Trial Outcomes & Findings for Ridaforolimus With Cetuximab: Adv Non-Small Cell Lung, Colorectal, Head & Neck Cancer (NCT NCT01212627)
NCT ID: NCT01212627
Last Updated: 2021-02-16
Results Overview
the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
Ridaforolimus,
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ridaforolimus With Cetuximab: Adv Non-Small Cell Lung, Colorectal, Head & Neck Cancer
Baseline characteristics by cohort
| Measure |
Ridaforolimus,
n=12 Participants
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Age, Continuous
|
57.8 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 yearthe first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day
Outcome measures
| Measure |
Ridaforolimus,
n=12 Participants
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus
|
|---|---|
|
Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab
|
20 mg/day
|
SECONDARY outcome
Timeframe: 1 yearthe first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin
Outcome measures
Outcome data not reported
Adverse Events
Ridaforolimus,
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ridaforolimus,
n=12 participants at risk
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus
|
|---|---|
|
Investigations
acute renal failure
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Anemia
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
aspiration
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
ejection fraction
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hypokalemia
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
pericardial effusion
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pleural Effusion
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
pneumonia
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Respiratory Failure
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Shortness of Breath/dyspnea
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
Other adverse events
| Measure |
Ridaforolimus,
n=12 participants at risk
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Ridaforolimus
|
|---|---|
|
Investigations
Lipase
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
LFTs
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Lymphopenia
|
41.7%
5/12 • Number of events 5 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Light headedness/dizzy
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Mucositis
|
58.3%
7/12 • Number of events 7 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
nail changes
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Nausea
|
58.3%
7/12 • Number of events 7 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Neuropathy
|
41.7%
5/12 • Number of events 5 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pain-localized
|
50.0%
6/12 • Number of events 6 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pain-general
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pain-chest
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pink eyelid
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Pleural Effusion
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Post nasal drip
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Rash
|
66.7%
8/12 • Number of events 8 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Shortness of Breath/dyspnea
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
sore throat
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Thrombocytopenia
|
33.3%
4/12 • Number of events 4 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
TSH
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Thrush
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Triglycerides
|
41.7%
5/12 • Number of events 5 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Vomitting
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
WBC
|
33.3%
4/12 • Number of events 4 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
wt loss
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
uric acid
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
acne
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Alk phos
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Anemia
|
83.3%
10/12 • Number of events 10 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Anorexia
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
change in taste
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Constipation
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
cough
|
33.3%
4/12 • Number of events 4 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Dehydration
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
despression
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Diarrhea
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Dry skin/pruritis/cracked skin
|
66.7%
8/12 • Number of events 8 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
dysphagia
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
edema
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Epistaxis
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Fatigue
|
58.3%
7/12 • Number of events 7 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Facial Hair growth
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
headache
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hiccups
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hyperbilirubinemia
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hypercholesterolemia
|
41.7%
5/12 • Number of events 5 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hypersensitivity reaction
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hypoalbuminemia
|
66.7%
8/12 • Number of events 8 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hyponatremia
|
50.0%
6/12 • Number of events 6 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hypocalcemia
|
50.0%
6/12 • Number of events 6 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
hypoglycemia
|
25.0%
3/12 • Number of events 3 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hypokalemia
|
33.3%
4/12 • Number of events 4 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hypomagnesemia
|
50.0%
6/12 • Number of events 6 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Hypotension
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Increased phosp
|
16.7%
2/12 • Number of events 2 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Increased PT/INR
|
33.3%
4/12 • Number of events 4 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
infection
|
41.7%
5/12 • Number of events 5 • Baseline, treatment, 30 days post last dose of drug
|
|
Investigations
Ingrown nail- toe
|
8.3%
1/12 • Number of events 1 • Baseline, treatment, 30 days post last dose of drug
|
Additional Information
Angela Taber, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place