Trial Outcomes & Findings for Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy (NCT NCT02732015)
NCT ID: NCT02732015
Last Updated: 2021-08-09
Results Overview
Complete response (CR) no emetic episodes and no rescue medications.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Days 1-10
Results posted on
2021-08-09
Participant Flow
A total of 37 participants were consented, 1 screen failure. protocol terminated early only part I of the protocol was completed.
Participant milestones
| Measure |
Cohort 1
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
27
|
|
Overall Study
COMPLETED
|
9
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1 - 8mg Dexamethasone
n=9 Participants
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2- 12mg Dexamethasone
n=27 Participants
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=9 Participants
|
38 years
n=27 Participants
|
38 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
20 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
16 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
27 participants
n=27 Participants
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Days 1-10Complete response (CR) no emetic episodes and no rescue medications.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2
n=26 Participants
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
|---|---|---|
|
Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose
|
0 Participants
|
5 Participants
|
Adverse Events
Cohort 1
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2
Serious events: 13 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=9 participants at risk
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2
n=26 participants at risk
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
|
|---|---|---|
|
Infections and infestations
Neutropenic Fever
|
77.8%
7/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
50.0%
13/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
50.0%
13/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
30.8%
8/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Mucositis
|
55.6%
5/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
19.2%
5/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
55.6%
5/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Skin and subcutaneous tissue disorders
Electrolytes imbalance
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
11.5%
3/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
7.7%
2/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
7.7%
2/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
7.7%
2/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Cardiac disorders
Chest pain
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
7.7%
2/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
General disorders
Uncontrolled pain
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
7.7%
2/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Cardiac disorders
Chest tightness
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
General disorders
Fatigue
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Cardiac disorders
Rapid heart rate
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Rectal tear
|
11.1%
1/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
3.8%
1/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
Other adverse events
| Measure |
Cohort 1
n=9 participants at risk
Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.
|
Cohort 2
n=26 participants at risk
Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
19.2%
5/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
General disorders
Fatigue
|
77.8%
7/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
0.00%
0/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
3/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
15.4%
4/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
23.1%
6/26 • collected from the time of informed consent to 30 days after last study drug administration, up to 10 days
|
Additional Information
Saroj Vadhan,MD-Clinical Professor, Cytokine & Supportive Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place