Trial Outcomes & Findings for A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors (NCT NCT01171924)
NCT ID: NCT01171924
Last Updated: 2016-03-01
Results Overview
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
12-15 months
Results posted on
2016-03-01
Participant Flow
Participant milestones
| Measure |
Arm A: 5 Days/Week Schedule
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
|
Arm B: 3 Days/Week Schedule
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
Baseline characteristics by cohort
| Measure |
Arm A: 5 Days/Week Schedule
n=23 Participants
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
|
Arm B: 3 Days/Week Schedule
n=23 Participants
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
65.0 years
n=7 Participants
|
63.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-15 monthsSafety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
Outcome measures
| Measure |
Arm A: 5 Days/Week Schedule
n=23 Participants
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
|
Arm B: 3 Days/Week Schedule
n=23 Participants
CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
23 participants
|
23 participants
|
Adverse Events
Arm A: 5 Days/Week
Serious events: 12 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm B: 3 Days/Week
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: 5 Days/Week
n=23 participants at risk
|
Arm B: 3 Days/Week
n=23 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23
|
0.00%
0/23
|
|
Cardiac disorders
Supraventricular tacycardia
|
4.3%
1/23
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/23
|
4.3%
1/23
|
|
General disorders
Disease progression
|
21.7%
5/23
|
13.0%
3/23
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23
|
0.00%
0/23
|
|
General disorders
Pain
|
4.3%
1/23
|
4.3%
1/23
|
|
General disorders
Pyrexia
|
4.3%
1/23
|
0.00%
0/23
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.3%
1/23
|
0.00%
0/23
|
|
Infections and infestations
Sepsis
|
4.3%
1/23
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.3%
1/23
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Blood creatinine increased
|
4.3%
1/23
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23
|
13.0%
3/23
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/23
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.3%
1/23
|
0.00%
0/23
|
|
Nervous system disorders
Syncope
|
4.3%
1/23
|
0.00%
0/23
|
|
Renal and urinary disorders
Renal failure acute
|
4.3%
1/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/23
|
4.3%
1/23
|
|
Vascular disorders
Arterial haemorrhage
|
4.3%
1/23
|
0.00%
0/23
|
Other adverse events
| Measure |
Arm A: 5 Days/Week
n=23 participants at risk
|
Arm B: 3 Days/Week
n=23 participants at risk
|
|---|---|---|
|
General disorders
Decreased Appetite
|
17.4%
4/23
|
8.7%
2/23
|
|
General disorders
Asthenia
|
8.7%
2/23
|
13.0%
3/23
|
|
Skin and subcutaneous tissue disorders
Infusion site phlebitis
|
8.7%
2/23
|
13.0%
3/23
|
|
Blood and lymphatic system disorders
ALP Increased
|
0.00%
0/23
|
17.4%
4/23
|
|
Blood and lymphatic system disorders
ALT Increased
|
0.00%
0/23
|
17.4%
4/23
|
|
Blood and lymphatic system disorders
AST Increased
|
0.00%
0/23
|
17.4%
4/23
|
|
Blood and lymphatic system disorders
BUN Increased
|
13.0%
3/23
|
4.3%
1/23
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
3/23
|
4.3%
1/23
|
|
General disorders
Pyrexia
|
17.4%
4/23
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Hypokalaemia
|
8.7%
2/23
|
4.3%
1/23
|
|
General disorders
Nausea
|
13.0%
3/23
|
39.1%
9/23
|
|
General disorders
Fatigue
|
8.7%
2/23
|
30.4%
7/23
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23
|
26.1%
6/23
|
|
Blood and lymphatic system disorders
Blood Creatinine Increased
|
21.7%
5/23
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
Anaemia
|
17.4%
4/23
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
Hypomagnesaemia
|
4.3%
1/23
|
8.7%
2/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place