Trial Outcomes & Findings for A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer (NCT NCT02661815)
NCT ID: NCT02661815
Last Updated: 2019-11-08
Results Overview
Not assessed, the MTD was not reached as the study was terminated.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
2 years
Results posted on
2019-11-08
Participant Flow
Patient were recruited in medical clinics from 03/28/2016 to 01/17/2017, the first patient was enrolled on 06/15/2016.
Participant milestones
| Measure |
Phase 1 Escalation Cohort
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 Escalation Cohort
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
Phase 1 Escalation Cohort
n=6 Participants
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
—
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data not collected as study was terminated before MTD was reached.
Not assessed, the MTD was not reached as the study was terminated.
Outcome measures
| Measure |
Phase 1 Escalation Cohort
n=6 Participants
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
|---|---|---|---|---|
|
Analysis Report on the MTD In The Dose Escalation Portion Of The Study
|
NA Participants
Data not collected as study was terminated before MTD was reached
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 13 monthsPopulation: Of the six participants, four were evaluable for response by RECIST version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease
This is now the primary outcome measure as the study was terminated prematurely.
Outcome measures
| Measure |
Phase 1 Escalation Cohort
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
n=4 Participants
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
|---|---|---|---|---|
|
Best Overall Response Measured From, Start Of Treatment To The End
Partial Response
|
—
|
—
|
—
|
2 participants
|
|
Best Overall Response Measured From, Start Of Treatment To The End
Stable Disease
|
—
|
—
|
—
|
2 participants
|
SECONDARY outcome
Timeframe: 0 yearsNo assessed TNS would only be assessed during escalation which we did not reach as the study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsNot assessed, study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsNo assessed, study was terminated.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 Expansion Cohort A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Expansion Cohort B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Expansion Cohort C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Escalation Cohort
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
Phase 1 Escalation Cohort
n=6 participants at risk
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
syncopal episode
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
Other adverse events
| Measure |
Phase 1 Expansion Cohort A
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort B
Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
Phase 1 Expansion Cohort C
Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
Bevacizumab: Please see arm/group description.
|
Phase 1 Escalation Cohort
n=6 participants at risk
Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).
Paclitaxel: Please see arm/group description.
Ricolinostat: Please see arm/group description.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
66.7%
4/6 • Number of events 4 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Gastrointestinal disorders
vomiting
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
General disorders
fatigue
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
General disorders
localized edema
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Investigations
neutrophil count decreased
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Metabolism and nutrition disorders
anorexia
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Nervous system disorders
dysgeusia
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
|
Skin and subcutaneous tissue disorders
nail discoloration
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
—
0/0 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for 1 year, 1 month.
No patients were enrolled in any of the expansion cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60