Trial Outcomes & Findings for Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 (NCT NCT04070768)
NCT ID: NCT04070768
Last Updated: 2025-05-04
Results Overview
MTD was determined by testing increasing doses up to 600mg orally daily on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of drug where fewer than 33% of subjects experience a dose limiting toxicity (DLT). DLT is defined as an adverse event related (possible, probably, or definite) to Venetoclax and/or Gemtuzumab fulfilling one of the following criteria: Hematologic toxicity: treatment-related grade 3 or worse neutropenia and/or thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one (day 28) with an additional 28 days allowed for count recovery (i.e. present at day 56); Note: patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic DLT. Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity occurring within the first 56 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
42 days
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 200mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
3
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
Baseline characteristics by cohort
| Measure |
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 200mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=12 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
74 years
n=7 Participants
|
60 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint MTD followed a standard "3 + 3" design. Therefore, total participants were 3+3+6=12.
MTD was determined by testing increasing doses up to 600mg orally daily on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of drug where fewer than 33% of subjects experience a dose limiting toxicity (DLT). DLT is defined as an adverse event related (possible, probably, or definite) to Venetoclax and/or Gemtuzumab fulfilling one of the following criteria: Hematologic toxicity: treatment-related grade 3 or worse neutropenia and/or thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one (day 28) with an additional 28 days allowed for count recovery (i.e. present at day 56); Note: patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic DLT. Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity occurring within the first 56 days.
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
n=12 Participants
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Venetoclax When Administered With Gemtuzumab Ozogamicin (GO)
|
600 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint overall response rate was defined as all patients treated with at least one dose of study drug and have had their disease reevaluated.
Per International Working Group Criteria (IWGC), Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods and extramedullary disease; absolute neutrophil count \> 1.0 x 109/L(1000/μL); platelet count \> 100 x 109/L (100,000/μL); independent of red cell transfusions. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia \< 1.0 x 109/L(1000/μL) or thrombocytopenia \< 100 x 109/L (100,000/μL). Overall response rate = CR + CRi
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
n=3 Participants
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=10 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Overall Response Rate
|
0 Percentage of participants
|
33.3 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Anti-leukemic Activity Rate was defined as all patients treated with at least one dose of study drug and have had their disease reevaluated.
Per International Working Group Criteria (IWGC), Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods and extramedullary disease; absolute neutrophil count \> 1.0 x 109/L(1000/μL); platelet count \> 100 x 109/L (100,000/μL); independent of red cell transfusions. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia \< 1.0 x 109/L(1000/μL) or thrombocytopenia \< 100 x 109/L (100,000/μL). Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. Anti-leukemic activity Rate =CR+Cri+PR
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
n=3 Participants
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=10 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Anti-leukemic Activity Rate
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Relapse-free survival was defined as all patients treated with at least one dose of study drug and have achieved CR or CRi.
Per International Working Group Criteria (IWGC), Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods and extramedullary disease; absolute neutrophil count \> 1.0 x 109/L(1000/μL); platelet count \> 100 x 109/L (100,000/μL); independent of red cell transfusions. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia \< 1.0 x 109/L(1000/μL) or thrombocytopenia \< 100 x 109/L (100,000/μL). Relapse: Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease. Relapse-free survival is defined as the time from achievement of a remission until the relapse or death from any cause in patients achieving CR or CRi. Patients not known to have relapsed or died at last follow-up are censored on the date they were last examined
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=1 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=4 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Relapse-free Survival
|
—
|
3.65 Months
Not enough events occur to calculate 95% confidence interval.
|
NA Months
Not enough events occur to calculate the median and 95% confidence interval.
|
SECONDARY outcome
Timeframe: 7 monthsEvent-free Survival is defined as the time from on study to treatment failure, disease relapse, or death from any cause. Patients not known to have any of these events are censored on the date of last examined.
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
n=3 Participants
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=12 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Event-free Survival
|
1.08 Months
Interval 1.02 to
Not enough events occur to calculate upper 95% confidence interval.
|
3.84 Months
Interval 0.89 to
Not enough events occur to calculate upper 95% confidence interval.
|
1.25 Months
Interval 0.95 to
Not enough events occur to calculate upper 95% confidence interval.
|
SECONDARY outcome
Timeframe: Up to 8 monthsOverall survival is defined as the time from study entry to death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Outcome measures
| Measure |
Gemtuzumab Ozogamicin(GO) + Venetoclax
n=3 Participants
Gemtuzumab Ozogamicin(GO) + Venetoclax
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
Venetoclax: Venetoclax, 200,400, or 600mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=12 Participants
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Overall Survival (OS)
|
6.37 Months
Interval 1.22 to
The analysis is limited to participants who experience failure; there is no censoring. Therefore, the upper 95% confidence interval could not be reached.
|
6.11 Months
Interval 5.65 to
The analysis is limited to participants who experience failure; there is no censoring. Therefore, the upper 95% confidence interval could not be reached.
|
6.79 Months
Interval 1.84 to
Not enough events occur to calculate upper 95% confidence interval.
|
Adverse Events
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 200mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=12 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Metabolism and nutrition disorders
TUMOR LYSIS SYNDROME
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
33.3%
4/12 • Number of events 5 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
Other adverse events
| Measure |
Cohort 1: Venetoclax 200 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 200mg Daily Dose
|
Cohort 2: Venetoclax 400 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=3 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 400mg Daily Dose
|
Cohort 3: Venetoclax 600 mg + Gemtuzumab Ozogamicin 3 mg/m^2
n=12 participants at risk
Gemtuzumab Ozogamicin: Gemtuzumab Ozogamicin 3mg/m\^2 IV infusion will be given on days 1,4,7 on cycle 1 and days 1, 4 on cycle 2.
Venetoclax: Venetoclax 600mg Daily Dose
|
|---|---|---|---|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
33.3%
4/12 • Number of events 5 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Gastrointestinal disorders
ORAL HEMORRHAGE
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
General disorders
PAIN
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
THRUSH
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Investigations
WEIGHT GAIN
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
DIARRHEA
|
66.7%
2/3 • Number of events 2 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
Eye disorders
DRY EYE
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
General disorders
EDEMA LIMBS
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
General disorders
FATIGUE
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
33.3%
4/12 • Number of events 4 • Up to 8 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 4 • Up to 8 months
|
|
General disorders
FEVER
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 5 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
50.0%
6/12 • Number of events 8 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
41.7%
5/12 • Number of events 6 • Up to 8 months
|
|
Psychiatric disorders
INSOMNIA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
General disorders
LOCALIZED EDEMA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
66.7%
2/3 • Number of events 7 • Up to 8 months
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
33.3%
4/12 • Number of events 7 • Up to 8 months
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Investigations
PLATELET COUNT DECREASED
|
66.7%
2/3 • Number of events 3 • Up to 8 months
|
66.7%
2/3 • Number of events 3 • Up to 8 months
|
33.3%
4/12 • Number of events 9 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
100.0%
3/3 • Number of events 3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
33.3%
1/3 • Number of events 3 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
25.0%
3/12 • Number of events 4 • Up to 8 months
|
|
Gastrointestinal disorders
ANAL PAIN
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
33.3%
4/12 • Number of events 5 • Up to 8 months
|
|
Investigations
WEIGHT LOSS
|
0.00%
0/3 • Up to 8 months
|
33.3%
1/3 • Number of events 2 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 2 • Up to 8 months
|
|
Infections and infestations
BACTEREMIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
General disorders
EDEMA FACE
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
General disorders
FACIAL PAIN
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 2 • Up to 8 months
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
GASTROPARESIS
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
General disorders
GENERALIZED EDEMA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
25.0%
3/12 • Number of events 4 • Up to 8 months
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS - OTHER, SPECIFY
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATEMIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
8.3%
1/12 • Number of events 1 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
16.7%
2/12 • Number of events 3 • Up to 8 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
66.7%
2/3 • Number of events 3 • Up to 8 months
|
66.7%
2/3 • Number of events 3 • Up to 8 months
|
25.0%
3/12 • Number of events 3 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
General disorders
CHILLS
|
66.7%
2/3 • Number of events 2 • Up to 8 months
|
0.00%
0/3 • Up to 8 months
|
0.00%
0/12 • Up to 8 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
33.3%
1/3 • Number of events 1 • Up to 8 months
|
25.0%
3/12 • Number of events 5 • Up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place