Trial Outcomes & Findings for Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML (NCT NCT02485353)

Last Updated: 2017-09-20

Results Overview

Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

2 months

Results posted on

2017-09-20

Participant Flow

This protocol was based on enrolling 20 patients. Due to the death of 2 patients which raised safety concerns, the study was closed with 2 patients enrolled.

Participant milestones

Participant milestones
Measure	Vosaroxin and Cytarabine Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Vosaroxin and Cytarabine Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Overall Study Death	1
Overall Study Disease Progression	1

Baseline Characteristics

Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vosaroxin and Cytarabine n=2 Participants Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	72.9 years STANDARD_DEVIATION 1.03 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit

Outcome measures

Outcome measures
Measure	Vosaroxin and Cytarabine n=2 Participants Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Rate of Complete Remission	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 1 year

Population: All patients enrolled and received treatment

Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)

Outcome measures

Outcome measures
Measure	Vosaroxin and Cytarabine n=2 Participants Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Procedure or Procedure Related Adverse Events	1 Participants

Adverse Events

Vosaroxin and Cytarabine

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vosaroxin and Cytarabine n=2 participants at risk Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Infections and infestations Infections and infestations - Other	50.0% 1/2 • Up to 1 year
Infections and infestations Sepsis	50.0% 1/2 • Up to 1 year

Other adverse events

Other adverse events
Measure	Vosaroxin and Cytarabine n=2 participants at risk Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L
Gastrointestinal disorders Mucositis oral	100.0% 2/2 • Up to 1 year
General disorders Fatigue	50.0% 1/2 • Up to 1 year
General disorders Fever	100.0% 2/2 • Up to 1 year
Infections and infestations Upper respiratory infection	50.0% 1/2 • Up to 1 year
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Up to 1 year
Nervous system disorders Diziness	50.0% 1/2 • Up to 1 year
Psychiatric disorders Insomnia	50.0% 1/2 • Up to 1 year
Renal and urinary disorders Urinary retention	50.0% 1/2 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Hiccups	100.0% 2/2 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	50.0% 1/2 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Sore throat	50.0% 1/2 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Wheezing	50.0% 1/2 • Up to 1 year
Skin and subcutaneous tissue disorders Alopecia	50.0% 1/2 • Up to 1 year

Additional Information

Hamid Sayar, MD

IndianaU

Phone: 317-948-7576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place