Trial Outcomes & Findings for Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED) (NCT NCT00743431)

Last Updated: 2015-04-15

Results Overview

Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention.

Recruitment status

COMPLETED

Target enrollment

224 participants

Primary outcome timeframe

The observational program was conducted over a period of 2 years

Results posted on

2015-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles
Overall Study STARTED	224
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles
Overall Study Toxicity	6
Overall Study Tumor progression	56
Overall Study Withdrawal by Subject	13
Overall Study Death	9
Overall Study Reason for discontinuation not specified	29
Overall Study No documentation available	13

Baseline Characteristics

Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegylated Lyposomal Doxorubicin n=224 Participants 50 mg/m2 every 4 weeks for 6 cycles
Age, Continuous	62.4 years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Austria	224 participants n=5 Participants

PRIMARY outcome

Timeframe: The observational program was conducted over a period of 2 years

Population: Intent-to-treat (ITT) (N=214). This is also the Safety population.

Outcome measures

Outcome measures
Measure	Pegylated Lyposomal Doxorubicin n=214 Participants 50 mg/m2 every 4 weeks for 6 cycles
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Mild infusion reaction	2 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Moderate infusion reaction	5 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Severe infusion reaction	2 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) infusion reaction - severity not specified	1 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Mild PPE	37 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Moderate PPE	23 Events
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) Severe PPE	5 Events

Adverse Events

Pegylated Lyposomal Doxorubicin

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pegylated Lyposomal Doxorubicin n=214 participants at risk 50 mg/m2 every 4 weeks for 6 cycles
Blood and lymphatic system disorders Thrombocytopenia	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Gastrointestinal disorders Ascites	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Gastrointestinal disorders Constipation	1.4% 3/214 • Number of events 3 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Gastrointestinal disorders Diarrhoea	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Gastrointestinal disorders Nausea	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Gastrointestinal disorders Stomatitis	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
General disorders Asthenia	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
General disorders Death	1.4% 3/214 • Number of events 3 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
General disorders General physical health deterioraton	0.93% 2/214 • Number of events 2 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
General disorders Infusion site extravasation	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Infections and infestations Erysipelas	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Infections and infestations Pneumonia	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.93% 2/214 • Number of events 3 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Respiratory, thoracic and mediastinal disorders Pulmonary effusion	0.47% 1/214 • Number of events 1 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 3/214 • Number of events 3 Population of 214 was the Safety population as well as the Intent-to-Treat (ITT) population.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place