Trial Outcomes & Findings for A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer (NCT NCT00880360)

NCT ID: NCT00880360

Last Updated: 2018-03-27

Results Overview

Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2018-03-27

Participant Flow

Participant milestones

Measure	Ontak Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer

Baseline characteristics by cohort

Measure	Ontak n=19 Participants Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants
Age, Continuous	63 years STANDARD_DEVIATION 1 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	19 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.

Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.

Outcome measures

Measure	Ontak n=19 Participants Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Number of Participants Demonstrating Clinical Response	19 participants

SECONDARY outcome

Timeframe: 3 years

Population: N/A data were not collected

Determine any toxicity associated with Ontak treatment in these patients.

Outcome measures

Outcome data not reported

Adverse Events

Ontak

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tyler Curiel

University of Texas Health Science Center at San Antonio

Phone: 210-450-1000

Email: curielt@uthscsa.edu

Results disclosure agreements

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