Trial Outcomes & Findings for Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer (NCT NCT02540356)
NCT ID: NCT02540356
Last Updated: 2021-01-12
Results Overview
DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria: - Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia) - Any toxicity resulted in dose delay for ≥14 days - Any grade 4 hematologic toxicity (except lymphopenia) - Grade 3 febrile neutropenia - Grade 3 thrombocytopenia associated with bleeding - Any life-threatening complication/abnormality not covered in the NCICTCAE v4.03
TERMINATED
PHASE1/PHASE2
2 participants
4 weeks
2021-01-12
Participant Flow
2 participants were enrolled for this study and 1 participant was a screen failure. Study was stopped early with only 1 participant having been dosed.
Participant milestones
| Measure |
Single-Route Arm
BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
|
Double-Route Arm
BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Single-Route Arm
BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
|
Double-Route Arm
BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
|---|---|---|
|
Overall Study
Terminated due to disease progression
|
1
|
0
|
Baseline Characteristics
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Single-Route Arm
n=1 Participants
BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
|
Double-Route Arm
BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.
DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria: - Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia) - Any toxicity resulted in dose delay for ≥14 days - Any grade 4 hematologic toxicity (except lymphopenia) - Grade 3 febrile neutropenia - Grade 3 thrombocytopenia associated with bleeding - Any life-threatening complication/abnormality not covered in the NCICTCAE v4.03
Outcome measures
| Measure |
Single-Route Arm
n=1 Participants
BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
|
Double-Route Arm
BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
|---|---|---|
|
The Occurrence of Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
PuFS is defined as the time from the last dose of Imalumab to the first therapeutic paracentesis after that, or death, whichever occurs first. Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of Imalubmab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Time to first paracentesis post-treatment is calculated as the time between the last dose of Imalumab to subsequent first therapeutic paracentesis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
The volume of ascites from the last dose of Imalumab to the first post-treatment paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, weekly during the treatment period, and every 2 weeks during the safety follow-up period, up to approximately 6 months)Population: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Ascites related symptoms: anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, heartburn
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the study period of approximately 22 monthsPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.
Outcome measures
| Measure |
Single-Route Arm
n=1 Participants
BAX69 administered weekly by intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg (Cohort S1), 10mg/kg (Cohort S2), 15mg/kg (Cohort S3)
|
Double-Route Arm
BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion as 1 of the following predefined dose regimens: 5mg/kg IV + 5mg/kg IP (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
|---|---|---|
|
Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug
SAEs
|
0 Participants
|
0 Participants
|
|
Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug
TEAEs related to study drug
|
0 Participants
|
0 Participants
|
|
Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug
TEAEs not related to study drug
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period of approximately 22 monthsPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose; and post-dose at 1.5, 4, 8, 24, and 72 hoursPopulation: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly from the baseline visit to the last week of safety follow-up (8 weeks or longer, if additional treatment will be implemented)Population: Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.
QoL will be assessed using EORTC QLQ-C30.
Outcome measures
Outcome data not reported
Adverse Events
Overall Trial
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Trial
n=1 participants at risk
Treatment with Imalumab (BAX69) over a 4-week treatment period administered weekly at one of the following dose regimens: BAX69 5mg/kg IP (intraperitoneal) (Cohort S1), 10mg/kg IP (Cohort S2), 15mg/kg IP (Cohort S3), 5mg/kg IV (intravenous) + 5mg/kg IP (intraperitoneal) (Cohort D1), 10mg/kg IV + 5mg/kg IP (Cohort D2), 10mg/kg IV + 10mg/kg IP (Cohort D3)
|
|---|---|
|
Gastrointestinal disorders
Abdominal distention (Grade 2)
|
100.0%
1/1 • Number of events 2 • From the first dose of Imalumab (BAX69) until study completion/discontinuation or 56 (±2 days) following the last dose of Imalumab.
|
|
Metabolism and nutrition disorders
Hypokalemia (Grade 1)
|
100.0%
1/1 • Number of events 1 • From the first dose of Imalumab (BAX69) until study completion/discontinuation or 56 (±2 days) following the last dose of Imalumab.
|
|
Metabolism and nutrition disorders
Hypomagnesemia (Grade 1)
|
100.0%
1/1 • Number of events 1 • From the first dose of Imalumab (BAX69) until study completion/discontinuation or 56 (±2 days) following the last dose of Imalumab.
|
|
Musculoskeletal and connective tissue disorders
Right knee pain (Grade 1)
|
100.0%
1/1 • Number of events 1 • From the first dose of Imalumab (BAX69) until study completion/discontinuation or 56 (±2 days) following the last dose of Imalumab.
|
Additional Information
Clinical Trial Registries and Results Disclosure
Baxalta, now part of Shire
Results disclosure agreements
- Principal investigator is a sponsor employee Agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until completion of the multi-center publication or twelve months following the conclusion of the study at all sites, whichever is first. Baxalta requires a review of results communication at least 90 days prior to submission. Baxalta may request an additional delay up to 60 days (e.g. for intellectual property protection).
- Publication restrictions are in place
Restriction type: OTHER