Trial Outcomes & Findings for Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome (NCT NCT01893320)
NCT ID: NCT01893320
Last Updated: 2022-02-09
Results Overview
Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
21 days
Results posted on
2022-02-09
Participant Flow
Recruitment Period: July 2013 to June 2016
Participant milestones
| Measure |
Phase I MTD Vosaroxin
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vosaroxin + Decitabine
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
59
|
|
Overall Study
COMPLETED
|
7
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Phase I MTD Vosaroxin
n=7 Participants
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vosaroxin + Decitabine
n=59 Participants
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
Total
n=66 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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
59 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysMaximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
Outcome measures
| Measure |
Phase I MTD Vosaroxin
n=7 Participants
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vosaroxin + Decitabine
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Vosaroxin in Combination With Decitabine
|
70 Mg/m^2
|
—
|
SECONDARY outcome
Timeframe: 21 daysA Response is defined as: Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi). CR is Neutrophil count 2: 1.0 x 10\^9/L, platelet count 2: 100 x 10\^9/L and bone marrow aspirate and biopsy: S5% blasts. CRp is same as CR but with Platelets \< 100 x 10\^/L. CRi is same as CR but platelets \< 100 x 10(/L or neutrophils \< 1 x 10\^9.
Outcome measures
| Measure |
Phase I MTD Vosaroxin
n=7 Participants
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vosaroxin + Decitabine
n=59 Participants
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
|---|---|---|
|
Participants With a Response
|
7 Participants
|
42 Participants
|
Adverse Events
Phase I MTD Vosaroxin
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Vasoroxin + Decitabine
Serious events: 48 serious events
Other events: 19 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase I MTD Vosaroxin
n=7 participants at risk
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vasoroxin + Decitabine
n=59 participants at risk
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
General disorders
Back Pain
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/7 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Infections and infestations
Bone Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
5.1%
3/59 • Number of events 3 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
General disorders
Edema Face
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Enterocolitis Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
42.9%
3/7 • Number of events 8 • Up to 2 years 11 months
|
30.5%
18/59 • Number of events 23 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
General disorders
Generalized Weakness
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
0.00%
0/59 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
13.6%
8/59 • Number of events 10 • Up to 2 years 11 months
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Lung Infection
|
28.6%
2/7 • Number of events 2 • Up to 2 years 11 months
|
22.0%
13/59 • Number of events 17 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Mucositis Oral
|
28.6%
2/7 • Number of events 2 • Up to 2 years 11 months
|
6.8%
4/59 • Number of events 4 • Up to 2 years 11 months
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Cardiac disorders
Myocardial Infarction
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
0.00%
0/59 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/7 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • Up to 2 years 11 months
|
5.1%
3/59 • Number of events 3 • Up to 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
18.6%
11/59 • Number of events 12 • Up to 2 years 11 months
|
|
Infections and infestations
Skin Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
Other adverse events
| Measure |
Phase I MTD Vosaroxin
n=7 participants at risk
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
|
Vasoroxin + Decitabine
n=59 participants at risk
The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
Following the phase I portion, patients in phase II receive the following induction:
1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.
2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.
Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.
Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Investigations
Aspartate Aminotransferase Increase
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Investigations
Blood Bilirubin Increase
|
14.3%
1/7 • Number of events 1 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Nervous system disorders
Dysartharia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to 2 years 11 months
|
5.1%
3/59 • Number of events 3 • Up to 2 years 11 months
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Up to 2 years 11 months
|
3.4%
2/59 • Number of events 2 • Up to 2 years 11 months
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsness
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Up to 2 years 11 months
|
6.8%
4/59 • Number of events 5 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/7 • Up to 2 years 11 months
|
1.7%
1/59 • Number of events 1 • Up to 2 years 11 months
|
Additional Information
Naval Daver MD, Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place