Trial Outcomes & Findings for A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED) (NCT NCT00727961)

Last Updated: 2017-06-08

Results Overview

Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

4 weeks after chemotherapy completed

Results posted on

2017-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Caelyx Intravenous Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Overall Study STARTED	58
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Caelyx Intravenous Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	4
Overall Study Patient's refusal	2
Overall Study Progression	30

Baseline Characteristics

A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Age, Customized	58 participants n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after chemotherapy completed

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Number of Participants With Complete Response	0 participants

PRIMARY outcome

Timeframe: 4 weeks after chemotherapy completed

Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Number of Participants With Partial Response	5 Participants

PRIMARY outcome

Timeframe: 4 weeks after chemotherapy completed

All other subjects (except complete or partial responders and those with progression \[see prior definitions\]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Number of Participants With Stabilization	10 Participants

PRIMARY outcome

Timeframe: 4 weeks after chemotherapy completed

Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Number of Participants With Progression	6 Participants

SECONDARY outcome

Timeframe: from the beginning of study drug administration up to 4 weeks after chemotherapy completed

Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging. Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions.

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Mean Time to Positive (Partial) Treatment Response Achievement	128.0000 days Standard Deviation 50.26430

SECONDARY outcome

Timeframe: from the beginning of study drug administration up to 4 weeks after chemotherapy completed

Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Median Time to Progression	98.0 days Interval 88.8 to 107.2

SECONDARY outcome

Timeframe: from the beginning of study drug administration up to 18 months

Mean time to the occurrence of death

Outcome measures

Outcome measures
Measure	Caelyx Intravenous n=58 Participants Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles
Mean Survival Time During the Study	346.0 days Interval 272.3 to 419.7

Adverse Events

Caelyx Intravenous

Serious events: 8 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Caelyx Intravenous n=58 participants at risk
Blood and lymphatic system disorders NEUTROPENIA	1.7% 1/58 • Number of events 1
Infections and infestations PNEUMONIA	1.7% 1/58 • Number of events 1
Injury, poisoning and procedural complications ALLERGIC TRANSFUSION REACTION	5.2% 3/58 • Number of events 3
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	1.7% 1/58 • Number of events 1
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.7% 1/58 • Number of events 1
Vascular disorders VENOUS THROMBOSIS	1.7% 1/58 • Number of events 1

Other adverse events

Other adverse events
Measure	Caelyx Intravenous n=58 participants at risk
Blood and lymphatic system disorders ANAEMIA	6.9% 4/58 • Number of events 5
Blood and lymphatic system disorders LEUKOPENIA	5.2% 3/58 • Number of events 4
Blood and lymphatic system disorders NEUTROPENIA	25.9% 15/58 • Number of events 38
Gastrointestinal disorders ABDOMINAL PAIN	6.9% 4/58 • Number of events 4
Gastrointestinal disorders DIARRHOEA	19.0% 11/58 • Number of events 16
Gastrointestinal disorders FLATULENCE	5.2% 3/58 • Number of events 3
Gastrointestinal disorders NAUSEA	22.4% 13/58 • Number of events 17
Gastrointestinal disorders STOMATITIS	58.6% 34/58 • Number of events 96
Gastrointestinal disorders VOMITING	6.9% 4/58 • Number of events 4
General disorders ASTHENIA	5.2% 3/58 • Number of events 3
General disorders FATIGUE	46.6% 27/58 • Number of events 45
General disorders PYREXIA	5.2% 3/58 • Number of events 5
Investigations BODY TEMPERATURE INCREASED	8.6% 5/58 • Number of events 5
Nervous system disorders HYPOAESTHESIA	5.2% 3/58 • Number of events 5
Skin and subcutaneous tissue disorders DRY SKIN	10.3% 6/58 • Number of events 9
Skin and subcutaneous tissue disorders ERYTHEMA	6.9% 4/58 • Number of events 4
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	56.9% 33/58 • Number of events 92
Skin and subcutaneous tissue disorders RASH	22.4% 13/58 • Number of events 26
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	5.2% 3/58 • Number of events 3

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