Trial Outcomes & Findings for Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX (NCT NCT00381862)

NCT ID: NCT00381862

Last Updated: 2017-06-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Up to 24 weeks
• Results posted on: 2017-06-12

Participant Flow

Participant milestones

Measure	Aprepitant and Palonosetron Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only
Overall Study STARTED	54
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

Baseline characteristics by cohort

Measure	Aprepitant and Palonosetron n=54 Participants Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 11.728 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Outcome measures

Measure	Aprepitant and Palonosetron n=54 Participants Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.	54 Participants

SECONDARY outcome

Timeframe: Duration of time that the patient is on study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of time the patient is on study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of time patient is on study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 5 days of chemotherapy

Outcome measures

Outcome data not reported

Adverse Events

Aprepitant and Palonosetron

Serious events: 29 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aprepitant and Palonosetron n=54 participants at risk Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only
Gastrointestinal disorders Abdominal Pain	5.6% 3/54 • Number of events 10
Blood and lymphatic system disorders Anemia	1.9% 1/54 • Number of events 11
Gastrointestinal disorders Bowel Obstruction	1.9% 1/54 • Number of events 2
Musculoskeletal and connective tissue disorders Compression Fracture	1.9% 1/54
Psychiatric disorders Decreased Mental Status	1.9% 1/54 • Number of events 3
General disorders Dehydration	1.9% 1/54
Gastrointestinal disorders Diarrhea	1.9% 1/54 • Number of events 26
Gastrointestinal disorders Diverticulitis	1.9% 1/54
General disorders Dizziness	1.9% 1/54
Respiratory, thoracic and mediastinal disorders Dyspnea	1.9% 1/54 • Number of events 2
Injury, poisoning and procedural complications Fall	1.9% 1/54
Gastrointestinal disorders GI Perforation	1.9% 1/54
Blood and lymphatic system disorders Hyperglycemia	1.9% 1/54 • Number of events 7
Blood and lymphatic system disorders Hypokalemia	3.7% 2/54 • Number of events 7
Infections and infestations Infections	1.9% 1/54 • Number of events 13
Gastrointestinal disorders Melena	3.7% 2/54
Blood and lymphatic system disorders Neutropenia	7.4% 4/54 • Number of events 21
Skin and subcutaneous tissue disorders Rash	3.7% 2/54 • Number of events 10
Vascular disorders Syncope	1.9% 1/54
Vascular disorders Transient Ischemic Attack (TIA)	1.9% 1/54
Vascular disorders Venous Thromboembolism (VTE)	1.9% 1/54 • Number of events 7

Other adverse events

Measure	Aprepitant and Palonosetron n=54 participants at risk Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle Palonosetron: 0.25 mg IV push on day 1 only
General disorders Fatigue	13.0% 7/54 • Number of events 24
Gastrointestinal disorders Heartburn/ Gastroesophageal Reflux Disease (GERD)	5.6% 3/54 • Number of events 10
Nervous system disorders Neuropathy-Cold Related	5.6% 3/54 • Number of events 11
Nervous system disorders Neuropathy-Peripheral/Sensory	9.3% 5/54 • Number of events 18

Additional Information

Joseph Bubalo, PharmD, BCPS, BCOP

OHSU Knight Cancer Institute

Phone: 503-494-1080

Email: bubaloj@ohsu.edu

Results disclosure agreements

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