Trial Outcomes & Findings for Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT04753216)

NCT ID: NCT04753216

Last Updated: 2023-01-19

Results Overview

Defined as the proportion of treated subjects who experience an objective response, confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR) = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD) = Neither sufficient shrinkage to qualify

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 5 months
• Results posted on: 2023-01-19

Participant Flow

Participant milestones

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Screening - 1st Response Assessment STARTED	3
Screening - 1st Response Assessment Cycle 1	3
Screening - 1st Response Assessment Cycle 2	3
Screening - 1st Response Assessment 1st Response Assessment	2
Screening - 1st Response Assessment COMPLETED	2
Screening - 1st Response Assessment NOT COMPLETED	1
Cycle 3 - 2nd Response Assessment STARTED	2
Cycle 3 - 2nd Response Assessment Cycle 3	2
Cycle 3 - 2nd Response Assessment Cycle 4	2
Cycle 3 - 2nd Response Assessment 2nd Response Assessment	2
Cycle 3 - 2nd Response Assessment COMPLETED	1
Cycle 3 - 2nd Response Assessment NOT COMPLETED	1
Cycle 5 - 3rd Response Assessment STARTED	1
Cycle 5 - 3rd Response Assessment Cycle 5	1
Cycle 5 - 3rd Response Assessment Cycle 6	1
Cycle 5 - 3rd Response Assessment 3rd Response Assessment	0
Cycle 5 - 3rd Response Assessment COMPLETED	0
Cycle 5 - 3rd Response Assessment NOT COMPLETED	1
Survival Follow-Up STARTED	3
Survival Follow-Up COMPLETED	3
Survival Follow-Up NOT COMPLETED	0

Reasons for withdrawal

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Screening - 1st Response Assessment Adverse Event	1
Cycle 3 - 2nd Response Assessment Disease Progression	1
Cycle 5 - 3rd Response Assessment Withdrawal by Subject	1

Baseline Characteristics

Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=3 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Customized 40-49	1 Participants n=5 Participants
Age, Customized 60-69	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 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	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 months

Defined as the proportion of treated subjects who experience an objective response, confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Complete Response (CR) = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Stable Disease (SD) = Neither sufficient shrinkage to qualify

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=2 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Objective Response Rate (ORR) Partial Response	2 Participants
Objective Response Rate (ORR) Complete Response	0 Participants

SECONDARY outcome

Timeframe: Approximately 29 Weeks

Will tabulate the proportion of subjects who experience each the following as their best response to trial therapy: CR, PR, stable disease (SD), progressive disease (PD) or not evaluable (NE) per RECIST 1.1.

Complete Response (CR) = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Stable Disease (SD) = Neither sufficient shrinkage to qualify

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=2 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Overall Best Response Stable Disease	0 Participants
Overall Best Response Progressive Disease	0 Participants
Overall Best Response Partial Response	2 Participants
Overall Best Response Complete Response	0 Participants

SECONDARY outcome

Timeframe: Approximately 29 Weeks

To determine the CBR, this endpoint will calculate the proportion of treated, evaluable subjects who experience clinical benefit from trial therapy. Clinical benefit is defined as confirmed complete response (CR); confirmed partial response (PR); or stable disease (SD) for ≥ 4 months (calculated from the initiation of trial therapy on C1D1) per RECIST 1.1.16. Will tabulate the proportion of subjects who experience each of the following as their best response to trial therapy: CR, PR, stable disease (SD), progressive disease (PD) or not evaluable (NE) per RECIST 1.1. CBR data will be collected from baseline until the subject experiences disease progression initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first).

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=2 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Clinical Benefit Rate (CBR) Complete Response	0 Participants
Clinical Benefit Rate (CBR) Partial Response	2 Participants
Clinical Benefit Rate (CBR) Stable Disease	0 Participants

SECONDARY outcome

Timeframe: Approximately 29 Weeks

Population: 1 patient had PR and then progressed without a subsequent scan and is not included in number of evaluable patients

To calculate the DOR for the combination of irinotecan liposome and bevacizumab, this endpoint will be calculated as the time that elapsed between the day of first documented response to trial therapy (CR or PR, whichever is first recorded) and subsequent disease progression (taking as reference for progressive disease the smallest tumor measurements recorded on study). For DOR analysis, response is defined as complete response (CR) or partial response (PR) per RECIST 1.1; and disease progression is defined as progressive disease (PD) per RECIST 1.1.16 DOR data will be collected from the time of first response to trial therapy until the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first). If disease progression is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the DOR will be censored as the last available disease assessment.

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=1 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Duration of Response (DOR)	9.5 Weeks

SECONDARY outcome

Timeframe: Approximately 29 Weeks

To calculate the Duration of SD (CR, PR, and SD) for the combination of irinotecan liposome and bevacizumab, this endpoint will be calculated as the time that elapsed between the day of initiation of trial therapy and subsequent disease progression (taking as reference for progressive disease the smallest measurements recorded on study). Duration of SD analysis will capture subjects who achieve a best response of CR, PR, or SD, as defined per RECIST 1.1. For Duration of SD analysis, disease progression is defined as progressive disease (PD) per RECIST 1.1. Duration of SD data will be collected from baseline until the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. If disease progression is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the Duration of SD will be censored as the last available disease assessment.

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=1 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Duration of Stable Disease	14 weeks

SECONDARY outcome

Timeframe: Approximately 29 Weeks

For TTR analysis, a response to therapy is defined as a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1.

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=2 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Time to Response (TTR) Pt 01-01-101	137 days
Time to Response (TTR) Pt 01-01-102	80 days

SECONDARY outcome

Timeframe: Approximately 29 Weeks

This endpoint will calculate the progression-free survival time as the time that elapsed between the initiation of trial therapy (C1D1) and the day of first documented disease progression or death from any cause for all evaluable subjects. Per RECIST 1.1, Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=1 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Median Progression-Free Survival (PFS)	117 Days

SECONDARY outcome

Timeframe: At 16 weeks

This endpoint will be calculated based on the proportion of subjects who are alive and progression-free at 16 weeks after initiating trial therapy.

Per RECIST 1.1, Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=2 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Progression Free Survival	1 participants

SECONDARY outcome

Timeframe: Approximately 29 Weeks

Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 (NCI-CTCAE v5.0).

Outcome measures

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=3 Participants Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Number of Observed Serious and Other (Not Including Serious) Adverse Events	107 Adverse Events

Adverse Events

Treatment (Bevacizumab, Irinotecan Sucrosofate)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=3 participants at risk Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 2 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.

Other adverse events

Measure	Treatment (Bevacizumab, Irinotecan Sucrosofate) n=3 participants at risk Patients receive bevacizumab IV and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Irinotecan Sucrosofate: Given IV
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 3 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 10 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Ascites	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 2 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Blood bilirubin increased	33.3% 1/3 • Number of events 3 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Creatinine increased	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 7 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Blood and lymphatic system disorders Eosinophilia	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hyperglycemia	100.0% 3/3 • Number of events 8 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hyperphosphatemia	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 4 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 2/3 • Number of events 5 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 2 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hypokalemia	66.7% 2/3 • Number of events 7 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • Number of events 2 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
General disorders Injection site reaction	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 6 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 3 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 7 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 6 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 9 • All routine AEs, regardless of attribution or clinical significance, occurring from the time of subject registration, through 30 days after the last administration of trial therapy, must be recorded. Any event that occurs more than 30 days after the last dose of trial therapy and is attributed (possibly, probably, or definitely) to the agent(s) must also be reported as an adverse event or expedited adverse event, as applicable. This took place over a 29 week period. An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product or undergoing an experimental intervention, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product or experimental intervention.

Additional Information

Daniela Matei, MD

Northwestern University Feinberg School of Medicine

Phone: 312-472-4684

Email: daniela.matei@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place