Trial Outcomes & Findings for ABEMA Alone or in COMBO With MK-6482 (NCT NCT04627064)

Last Updated: 2025-07-25

Results Overview

ORR is defined as percentage of patients with partial (PR) or complete response (CR) as best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by central review. Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

From the start of protocol treatment until disease progression or deaths. The total duration assessed was up to 3 months, as all patients either progressed, died, or withdrew from the study within that timeframe.

Results posted on

2025-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib-Arm 1 Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally	Abemaciclib and MK-6482-Arm 2 Arm 2 * Arm 2 will start enrolling only after there is experience with Arm 1 to see what abemaciclib effects are when given alone, * Dose escalation will occur following a 3+3 design. * Abemaciclib will be taken 2X daily uring 28 day study cycle * MK-6482 will be taken 1x daily during 28 day study cycle * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally MK-6482: Tablet taken orally
Overall Study STARTED	11	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib-Arm 1 Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally	Abemaciclib and MK-6482-Arm 2 Arm 2 * Arm 2 will start enrolling only after there is experience with Arm 1 to see what abemaciclib effects are when given alone, * Dose escalation will occur following a 3+3 design. * Abemaciclib will be taken 2X daily uring 28 day study cycle * MK-6482 will be taken 1x daily during 28 day study cycle * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally MK-6482: Tablet taken orally
Overall Study Progressive disease	8	0
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	0

Baseline Characteristics

ABEMA Alone or in COMBO With MK-6482

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib-Arm 1 n=11 Participants Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally	Abemaciclib and MK-6482-Arm 2 Arm 2 * Arm 2 will start enrolling only after there is experience with Arm 1 to see what abemaciclib effects are when given alone, * Dose escalation will occur following a 3+3 design. * Abemaciclib will be taken 2X daily uring 28 day study cycle * MK-6482 will be taken 1x daily during 28 day study cycle * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally MK-6482: Tablet taken orally	Total n=11 Participants Total of all reporting groups
Age, Continuous	62 Years n=99 Participants	—	62 Years n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	—	4 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	—	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants	—	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) White	11 Participants n=99 Participants	—	11 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Region of Enrollment United States	11 Participants n=99 Participants	—	11 Participants n=206 Participants
Number of Prior Lines of Systemic Therapy	4 number of therapies n=99 Participants	—	4 number of therapies n=206 Participants

PRIMARY outcome

Timeframe: From the start of protocol treatment until disease progression or deaths. The total duration assessed was up to 3 months, as all patients either progressed, died, or withdrew from the study within that timeframe.

Population: The analysis dataset is comprised of all treated participants

Outcome measures

Outcome measures
Measure	Abemaciclib-Arm 1 n=11 Participants Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally
Objective Response Rate (ORR) in Abemaciclib Arm (Arm 1)	0 Participants

PRIMARY outcome

Timeframe: From the start of protocol treatment until disease progression or death

Population: Arm 2 never opened

Percentage of patients with partial (PR) or complete response (CR) as best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by central review. Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Cycle 1 of during the combination therapy (Arm 2)

Population: Arm 2 never opened.

MTD of abemaciclib plus MK-6482, defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose limiting toxicity (DLT) in cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death, whichever occurs first.

Population: Arm 2 never opened

Toxicity will be graded and analyzed using CTCAE version 5. Treatment related AE will define as "Definitely", "Probably" or "Possibly" related to the study drugs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of complete response or partial response (whichever is first recorded) until the date of disease progression or death.

Population: No patient achieved an objective response by RECIST 1.1 criteria in Arm 1

The duration of response is defined from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the date of disease progression or death due to any cause. Participants without events reported are censored at the last disease evaluation. Response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From trial treatment start to the earlier of progression or death due to any cause. The total duration assessed was up to 3 months, as all patients either progressed, died, or withdrew from the study within that timeframe.

PFS is measured from the start of treatment until documented progression by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) or death from any cause or censored at the last disease evaluation. PFS will be estimated using the method of Kaplan-Meier with 95% confidence intervals. Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.

Outcome measures

Outcome measures
Measure	Abemaciclib-Arm 1 n=11 Participants Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally
Progression-free Survival (PFS) in Abemaciclib Arm (Arm 1)	1.8 months Interval 1.5 to 1.9

SECONDARY outcome

Timeframe: From trial treatment start to death due to any cause or date last known alive, up to 23 months

OS is measured from the start of treatment until date of death from any cause or censored at the date of last follow-up. OS will be estimated using the method of Kaplan-Meier with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Abemaciclib-Arm 1 n=11 Participants Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally
Overall Survival (OS) in Abemaciclib Arm (Arm 1)	9.1 months Interval 2.1 to 15.3

SECONDARY outcome

Timeframe: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the date of disease progression or death due to any cause.

Population: Arm 2 never opened

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From trial treatment start to the earlier of progression or death due to any cause

Population: Arm 2 never opened

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From trial treatment start to death due to any cause or date last known alive

Population: Arm 2 never opened

OS is defined the time from the start of treatment until date of death from any cause or censored at the date of last follow-up. OS will be estimated using the method of Kaplan-Meier with 95% confidence intervals.

Outcome measures

Outcome data not reported

Adverse Events

Abemaciclib-Arm 1

Serious events: 1 serious events

Other events: 11 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib-Arm 1 n=11 participants at risk Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.

Other adverse events

Other adverse events
Measure	Abemaciclib-Arm 1 n=11 participants at risk Arm 1 * Abemaciclib will be taken at a standard recommended starting dose 2X daily during 28 day study cycles and will be taken until radiographic progression, unacceptable toxicity or withdrawal. * Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter. Abemaciclib: Tablet taken orally
Gastrointestinal disorders Diarrhea	81.8% 9/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Creatinine increased	81.8% 9/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Blood and lymphatic system disorders Anemia	45.5% 5/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Nausea	45.5% 5/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Neutrophil count decreased	27.3% 3/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Anorexia	27.3% 3/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Abdominal pain	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Vomiting	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
General disorders Fatigue	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Alanine aminotransferase increased	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Weight loss	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Hyperkalemia	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Cardiac disorders Sinus bradycardia	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Dry mouth	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Fecal incontinence	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
General disorders Edema limbs	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
General disorders Pain	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Infections and infestations Urinary tract infection	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Aspartate aminotransferase increased	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Investigations Platelet count decreased	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Hypercalcemia	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Metabolism and nutrition disorders Hypomagnesemia	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Skin and subcutaneous tissue disorders Rash acneiform	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 1/11 • For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months. Adverse events (AE) are graded using Common Terminology Criteria v5.0. Serious AEs include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, resulting in significant disability/incapacity or congenital anomaly/birth defect or other significant medical events defined by protocol. All other AEs are non-SAEs.

Additional Information

Toni Choueiri, M.D

Dana-Farber Cancer Institute

Phone: 617-6325456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place