Trial Outcomes & Findings for Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement (NCT NCT03724084)

NCT ID: NCT03724084

Last Updated: 2025-06-18

Results Overview

Dose escalation for phase 1b will be in the usual 3+3 fashion

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 35 days
• Results posted on: 2025-06-18

Participant Flow

Participant milestones

Measure	Cohort I (Higher and Lower Dose Pinometostat) Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement

Baseline characteristics by cohort

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 35 days

Dose escalation for phase 1b will be in the usual 3+3 fashion

Outcome measures

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Dose Limiting Toxicity (Phase Ib)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Complete Response (CR) or Complete Response With Incomplete Count Recovery (CRi) Rate	3 participants	2 participants

SECONDARY outcome

Timeframe: For up to 3 years

Will be graded and reported according to Common Terminology Criteria for Adverse Events version 5. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Outcome measures

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Number of Participants With Incidence of Adverse Events Any grade	3 participants	3 participants
Number of Participants With Incidence of Adverse Events Grade 4	3 participants	2 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data not collect and analyzed

Will be analyzed using lab evaluation of complete blood counts and differential.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to day 8

Population: Data was not collected and analyzed

Will be analyzed using lab evaluation of complete blood counts and differential.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data not collected and analyzed due to early study termination

Will be evaluated by multiparameter flow cytometry, next-generation sequencing (or both) after induction therapy among those patients who attain morphologic and cytogenetic CR. Will be calculated with the exact binomial 95% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment until progression or death, whichever occurs earliest, assessed up to 3 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=1 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Progression Free Survival	100 Days Interval 95.0 to 133.0	400 Days Interval 400.0 to 400.0

SECONDARY outcome

Timeframe: Up to 3 years

Estimated using the Kaplan-Meier method.

Outcome measures

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 Participants Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=2 Participants Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Overall Survival	326 Days Interval 181.0 to 450.0	298 Days Interval 168.0 to 428.0

Adverse Events

Cohort I (Higher and Lower Dose Pinometostat)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort II (Higher Dose Pinometostat)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 participants at risk Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 participants at risk Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Investigations White blood cell decreased	100.0% 3/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.

Other adverse events

Measure	Cohort I (Higher and Lower Dose Pinometostat) n=3 participants at risk Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.	Cohort II (Higher Dose Pinometostat) n=3 participants at risk Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 14 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Investigations Neutrophil count decreased	100.0% 3/3 • Number of events 8 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Investigations Platelet count decreased	100.0% 3/3 • Number of events 22 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	66.7% 2/3 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Investigations White blood cell decreased	100.0% 3/3 • Number of events 11 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Investigations INR increased	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Hyperphosphatemia	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Injury, poisoning and procedural complications Bruising	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	66.7% 2/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
General disorders Edema Limbs	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders cough	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Headache	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	100.0% 3/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Infections and infestations Lung Infection	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 2 years, All-Cause Mortality monitored/assessed up to 3 years.

Additional Information

Dr. James Blachly

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-7484

Email: James.Blachly@osumc.edu

Results disclosure agreements

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

Restriction type: LTE60