Trial Outcomes & Findings for Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer (NCT NCT01105377)

NCT ID: NCT01105377

Last Updated: 2014-08-01

Results Overview

Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to \<1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: At 6 month evaluation
• Results posted on: 2014-08-01

Participant Flow

This study opened 4/12/2010, registered 24 participants (Cohort I), and suspended accrual due to toxicity on 9/10/2010. The study registered 23 participants (Cohort II) after re-opening 5/4/2011 with more restrictive eligibility criteria and closed 12/8/2011. The primary endpoint is evaluated using participants registered onto Cohort II.

Interim evaluation of the first 24 participants revealed more extensive disease than expected. Eligibility criteria were modified (as reflected in the Eligibility Criteria section) and registered another 23 patients (Cohort II). One patient in Cohort II cancelled prior to initiating study treatment and is not evaluable for the primary endpoint.

Participant milestones

Measure	Cohort I Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	24	23
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Cohort I Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Measure	Cohort I n=24 Participants Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II n=23 Participants Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=47 Participants Total of all reporting groups
Age, Continuous	57.0 years n=5 Participants	62.6 years n=7 Participants	58.0 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 month evaluation

Population: Analysis was performed "per protocol" using only Cohort II participants, except those deemed ineligible, cancelled, or in major treatment violation during cycle 1. One of the 23 Cohort II participants was excluded in the analysis due to cancelling before initiating treatment.

Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to <1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.

Outcome measures

Measure	Cohort I Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II n=22 Participants Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Confirmed Tumor Response	—	0 percentage of participants A 95% Confidence Interval was not estimated due to a lack of response.

SECONDARY outcome

Timeframe: From the start of treatment to the earliest of the date documenting disease progression, assessed up to 3 years

Population: Analysis for this endpoint was "per protocol" and two participants were excluded. One participant in Cohort I was ineligible and one participant in Cohort II refused to start their 1st cycle of study treatment (ie, cancelled). Therefore, 23 participants in Cohort I and 22 participants in Cohort II were analyzed for this secondary endpoint.

Time to disease progression (TTP) is defined as the time from the start of treatment to the earliest of the date documenting disease progression or most recent assessment for patients having no progression. The distribution of TTP is estimated using the method of Kaplan-Meier.

Outcome measures

Measure	Cohort I n=23 Participants Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II n=22 Participants Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Time to Progression	1.8 months Interval 1.7 to 3.7	1.9 months Interval 1.8 to 2.2

Adverse Events

Cohort I

Serious events: 12 serious events

Other events: 24 other events

Deaths: 0 deaths

Cohort II

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort I n=24 participants at risk Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II n=22 participants at risk Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Fatigue	12.5% 3/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Fever	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Abdominal infection	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Lung infection	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Cardiac disorders Cardiac disorders - Other, specify	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Cardiac disorders Chest pain - cardiac	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Colonic perforation	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Ileus	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Nausea	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Sepsis	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Skin infection	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Wound infection	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Alanine aminotransferase increased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Alkaline phosphatase increased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Aspartate aminotransferase increased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Blood bilirubin increased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Lipase increased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Lymphocyte count decreased	25.0% 6/24 • Number of events 18 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Neutrophil count decreased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Platelet count decreased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations White blood cell decreased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Acidosis	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Anorexia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hyperglycemia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypoalbuminemia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypophosphatemia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Pain in extremity	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Acute kidney injury	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Proteinuria	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Renal and urinary disorders - Other, specify	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 4/24 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Erythroderma	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.

Other adverse events

Measure	Cohort I n=24 participants at risk Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.	Cohort II n=22 participants at risk Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m\^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	79.2% 19/24 • Number of events 46 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	81.8% 18/22 • Number of events 35 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Cardiac disorders Atrial fibrillation	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Eye disorders Retinal detachment	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal distension	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal pain	29.2% 7/24 • Number of events 8 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Ascites	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Bloating	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Constipation	20.8% 5/24 • Number of events 9 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	18.2% 4/22 • Number of events 7 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Diarrhea	25.0% 6/24 • Number of events 7 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Dry mouth	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Mucositis oral	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Nausea	70.8% 17/24 • Number of events 28 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	40.9% 9/22 • Number of events 11 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Oral dysesthesia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Rectal hemorrhage	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Gastrointestinal disorders Vomiting	58.3% 14/24 • Number of events 19 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	22.7% 5/22 • Number of events 6 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Chills	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Edema limbs	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Fatigue	79.2% 19/24 • Number of events 57 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	72.7% 16/22 • Number of events 30 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Fever	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Injection site reaction	16.7% 4/24 • Number of events 10 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 5 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
General disorders Pain	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Hepatobiliary disorders Hepatic hemorrhage	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Eye infection	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Lung infection	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Sinusitis	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Soft tissue infection	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Upper respiratory infection	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Infections and infestations Urinary tract infection	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Activated partial thromboplastin time prolonged	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Alanine aminotransferase increased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Alkaline phosphatase increased	29.2% 7/24 • Number of events 8 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	18.2% 4/22 • Number of events 6 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Aspartate aminotransferase increased	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Blood bilirubin increased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations CD4 lymphocytes decreased	4.2% 1/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Creatinine increased	8.3% 2/24 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations INR increased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Lipase increased	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Lymphocyte count decreased	25.0% 6/24 • Number of events 11 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Neutrophil count decreased	4.2% 1/24 • Number of events 5 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	27.3% 6/22 • Number of events 8 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations Platelet count decreased	25.0% 6/24 • Number of events 8 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	31.8% 7/22 • Number of events 8 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Investigations White blood cell decreased	8.3% 2/24 • Number of events 15 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	45.5% 10/22 • Number of events 16 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Anorexia	33.3% 8/24 • Number of events 11 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	31.8% 7/22 • Number of events 7 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hyperglycemia	16.7% 4/24 • Number of events 6 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 5 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 6/24 • Number of events 11 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypocalcemia	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypokalemia	12.5% 3/24 • Number of events 6 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hyponatremia	16.7% 4/24 • Number of events 9 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypophosphatemia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	13.6% 3/22 • Number of events 6 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Bone pain	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Nervous system disorders Dysgeusia	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Nervous system disorders Headache	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Nervous system disorders Paresthesia	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Nervous system disorders Peripheral sensory neuropathy	4.2% 1/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Psychiatric disorders Anxiety	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Psychiatric disorders Depression	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Psychiatric disorders Insomnia	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Hematuria	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Renal and urinary disorders Proteinuria	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Reproductive system and breast disorders Uterine pain	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Alopecia	12.5% 3/24 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Dry skin	4.2% 1/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Erythema multiforme	12.5% 3/24 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	9.1% 2/22 • Number of events 3 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	16.7% 4/24 • Number of events 4 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Urticaria	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Vascular disorders Flushing	4.2% 1/24 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Vascular disorders Hypertension	4.2% 1/24 • Number of events 12 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	0.00% 0/22 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Vascular disorders Hypotension	8.3% 2/24 • Number of events 2 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/24 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.	4.5% 1/22 • Number of events 1 All participants receiving protocol treatment were evaluated for toxicity. 23 participants form Cohort I and 22 participants from Cohort II initiated treatment. Patients received 40 mg/m\^2 azacitidine subcutaneously days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10 in each 28 day cycle until disease progression or unacceptable toxicity.

Additional Information

Nilofer S. Azad, M.D.

Johns Hopkins Oncology Center

Email: nazad2@jhmi.edu

Results disclosure agreements

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

Restriction type: LTE60