Trial Outcomes & Findings for A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED) (NCT NCT00736333)

NCT ID: NCT00736333

Last Updated: 2014-11-05

Results Overview

Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.

• Recruitment status: COMPLETED
• Target enrollment: 167 participants
• Primary outcome timeframe: Day 1 up to Week 24
• Results posted on: 2014-11-05

Participant Flow

Participant milestones

Measure	Pegylated Liposomal Doxorubicin Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Overall Study STARTED	167
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	111

Reasons for withdrawal

Measure	Pegylated Liposomal Doxorubicin Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Overall Study Did Not Receive Drug or Not Documented	7
Overall Study Data Missing	2
Overall Study Tumor Progression	75
Overall Study Toxicity	6
Overall Study Withdrawal by Subject	10
Overall Study Death	7
Overall Study Other	4

Baseline Characteristics

A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

Baseline characteristics by cohort

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Age, Continuous	62 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to Week 24

Population: Safety population (those who received at least one dose of study medication)

Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Number of Participants With Infusion Reactions (IR)	7 Participants

PRIMARY outcome

Timeframe: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin

Population: Safety population (those who received at least one dose of study medication)

Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Percent of Participants Taking Premedication for Prevention of IR Corticosteroids	96.3 Percent of participants
Percent of Participants Taking Premedication for Prevention of IR Serotonin-3 receptor antagonists (anti-emetics)	97.5 Percent of participants
Percent of Participants Taking Premedication for Prevention of IR Histamine-1 receptor blockers	15.6 Percent of participants
Percent of Participants Taking Premedication for Prevention of IR Histamine-2 receptor blockers	36.3 Percent of participants

PRIMARY outcome

Timeframe: Cycles 1 & 3 (Week 4 & Week 12)

Population: Safety population (those who received at least one dose of study medication)

Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR	0 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Safety population (those who received at least one dose of study medication)

PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)	91 Occurrences

PRIMARY outcome

Timeframe: Day 1 up to 24 weeks

Population: Safety population (those who received at least one dose of study medication)

Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Number of Times Premedications Were Given for Prevention of PPE Oral dexamethasone	66 Number of times premedication was given
Number of Times Premedications Were Given for Prevention of PPE Vitamin B6	70 Number of times premedication was given
Number of Times Premedications Were Given for Prevention of PPE Other	49 Number of times premedication was given

SECONDARY outcome

Timeframe: Day 1 up to 24 weeks

Population: Intent-to-treat (those who received at least one dose of study medication)

CR and PR were documented according to the clinical standards of each site.

Outcome measures

Measure	Pegylated Liposomal Doxorubicin n=160 Participants Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Number of Participants With Complete Response (CR) or Partial Response (PR) CR	2 Participants
Number of Participants With Complete Response (CR) or Partial Response (PR) PR	29 Participants

Adverse Events

Pegylated Liposomal Doxorubicin

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegylated Liposomal Doxorubicin n=160 participants at risk Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Blood and lymphatic system disorders Leukopenia	0.62% 1/160 • Number of events 1 The safety data were from the safety population (those who received at least one dose of study medication).
General disorders General physical health deterioration	1.2% 2/160 • Number of events 2 The safety data were from the safety population (those who received at least one dose of study medication).
Musculoskeletal and connective tissue disorders Bone pain	0.62% 1/160 • Number of events 1 The safety data were from the safety population (those who received at least one dose of study medication).
Skin and subcutaneous tissue disorders Urticaria	0.62% 1/160 • Number of events 1 The safety data were from the safety population (those who received at least one dose of study medication).

Other adverse events

Measure	Pegylated Liposomal Doxorubicin n=160 participants at risk Pegylated liposomal doxorubicin 50 mg/m\^2 given every 4 weeks for up to 6 cycles
Gastrointestinal disorders Stomatitis	5.6% 9/160 • Number of events 10 The safety data were from the safety population (those who received at least one dose of study medication).

Additional Information

Senior Vice President, Global Cllinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

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