Number of events 1
Investigations Alkaline phosphatase increased	1.4% 1/74 • Number of events 1
Injury, poisoning and procedural complications Bruising	1.4% 1/74 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Cediranib Maleate) n=74 participants at risk Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity. cediranib maleate: Given PO laboratory biomarker analysis: Correlative studies
Cardiac disorders Myocardial infarction	2.7% 2/74 • Number of events 2
Gastrointestinal disorders Small intestinal obstruction	5.4% 4/74 • Number of events 4
Vascular disorders Thromboembolic event	2.7% 2/74 • Number of events 2
Vascular disorders Hypertension	24.3% 18/74 • Number of events 18
General disorders fatigue	17.6% 13/74 • Number of events 13
Gastrointestinal disorders diarrhea	9.5% 7/74 • Number of events 7
Nervous system disorders headache	63.5% 47/74 • Number of events 47

Additional Information

Dr. Hal Hirte

Juarvinski Cancer Centre

Phone: 905-387-9495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60