Trial Outcomes & Findings for Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer (NCT NCT02316340)
NCT ID: NCT02316340
Last Updated: 2024-01-05
Results Overview
CT Scan performed every 8 weeks to monitor progression for one year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2024-01-05
Participant Flow
Subjects were randomized to treatment for the first progression, but crossover was optional after the first progression on the initial therapy and based on physician discretion and in the best interest of the patient. For efficacy analysis: completed at least cycle 1.
Randomized, controlled trial of VOR 400 mg and HCQ 600 mg PO daily vs RGF 160 mg PO daily (3 weeks on, 1 week off), Q4weeks, in advanced CRC patients. Crossover was optional after first progression.
Participant milestones
| Measure |
Study Arm - VOR With HCQ
Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
Vorinostat: 400mg by mouth daily
Hydroxychloroquine: 600mg by mouth daily
|
Control Arm - Regorafenib
Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.
Regorafenib: 160 mg by mouth daily
|
|---|---|---|
|
First Progression
STARTED
|
20
|
22
|
|
First Progression
COMPLETED
|
17
|
21
|
|
First Progression
NOT COMPLETED
|
3
|
1
|
|
Optional Cross-over (MD Discretion)
STARTED
|
5
|
13
|
|
Optional Cross-over (MD Discretion)
COMPLETED
|
2
|
4
|
|
Optional Cross-over (MD Discretion)
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
Study Arm - VOR With HCQ
Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
Vorinostat: 400mg by mouth daily
Hydroxychloroquine: 600mg by mouth daily
|
Control Arm - Regorafenib
Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.
Regorafenib: 160 mg by mouth daily
|
|---|---|---|
|
First Progression
Clinical progression
|
2
|
1
|
|
First Progression
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Vorinostat/Hydroxychloroquine (VOR/HCQ)
n=20 Participants
Subjects randomized to the VOR/HCQ arm
|
Regorafenib (RGF)
n=22 Participants
subjects randomized to the RGF arm
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 Years
n=93 Participants
|
57.1 Years
n=4 Participants
|
58.4 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
22 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Primary location of disease
Colon
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Primary location of disease
Rectum
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Primary endpoint: median progression-free survival (mPFS) at interim analysis after at least cycle one was completed.
CT Scan performed every 8 weeks to monitor progression for one year.
Outcome measures
| Measure |
Study Arm - VOR With HCQ
n=17 Participants
Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
Vorinostat: 400mg by mouth daily
Hydroxychloroquine: 600mg by mouth daily
|
Control Arm - Regorafenib
n=21 Participants
Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.
Regorafenib: 160 mg by mouth daily
|
|---|---|---|
|
Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib
|
1.9 months
Interval 1.87 to 4.35
|
4.35 months
Interval 1.6 to
not reached
|
SECONDARY outcome
Timeframe: Baseline up to 22 monthsOverall survival was measured in months from baseline
Outcome measures
| Measure |
Study Arm - VOR With HCQ
n=20 Participants
Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
Vorinostat: 400mg by mouth daily
Hydroxychloroquine: 600mg by mouth daily
|
Control Arm - Regorafenib
n=22 Participants
Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.
Regorafenib: 160 mg by mouth daily
|
|---|---|---|
|
Median Overall Survival (mOS)
|
6.77 Months
Interval 4.0 to
The CI upper range was undefined due to insufficient number of participants with events
|
7.23 Months
Interval 4.8 to 10.8
|
Adverse Events
Study Arm - VOR With HCQ
Serious events: 0 serious events
Other events: 7 other events
Deaths: 20 deaths
Control Arm - Regorafenib
Serious events: 0 serious events
Other events: 8 other events
Deaths: 22 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Arm - VOR With HCQ
n=20 participants at risk
All study participants that enrolled and were randomized to the study intervention
|
Control Arm - Regorafenib
n=22 participants at risk
All study participants that enrolled and were randomized to the study control
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • Data collected from baseline up to 22 months.
|
0.00%
0/22 • Data collected from baseline up to 22 months.
|
|
Blood and lymphatic system disorders
Bilirubin increased
|
0.00%
0/20 • Data collected from baseline up to 22 months.
|
4.5%
1/22 • Number of events 1 • Data collected from baseline up to 22 months.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • Data collected from baseline up to 22 months.
|
0.00%
0/22 • Data collected from baseline up to 22 months.
|
|
Hepatobiliary disorders
Elevated transaminases
|
0.00%
0/20 • Data collected from baseline up to 22 months.
|
9.1%
2/22 • Number of events 2 • Data collected from baseline up to 22 months.
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
0.00%
0/20 • Data collected from baseline up to 22 months.
|
9.1%
2/22 • Number of events 2 • Data collected from baseline up to 22 months.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/20 • Data collected from baseline up to 22 months.
|
4.5%
1/22 • Number of events 1 • Data collected from baseline up to 22 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/20 • Data collected from baseline up to 22 months.
|
4.5%
1/22 • Number of events 1 • Data collected from baseline up to 22 months.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Data collected from baseline up to 22 months.
|
4.5%
1/22 • Number of events 1 • Data collected from baseline up to 22 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
3/20 • Number of events 3 • Data collected from baseline up to 22 months.
|
0.00%
0/22 • Data collected from baseline up to 22 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place