Trial Outcomes & Findings for A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies (NCT NCT03321630)
NCT ID: NCT03321630
Last Updated: 2024-03-27
Results Overview
Overall response rate as measured by RECIST 1.1; percentage of participants who experience a best overall response of either Complete Response (CR) or Partial Response (PR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to Month 18
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Lenvatinib & Pembrolizumab
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Lenvatinib & Pembrolizumab
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Investigator Discretion
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
Baseline characteristics by cohort
| Measure |
Lenvatinib & Pembrolizumab
n=20 Participants
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 18Overall response rate as measured by RECIST 1.1; percentage of participants who experience a best overall response of either Complete Response (CR) or Partial Response (PR).
Outcome measures
| Measure |
Lenvatinib & Pembrolizumab
n=20 Participants
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Overall Response Rate
|
25 percentage of participants
Interval 8.7 to 49.0
|
PRIMARY outcome
Timeframe: Up to Month 18Estimated using Kaplan-Meier curve; interval from start of treatment to death due to any cause.
Outcome measures
| Measure |
Lenvatinib & Pembrolizumab
n=24 Participants
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Overall Survival (OS)
|
21.4 weeks
Interval 15.7 to 74.0
|
PRIMARY outcome
Timeframe: Up to Month 18Estimated using Kaplan-Meier Curves; interval between the date of start of treatment and the earlier date of objective disease progression per RECIST 1.1 criteria or death due to any cause in the absence of progression.
Outcome measures
| Measure |
Lenvatinib & Pembrolizumab
n=24 Participants
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Progression-Free Survival (PFS)
|
12.9 weeks
Interval 8.6 to 41.3
|
Adverse Events
Lenvatinib & Pembrolizumab
Serious events: 14 serious events
Other events: 18 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Lenvatinib & Pembrolizumab
n=24 participants at risk
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
54.2%
13/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Alkaline Phosphatase Increased
|
37.5%
9/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
10/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
29.2%
7/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Blood Bilirubin Increased
|
20.8%
5/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Psychiatric disorders
Confusion
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Death Nos
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Hepatobiliary disorders
Hepatic Failure
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Lung Infection
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Renal Colic
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
10/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
Other adverse events
| Measure |
Lenvatinib & Pembrolizumab
n=24 participants at risk
Lenvatinib: Lenvatinib 20 mg orally each day on days 1-7
Pembrolizumab: Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain - Right Side
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Acneiform Rash
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Psychiatric disorders
Agitation
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Alanine Aminotranferase Increased
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
4/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Alk Phosphatase Increased
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
ALT increased
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
12/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
4/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia-Knees
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Arthralgias B/L Wrists And Knees
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Ascites
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Aspartate Aminotransferase
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
8/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Ast Increased
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
B/L Edema Limbs
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Bloating
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Blood Bilirubin Increased
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Eye disorders
Blurred Vision
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Reproductive system and breast disorders
Breast Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Injury, poisoning and procedural complications
Bruising-Left Side Of Face
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Chills
|
16.7%
4/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Cold Hands
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Constipation
|
54.2%
13/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Creatinine Increased
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Cystitis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Decreased Lymphocyte Counta
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Decreased Platelet Count
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Decreased White Blood Cells
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Diarrhea
|
29.2%
7/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Dizziness
|
20.8%
5/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Dry Mouth
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Dry Skin - Hands
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Dysgeusia
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Ear and labyrinth disorders
Ear Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Edema Limbs Ankles
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Endocrine disorders
Endocrine-Other: Thyroiditis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Psychiatric disorders
Euphoria
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Fatigue
|
54.2%
13/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Fever
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain - Left
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Gait Disturbance
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Early Satiety
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gastrointestinal Disorders, Other: Mouth Sores
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gastrointestinal Disorders- Other: Abdominal Cramping
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General - Others, Blood In Mouth
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General - Others, Diaphoresis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General - Others, Hoarse Voice
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General - Others, Sweating
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Night Sweats
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Disorders And Administration Site Conditions - Other: Cold Forehead
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Disorders And Administration Site Conditions Other Gum Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other - Coccyx Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other - Dark Stool
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other - Early Satiety
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other - Gout
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other - Rhinorrhea
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
General Other: Chest Redness
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gi Other - Belching
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Gi Other Epigastric Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Gi Other: Abdominal Tenderness
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Gum Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Headache
|
29.2%
7/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Ear and labyrinth disorders
Hearing Impaired
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Hematuria
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hyperglycemia Intermittent
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Vascular disorders
Hypertension
|
25.0%
6/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypoalbminemia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
12/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
6/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
29.2%
7/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
12/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Increased Alkaline Phosphatase
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Increased Creatinine
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Inr Increased
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Psychiatric disorders
Insomnia
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Laryngitis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Left Anterior Thigh Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Left Knee Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Localized Edema
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Localized Edema - Legs/Feet
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Lower Gum Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Lymphocyte Count Decreased
|
62.5%
15/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Lymphocyte Count Increased
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other Shoulder Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
6/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
General disorders
Nausea
|
58.3%
14/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Nausea Intermittent
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Nervous System Disorders - Other, Thumb Numbness
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Neutrophil Count Decreased
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Oral - Dysesthesia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Oral Mucositis
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Oral Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain ( Right Neck Pain)
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Pain (Abdominal Pain)
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain - Left Hip
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain - Left Leg
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain - Right Foot
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain - Right Leg And Buttock
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Pain In Back Of Head
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Palmar Plantar Erythrodysesthesia Syndrome
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodyseshesia Syndrome Intolerable
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Palmer Planter Erythrodysesthesia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Palmer-Planter Erythrodysethesia Syndrome
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Partial Small Intestinal Obstruction
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Reproductive system and breast disorders
Penile Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Platelet Count Decrease Intermittent
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Platelet Count Decreased
|
41.7%
10/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Proteinuria
|
29.2%
7/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
12.5%
3/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Rash Maculo Papular
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Rash On Face
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Right Knee Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Cardiac disorders
Sinus Tachycardia
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Lesion Under Left Nipple
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation Black Discoloration Of Feet
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Skin Infection
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Skin Other Sweating
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Stomach Pain
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Cardiac disorders
Tachycardia
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Reproductive system and breast disorders
Testicular Pain
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Vascular disorders
Thromboembolic Event
|
8.3%
2/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Tremor In Hands
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Upper Respiratory Infection
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Urinary Frequency
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Urinary Retention
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Urinary Urgency
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Renal and urinary disorders
Urobilinogenuria
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Vertigo
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Nervous system disorders
Vertigo - Intermittent
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Gastrointestinal disorders
Vomiting Intermittent
|
4.2%
1/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
Weight Loss
|
20.8%
5/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
|
Investigations
White Blood Cell Count Decreased
|
50.0%
12/24 • 18 months
Systematic assessments (regulator investigator assessment at each study visit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place