Trial Outcomes & Findings for A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer (NCT NCT03042702)
NCT ID: NCT03042702
Last Updated: 2018-12-27
Results Overview
Reporting of Adverse Events, and severity of adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
6 Weeks
Results posted on
2018-12-27
Participant Flow
No participants were enrolled in the "Kevetrin 350 mg/m2 IV"/"Cohort 2" Arm/Group.
Participant milestones
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Age, Customized
54 years old
|
1 Participants
n=5 Participants
|
|
Age, Customized
71 years old
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksReporting of Adverse Events, and severity of adverse events
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
TEAE Yes
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
TEAE No
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 WeeksPopulation: All
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Number of Participants With Changes in Biomarkers
Observed biomarker changes
|
2 Participants
|
|
Number of Participants With Changes in Biomarkers
No observed biomarker changes
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 WeeksNumber of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Number of Participants by RECIST Tumor Response Category
Complete response
|
0 Participants
|
|
Number of Participants by RECIST Tumor Response Category
Stable disease
|
2 Participants
|
|
Number of Participants by RECIST Tumor Response Category
Partial response
|
0 Participants
|
|
Number of Participants by RECIST Tumor Response Category
Progressive disease
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hourMeasurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Subject 002-001 Cmax Day 1
|
1820 ng/mL
|
|
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Subject 002-001 Cmax Day 5
|
1840 ng/mL
|
|
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Subject 002-002 Cmax Day 1
|
2410 ng/mL
|
|
Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5
Subject 002-002 Cmax Day 5
|
2450 ng/mL
|
SECONDARY outcome
Timeframe: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hourMeasurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Subject 002-001 Tmax Day 1
|
2.97 hours
|
|
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Subject 002-001 Tmax Day 5
|
2.97 hours
|
|
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Subject 002-002 Tmax Day 1
|
2.97 hours
|
|
Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5
Subject 002-002 Tmax Day 5
|
1.97 hours
|
SECONDARY outcome
Timeframe: Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hourMeasurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.
Outcome measures
| Measure |
Kevetrin 250 mg/m2 IV/Cohort 1
n=2 Participants
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Subject 002-001 AUCt Day 1
|
6851 hours*ng/mL
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Subject 002-001 AUCt Day 5
|
6531 hours*ng/mL
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Subject 002-002 AUCt Day 1
|
8141 hours*ng/mL
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5
Subject 002-002 AUCt Day 5
|
8385 hours*ng/mL
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=2 participants at risk
Kevetrin 250 mg/m2 IV per dose every other day (q.o.d.)/ 3 doses per week (750 mg/m2 per week), for 3 weeks (single cycle; total 9 doses) Follow-up For 3 weeks after Kevetrin treatment ends
Kevetrin: Kevetrin dose to associated cohort
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
General disorders
Chest pain
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Gastrointestinal disorders
Fatigue
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Psychiatric disorders
Agitation
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • AEs were collected from Screening thru End of Study. approximately 6 weeks
|
Additional Information
Arthur P. Bertolino MD, PhD, MBA
Innovation Pharmaceuticals
Phone: 9789214125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60