Trial Outcomes & Findings for Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer (NCT NCT00014495)
NCT ID: NCT00014495
Last Updated: 2016-01-22
Results Overview
The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-22
Participant Flow
Participant milestones
| Measure |
Bismuth-labeled HuM195 (0.5 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (0.75 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1.25 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
20
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
19
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Bismuth-labeled HuM195 (0.5 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (0.75 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1.25 mCi/kg)
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Clinical deterioration
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Baseline characteristics by cohort
| Measure |
Bismuth-labeled HuM195 (0.5 mCi/kg)
n=3 Participants
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (0.75 mCi/kg)
n=3 Participants
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1 mCi/kg)
n=20 Participants
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1.25 mCi/kg)
n=6 Participants
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
20 participants
n=5 Participants
|
6 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.
Outcome measures
| Measure |
Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine
n=20 Participants
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
Patients are followed twice weekly for 4 weeks and then monthly for 3 months
filgrastim
cytarabine
bismuth Bi213 monoclonal antibody M195
|
|---|---|
|
Maximum Tolerated Dose
|
1 mCi/kg
|
Adverse Events
Bismuth-labeled HuM195 (0.5 mCi/kg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Bismuth-labeled HuM195 (0.75 mCi/kg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Bismuth-labeled HuM195 (1 mCi/kg)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Bismuth-labeled HuM195 (1.25 mCi/kg)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bismuth-labeled HuM195 (0.5 mCi/kg)
n=3 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (0.75 mCi/kg)
n=3 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1 mCi/kg)
n=20 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1.25 mCi/kg)
n=6 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
0.00%
0/20
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Bilirubin increased
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/20
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/20
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/20
|
33.3%
2/6 • Number of events 2
|
Other adverse events
| Measure |
Bismuth-labeled HuM195 (0.5 mCi/kg)
n=3 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (0.75 mCi/kg)
n=3 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1 mCi/kg)
n=20 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
Bismuth-labeled HuM195 (1.25 mCi/kg)
n=6 participants at risk
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.
|
|---|---|---|---|---|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
20.0%
4/20 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Derm, skin other
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.0%
2/20 • Number of events 2
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
50.0%
10/20 • Number of events 58
|
33.3%
2/6 • Number of events 5
|
|
Infections and infestations
Infection, other
|
33.3%
1/3 • Number of events 1
|
100.0%
3/3 • Number of events 5
|
70.0%
14/20 • Number of events 28
|
50.0%
3/6 • Number of events 6
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 8
|
100.0%
3/3 • Number of events 6
|
75.0%
15/20 • Number of events 106
|
100.0%
6/6 • Number of events 46
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 9
|
35.0%
7/20 • Number of events 18
|
66.7%
4/6 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
33.3%
2/6 • Number of events 4
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/20
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
66.7%
2/3 • Number of events 15
|
60.0%
12/20 • Number of events 83
|
66.7%
4/6 • Number of events 36
|
|
Investigations
Alkaline phosphatase increase
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
4/20 • Number of events 6
|
0.00%
0/6
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
4/20 • Number of events 4
|
0.00%
0/6
|
|
Investigations
Blood bilirubin increase
|
0.00%
0/3
|
0.00%
0/3
|
35.0%
7/20 • Number of events 34
|
50.0%
3/6 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
2/20 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Hemorrhage, other
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
2/20 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
2/20 • Number of events 2
|
50.0%
3/6 • Number of events 4
|
|
General disorders
Rigors, chills
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
4/20 • Number of events 4
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increase
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
2/20 • Number of events 3
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increase
|
0.00%
0/3
|
0.00%
0/3
|
30.0%
6/20 • Number of events 13
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
5.0%
1/20 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/20
|
33.3%
2/6 • Number of events 2
|
Additional Information
Dr. Martin Tallman
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place