Trial Outcomes & Findings for ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer (NCT NCT05824559)
NCT ID: NCT05824559
Last Updated: 2024-11-21
Results Overview
Progression Free Survival is measured by using laboratory testing and scans. It is measured by the length of time from first dose of study drug until observation of disease progression.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-11-21
Participant Flow
This study was open from August of 2023 to July 2024 at 7 centers in the United States. 23 subjects were enrolled. Due to business reasons this study was terminated in July of 2024, and Cohort 2 was never opened.
Participant milestones
| Measure |
ME-344 and Bevacizumab
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
ME-344 and Bevacizumab
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Progressive Disease
|
16
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
ME-344 and Bevacizumab
n=23 Participants
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All patients had relapsed metastatic colorectal cancer.
Progression Free Survival is measured by using laboratory testing and scans. It is measured by the length of time from first dose of study drug until observation of disease progression.
Outcome measures
| Measure |
ME-344 and Bevacizumab
n=23 Participants
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Progression Free Survival (PFS) Rate at 16 Weeks
|
31.8 percentage
|
SECONDARY outcome
Timeframe: 6 monthsOverall Response Rate (ORR) is defined/measured by the proportion of patients achieving complete response \[CR\] or partial response \[PR\] per RECIST v.1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
ME-344 and Bevacizumab
n=23 Participants
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
0 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
9 Participants
|
|
Overall Response Rate (ORR)
Progressive Disease
|
10 Participants
|
|
Overall Response Rate (ORR)
Not Available
|
4 Participants
|
SECONDARY outcome
Timeframe: from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 monthsThis will be measured by the number of participants with at least one treatment emergent Adverse Events (abnormal physical examination findings, abnormal vital signs, abnormal ECG QT interval and abnormal clinical laboratory results)
Outcome measures
| Measure |
ME-344 and Bevacizumab
n=23 Participants
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab
|
22 Participants
|
Adverse Events
ME-344 and Bevacizumab
Serious events: 11 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ME-344 and Bevacizumab
n=23 participants at risk
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Haematochezia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Hepatobiliary disorders
Cholecystitis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Hepatobiliary disorders
Hepatic failure
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Infections and infestations
Sepsis
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary retention
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
Other adverse events
| Measure |
ME-344 and Bevacizumab
n=23 participants at risk
ME-344 10 mg/kg (IV) Cohort 1: given on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 5 mg/kg IV Cohort 1: given on Days 1 and 15 of each 28-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Cardiac disorders
Sinus bradycardia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
34.8%
8/23 • Number of events 8 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Constipation
|
30.4%
7/23 • Number of events 7 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Diarrhoea
|
30.4%
7/23 • Number of events 7 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Number of events 5 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
5/23 • Number of events 5 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Haematochezia
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Stomatitis
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Ascites
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Colitis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Gastrointestinal disorders
Proctalgia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Fatigue
|
47.8%
11/23 • Number of events 11 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Non-cardiac chest pain
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Chills
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Asthenia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Discomfort
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Malaise
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Oedema peripheral
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Hepatobiliary disorders
Cholecystitis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Hepatobiliary disorders
Hepatic failure
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Infections and infestations
Sepsis
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Infections and infestations
Prostate infection
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Infections and infestations
Sinusitis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Stoma obstruction
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood sodium decreased
|
17.4%
4/23 • Number of events 4 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood alkaline phosphatase increased
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood bilirubin increased
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood albumin decreased
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood potassium decreased
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Urine protein/creatinine ratio increased
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Weight decreased
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Amylase increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood calcium decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood calcium increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood phosphorus decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Blood phosphorus increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Lymphocyte count decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Platelet count decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
Urine potassium increased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Investigations
White blood cell count decreased
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.4%
4/23 • Number of events 4 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Nervous system disorders
Neuropathy peripheral
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Psychiatric disorders
Anorexia nervosa
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary retention
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.7%
2/23 • Number of events 2 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.3%
1/23 • Number of events 1 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
|
Vascular disorders
Hypertension
|
13.0%
3/23 • Number of events 3 • from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER