Trial Outcomes & Findings for A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma (NCT NCT03414229)

NCT ID: NCT03414229

Last Updated: 2025-05-02

Results Overview

by RECIST 1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

by 24 weeks

Results posted on

2025-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks
Overall Study STARTED	10	5	5	10
Overall Study COMPLETED	1	0	0	0
Overall Study NOT COMPLETED	9	5	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks
Overall Study Adverse Event	1	0	2	1
Overall Study Lack of Efficacy	7	4	1	9
Overall Study Change in therapy	1	0	0	0
Overall Study Pregnancy	0	0	1	0
Overall Study Withdrawal by Subject	0	1	1	0

Baseline Characteristics

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma n=10 Participants Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma n=5 Participants Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes n=5 Participants Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other n=10 Participants Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Total n=30 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	62 years n=7 Participants	53 years n=5 Participants	45 years n=4 Participants	54 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants	29 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	30 Participants n=21 Participants

PRIMARY outcome

Timeframe: by 24 weeks

by RECIST 1.1.

Outcome measures

Outcome measures
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma n=10 Participants Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma n=5 Participants Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes n=5 Participants Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other n=10 Participants Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks
Number of Patients With Best Objective Response Rate Participants with PR	0 Participants	1 Participants	0 Participants	0 Participants
Number of Patients With Best Objective Response Rate Participants without PR	10 Participants	4 Participants	5 Participants	10 Participants

Adverse Events

UPS, Liposarcoma or Pleomorphic Liposarcoma

Serious events: 1 serious events

Other events: 10 other events

Deaths: 7 deaths

Leiomyosarcoma

Serious events: 0 serious events

Other events: 5 other events

Deaths: 4 deaths

Vascular Sarcoma Subtypes

Serious events: 0 serious events

Other events: 5 other events

Deaths: 2 deaths

Other

Serious events: 1 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma n=10 participants at risk Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma n=5 participants at risk Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes n=5 participants at risk Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other n=10 participants at risk Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks
Vascular disorders Hypertension	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Fever	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Non-cardiac chest pain	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks

Other adverse events

Other adverse events
Measure	UPS, Liposarcoma or Pleomorphic Liposarcoma n=10 participants at risk Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Leiomyosarcoma n=5 participants at risk Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Vascular Sarcoma Subtypes n=5 participants at risk Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks	Other n=10 participants at risk Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion Epacadostat: 100mg bid days 1-21 Pembrolizumab: 200mg/dose Day 1, Q 3 weeks
Gastrointestinal disorders Abdominal pain	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Alanine aminotransferase increased	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	60.0% 3/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Alkaline phosphatase increased	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	60.0% 3/5 • 24 weeks	30.0% 3/10 • 24 weeks
Skin and subcutaneous tissue disorders Alopecia	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Blood and lymphatic system disorders Anemia	30.0% 3/10 • 24 weeks	20.0% 1/5 • 24 weeks	40.0% 2/5 • 24 weeks	30.0% 3/10 • 24 weeks
Metabolism and nutrition disorders Anorexia	20.0% 2/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Psychiatric disorders Anxiety	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Aspartate aminotransferase increased	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	40.0% 2/5 • 24 weeks	30.0% 3/10 • 24 weeks
Musculoskeletal and connective tissue disorders Back pain	20.0% 2/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Eye disorders BCC L eye	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Gastrointestinal disorders Bloating	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Eye disorders Blurred vision	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Injury, poisoning and procedural complications Bruising	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Cognitive disturbance	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Psychiatric disorders Confusion	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Constipation	30.0% 3/10 • 24 weeks	60.0% 3/5 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 2/10 • 24 weeks
Nervous system disorders Cord Compression	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	30.0% 3/10 • 24 weeks
Investigations Creatinine increased	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Psychiatric disorders Depression	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Gastrointestinal disorders Diarrhea	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Dizziness	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Gastrointestinal disorders Dry mouth	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	30.0% 3/10 • 24 weeks
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Nervous system disorders Dysarthria	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	30.0% 3/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	30.0% 3/10 • 24 weeks
Gastrointestinal disorders Early Satiety	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Edema face	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Edema limbs	30.0% 3/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Elevated ALK	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Elevated ALP	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Elevated AST	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Elevated Lipase	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Injury, poisoning and procedural complications Fall	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
General disorders Fatigue	40.0% 4/10 • 24 weeks	80.0% 4/5 • 24 weeks	80.0% 4/5 • 24 weeks	50.0% 5/10 • 24 weeks
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Fever	30.0% 3/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Gastrointestinal disorders Flatulence	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Flu like symptoms	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
General disorders Gait disturbance	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Gastritis	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Nervous system disorders Headache	30.0% 3/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Hemoptysis	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Hemorrhoids	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Vascular disorders Hot flashes	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Vascular disorders Hypertension	20.0% 2/10 • 24 weeks	40.0% 2/5 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 2/10 • 24 weeks
Endocrine disorders Hyperthyroidism	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Metabolism and nutrition disorders Hypoalbuminemia	10.0% 1/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Metabolism and nutrition disorders Hypokalemia	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Metabolism and nutrition disorders Hypomagnesemia	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	40.0% 2/5 • 24 weeks	20.0% 2/10 • 24 weeks
Metabolism and nutrition disorders Hyponatremia	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Metabolism and nutrition disorders Hypophosphatemia	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Vascular disorders Hypotension	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Endocrine disorders Hypothyroidism	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Psychiatric disorders Insomnia	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Lethargy	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Lipase increased	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Localized edema	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Infections and infestations Lung infection	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Vascular disorders Lymphedema	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Melena	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Nervous system disorders Memory impairment	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Mucositis oral	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • 24 weeks	40.0% 2/5 • 24 weeks	0.00% 0/5 • 24 weeks	40.0% 4/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Nausea	10.0% 1/10 • 24 weeks	40.0% 2/5 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 2/10 • 24 weeks
Musculoskeletal and connective tissue disorders Neck pain	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Neuralgia	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
General disorders Non-cardiac chest pain	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
General disorders Pain	50.0% 5/10 • 24 weeks	60.0% 3/5 • 24 weeks	0.00% 0/5 • 24 weeks	50.0% 5/10 • 24 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Paresthesia	10.0% 1/10 • 24 weeks	40.0% 2/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Reproductive system and breast disorders Pelvic pain	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Eye disorders Periorbital	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Postnasal drip	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Skin and subcutaneous tissue disorders Rash maculo-papular	40.0% 4/10 • 24 weeks	20.0% 1/5 • 24 weeks	40.0% 2/5 • 24 weeks	20.0% 2/10 • 24 weeks
Nervous system disorders Seizure	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Skin and subcutaneous tissue disorders Sensitivity of Skin	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Serum amylase increased	20.0% 2/10 • 24 weeks	0.00% 0/5 • 24 weeks	40.0% 2/5 • 24 weeks	10.0% 1/10 • 24 weeks
Cardiac disorders Sinus tachycardia	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Skin and subcutaneous tissue disorders Skin changes to left temple	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Eye disorders Stye R eye	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Thrombocytopenia	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	20.0% 2/10 • 24 weeks
Vascular disorders Thromboembolic Event	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Infections and infestations Thrush	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Nervous system disorders Tremor	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	10.0% 1/10 • 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Infections and infestations Upper respiratory infection	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Renal and urinary disorders Urinary tract pain	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/10 • 24 weeks
Ear and labyrinth disorders Vertigo	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Gastrointestinal disorders Vomiting	0.00% 0/10 • 24 weeks	20.0% 1/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations Weight gain	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	10.0% 1/10 • 24 weeks
Investigations Weight loss	0.00% 0/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	20.0% 2/10 • 24 weeks
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Investigations White blood cell decreased	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks
Injury, poisoning and procedural complications Wound complication	10.0% 1/10 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/5 • 24 weeks	0.00% 0/10 • 24 weeks

Additional Information

Dr. Sanda D'Angelo, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place