Trial Outcomes & Findings for Decitabine and Talazoparib in Untreated AML and R/R AML (NCT NCT02878785)

Last Updated: 2023-03-29

Results Overview

To determine the recommended Phase 2 doses of Decitabine based on numbers of participants with treatment-related adverse events, evaluated according to Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Cycle length = 28 days

Results posted on

2023-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Decitabine and Talazoparib Combo: Decitabine :10 mg/m^2: Period 1: Participants were administered 10 mg/m\^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 3: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 3: Participants were administered 20 mg/m\^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 4: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 4: Participants were administered 20 mg/m\^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.50 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 5: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 5: Participants were administered 20 mg/m\^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 0.75 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 6: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 6: Participants were administered 20 mg/m\^2 of Decitabine intravenously (IV) daily for 5 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 7: Decitabine and Talazoparib Combo:Decitabine : 20 mg/m^2;Period 7: Participants were administered 20 mg/m\^2 of Decitabine intravenously (IV) daily for 10 days every 28 days. Participants were administered 1.0 mg of Talazopzrib orally daily Days 1-28 at the same time each day.	Cohort 2:Decitabine 15 mg/m2 x 5 Days Participants were administered 15 mg/m2 x 5 days every 28 days. Participants were administered .25 mg of Talazopzrib orally daily Days 1-28 at the same time each day.
Overall Study STARTED	3	3	7	3	3	3	3
Overall Study COMPLETED	3	3	7	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Decitabine and Talazoparib Combo n=25 Participants Phase 1: Decitabine by IV daily for 5 days every 28 days. Talazoparib orally daily days 1-28. The 'outer layer' of this nested dose escalation trial will escalate the dose of the two drugs by sequentially going through dose levels 1-6 in the table found in the protocol. The standard algorithm of the 3+3 design will be applied. Decitabine: DNA methyltransferase inhibitor talazoparib: poly ADP ribose polymerase (PARP) inhibitor
Age, Categorical Cohort 1 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 1 · Between 18 and 65 years	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 1 · >=65 years	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 2 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 2 · Between 18 and 65 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 2 · >=65 years	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 3 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 3 · Between 18 and 65 years	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 3 · >=65 years	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 4 · <=18 years	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 4 · Between 18 and 65 years	2 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 4 · >=65 years	5 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 5 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 5 · Between 18 and 65 years	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 5 · >=65 years	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 6 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 6 · Between 18 and 65 years	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 6 · >=65 years	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 7 · <=18 years	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 7 · Between 18 and 65 years	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 7 · >=65 years	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 8 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 8 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 8 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 9 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 9 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 9 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 10 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 10 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 10 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 11 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 11 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 11 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 12 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 12 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 12 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 13 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 13 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 13 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 14 · <=18 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 14 · Between 18 and 65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Categorical Cohort 14 · >=65 years	0 Participants The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 1	75 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 2	75 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 3	69 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 4	73 years n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 5	63 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 6	57 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Age, Continuous Cohort 7	55 years n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 1 · Female	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 1 · Male	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 2 · Female	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 2 · Male	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 3 · Female	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 3 · Male	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 4 · Female	2 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 4 · Male	5 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 5 · Female	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 5 · Male	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 6 · Female	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 6 · Male	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 7 · Female	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Sex: Female, Male Cohort 7 · Male	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 1 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 1 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 1 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 2 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 2 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 2 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 3 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 3 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 3 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 4 · Hispanic or Latino	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 4 · Not Hispanic or Latino	7 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 4 · Unknown or Not Reported	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 5 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 5 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 5 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 6 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 6 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 6 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 7 · Hispanic or Latino	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 7 · Not Hispanic or Latino	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Ethnicity (NIH/OMB) Cohort 7 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · Black or African American	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · White	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 1 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · Black or African American	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · White	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 2 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · Black or African American	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · White	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 3 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · American Indian or Alaska Native	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · Asian	1 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · Black or African American	1 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · White	5 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · More than one race	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 4 · Unknown or Not Reported	0 Participants n=7 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · Black or African American	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · White	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 5 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · Black or African American	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · White	3 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 6 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · American Indian or Alaska Native	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · Asian	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · Black or African American	1 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · White	2 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · More than one race	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Race (NIH/OMB) Cohort 7 · Unknown or Not Reported	0 Participants n=3 Participants • The total overall enrollment was 25 patients. However, there were a total of 14 cohorts in this protocol and patients were enrolled over 7 of the 14 cohorts. Therefore, the analyzed patients in each row differs from the overall enrollment.
Region of Enrollment United States	25 participants n=25 Participants

PRIMARY outcome

Timeframe: Cycle length = 28 days

Population: 25 patients with relapsed or refractory acute myeloid leukemia

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Decitabine 10 mg/m\^2 x 5 days Talazoparib 0.25 mg	Cohort 2 n=3 Participants Decitabine 15 mg/m\^2 x 5 days Talazoparib 0.25 mg	Cohort 3 n=3 Participants Decitabine 20 mg/m\^2 x 5 days Talazoparib 0.25 mg	Cohort 4 n=7 Participants Decitabine 20 mg/m\^2 x 5 days Talazoparib 0.50 mg	Cohort 5 n=3 Participants Decitabine 20 mg/m\^2 x 5 days Talazoparib 0.75 mg	Cohort 6 n=3 Participants Decitabine 20 mg/m\^2 x 5 days Talazoparib 1.0 mg	Cohort 7 n=3 Participants Decitabine 20 mg/m\^2 x 10 days Talazoparib 1.0 mg	Cohort 8 Decitabine and Talazoparib Combo:Decitabine : 10 mg/m\^2	Cohort 9 Decitabine and Talazoparib Combo:Decitabine : 15 mg/m\^2	Cohort 10 Decitabine and Talazoparib Combo:Decitabine : 10 mg/m\^2	Cohort 11 Decitabine and Talazoparib Combo:Decitabine : 10 mg/m\^2	Cohort 12 Decitabine and Talazoparib Combo:Decitabine :15 mg/m\^2	Cohort 13 Decitabine and Talazoparib Combo:Decitabine : 15 mg/m\^2	Cohort 14 Decitabine and Talazoparib Combo:Decitabine : 15 mg/m\^2
Phase 1 - Dose Finding	10 mg/m^2	15 mg/m^2	20 mg/m^2	20 mg/m^2	20 mg/m^2	20 mg/m^2	20 mg/m^2	—	—	—	—	—	—	—

Adverse Events

Phase 1 Dose Escalation

Serious events: 25 serious events

Other events: 25 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Dose Escalation n=25 participants at risk Decitabine in combination with Talazoparib
Respiratory, thoracic and mediastinal disorders Respiratory	32.0% 8/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Respiratory, thoracic and mediastinal disorders Infection	60.0% 15/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Infections and infestations Sepsis/bacteremia	48.0% 12/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Infections and infestations Fungal infection	8.0% 2/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Infections and infestations Other infections	32.0% 8/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Infections and infestations Fever	76.0% 19/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Nervous system disorders Intracranial bleed	8.0% 2/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Cardiac disorders Pericardial tamponade	4.0% 1/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Cardiac disorders Atrial fibrillation	12.0% 3/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Gastrointestinal disorders Diarrhea	8.0% 2/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Hepatobiliary disorders Transaminitis	4.0% 1/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Hepatobiliary disorders Hyperbilirubinemia	16.0% 4/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Renal and urinary disorders Elevated creatinine	4.0% 1/25 • Number of events 25 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.

Other adverse events

Other adverse events
Measure	Phase 1 Dose Escalation n=25 participants at risk Decitabine in combination with Talazoparib
Respiratory, thoracic and mediastinal disorders Respiratory	36.0% 9/25 • Number of events 9 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Infections and infestations Other infections	20.0% 5/25 • Number of events 5 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Immune system disorders Fever	8.0% 2/25 • Number of events 2 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Cardiac disorders Atrial fibrillation	12.0% 3/25 • Number of events 3 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Gastrointestinal disorders Nausea	48.0% 12/25 • Number of events 12 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Gastrointestinal disorders Vomiting	40.0% 10/25 • Number of events 10 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Gastrointestinal disorders Diarrhea	52.0% 13/25 • Number of events 13 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Hepatobiliary disorders Transaminitis	12.0% 3/25 • Number of events 3 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.
Renal and urinary disorders Elevated creatinine	8.0% 2/25 • Number of events 2 • After the subjects signed the consent until 30 days after the subjects finished treatment, an average of 1 year. Adverse Events were not collected/monitored individually for each dose level. Arms/Groups were combined when reporting AEs and SAEs per PI discretion as only the overall toxicity data was collected and submitted and published in a medical journal.

Additional Information

Maria Baer, M.D.

University of Maryland Greenebaum Cancer Center

Phone: 410-328-8708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place