Trial Outcomes & Findings for Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens (NCT NCT04989816)

NCT ID: NCT04989816

Last Updated: 2024-11-21

Results Overview

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months

Results posted on

2024-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	T-DXd Arm T-DXd monotherapy
Overall Study STARTED	95
Overall Study Received Treatment	95
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Reasons for withdrawal
Measure	T-DXd Arm T-DXd monotherapy
Overall Study Death	77
Overall Study Lost to Follow-up	3

Baseline Characteristics

Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T-DXd Arm n=95 Participants T-DXd monotherapy
Age, Continuous	60 Years n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	73 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 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	95 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	0 Participants n=99 Participants
Race (NIH/OMB) White	0 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

PRIMARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months

Population: HER2-positive Full analysis set

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)	28.8 Percentage of Participants Interval 18.8 to 40.6

PRIMARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months

Population: HER2-positive Full analysis set

The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) Complete response (confirmed after at least 4 weeks)	1 Participants
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) Partial response (confirmed after at least 4 weeks)	20 Participants
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) Stable disease	37 Participants
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) Progression	14 Participants
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) Not evaluable	1 Participants

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Based on Independent Central Review (ICR)	5.7 Months Interval 4.0 to 6.8

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 3 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR)	69.0 Percentage of participants Interval 56.8 to 78.4

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 6 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR)	43.4 Percentage of participants Interval 30.8 to 55.3

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 9 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR)	27.1 Percentage of participants Interval 16.2 to 39.3

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 12 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR)	16.7 Percentage of participants Interval 8.0 to 28.1

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 15 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 15 Months Based on Independent Central Review (ICR)	11.9 Percentage of participants Interval 4.7 to 22.8

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 18 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 18 Months Based on Independent Central Review (ICR)	4.0 Percentage of participants Interval 0.4 to 15.6

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 21 months using the Kaplan-Meier technique

Population: HER2-positive Full analysis set

PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Progression-free Survival (PFS) Rate at 21 Months Based on Independent Central Review (ICR)	4.0 Percentage of participants Interval 0.4 to 15.6

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months

Population: HER2-positive Full analysis set

Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD)

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Disease Control Rate (DCR) Based on Independent Central Review (ICR)	79.5 Percentage of participants Interval 68.4 to 88.0

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12

Population: HER2-positive Full analysis set

Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD) for at least 11 weeks (ie 12 weeks - 1 week to allow for an early assessment within the assessment window)

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12	74.0 Percentage of participants Interval 62.4 to 83.5

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months

Population: HER2-positive Full analysis set

DoR defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) or death in the absence of progression based on investigator assessments by using RECIST version 1.1

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Duration of Response (DoR) Based on Independent Central Review (ICR)	6.7 Months Interval 4.6 to 8.8

SECONDARY outcome

Timeframe: From date of enrolment until death due to any cause. Assessed up to approximately 30 months (from date of first subject in to data cut-off 28February2024)

Population: HER2-positive Full analysis set

OS based on ICR is defined as the time from date of enrolment until the date of death due to any cause

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Overall Survival (OS) Based on Independent Central Review (ICR)	11.1 Months Interval 7.7 to 13.7

SECONDARY outcome

Timeframe: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months

Population: HER2-positive Full analysis set

Best percentage change based on ICR is defined as the best change in target lesion tumour size from baseline (maximum reduction or minimum increase from baseline in the absence of a reduction)

Outcome measures

Outcome measures
Measure	T-DXd Arm n=73 Participants T-DXd monotherapy
Best Percentage Change in Sum of Diameters of Measurable Tumours Based on Independent Central Review (ICR)	-22.55 Percentage Change Standard Deviation 29.682

Adverse Events

T-DXd

Serious events: 40 serious events

Other events: 93 other events

Deaths: 77 deaths

Serious adverse events

Serious adverse events
Measure	T-DXd n=95 participants at risk Description (Arm-group)
Gastrointestinal disorders Dysphagia	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Vomiting	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Asthenia	4.2% 4/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Anaemia	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Hepatobiliary disorders Hepatic function abnormal	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Hepatobiliary disorders Jaundice cholestatic	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Covid-19 pneumonia	4.2% 4/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Gastrointestinal infection	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Febrile neutropenia	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Myelosuppression	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Platelet count decreased	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations White blood cell count decreased	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Thrombocytopenia	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Malnutrition	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Nervous system disorders Cerebral infarction	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Cardiac disorders Arrhythmia	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Psychiatric disorders Mental disorder	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Abdominal distension	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	3.2% 3/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Death	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Fatigue	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Covid-19	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Pneumonia	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Sepsis	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Neutrophil count decreased	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Decreased appetite	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypoalbuminaemia	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypokalaemia	2.1% 2/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Nervous system disorders Haemorrhage intracranial	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Renal and urinary disorders Haematuria	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Renal and urinary disorders Renal failure	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Vascular disorders Deep vein thrombosis	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Abdominal pain	1.1% 1/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)

Other adverse events

Other adverse events
Measure	T-DXd n=95 participants at risk Description (Arm-group)
Gastrointestinal disorders Diarrhoea	14.7% 14/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Nausea	43.2% 41/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Asthenia	25.3% 24/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Anaemia	76.8% 73/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Fatigue	18.9% 18/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Oedema peripheral	7.4% 7/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Hepatobiliary disorders Hepatic function abnormal	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Covid-19	12.6% 12/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Alanine aminotransferase increased	25.3% 24/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Amylase increased	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Aspartate aminotransferase increased	31.6% 30/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Bilirubin conjugated increased	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Blood alkaline phosphatase increased	11.6% 11/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Blood bilirubin increased	11.6% 11/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Blood creatinine increased	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Blood lactate dehydrogenase increased	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Ejection fraction decreased	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Gamma-glutamyltransferase increased	11.6% 11/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Lymphocyte count decreased	16.8% 16/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Neutrophil count decreased	61.1% 58/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Platelet count decreased	52.6% 50/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations Weight decreased	28.4% 27/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations White blood cell count decreased	72.6% 69/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Investigations White blood cell count increased	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Decreased appetite	40.0% 38/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hyperglycaemia	8.4% 8/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hyperuricaemia	9.5% 9/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Blood and lymphatic system disorders Thrombocytopenia	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypoalbuminaemia	38.9% 37/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypocalcaemia	24.2% 23/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypochloraemia	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypokalaemia	26.3% 25/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hypoproteinaemia	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Musculoskeletal and connective tissue disorders Back pain	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Nervous system disorders Dizziness	9.5% 9/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Respiratory, thoracic and mediastinal disorders Cough	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Abdominal distension	8.4% 8/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Abdominal pain	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Constipation	18.9% 18/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Dyspepsia	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Mouth ulceration	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Gastrointestinal disorders Vomiting	31.6% 30/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
General disorders Pyrexia	9.5% 9/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Infections and infestations Coronavirus infection	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Metabolism and nutrition disorders Hyponatraemia	22.1% 21/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Nervous system disorders Hypoaesthesia	6.3% 6/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Psychiatric disorders Insomnia	7.4% 7/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)
Respiratory, thoracic and mediastinal disorders Productive cough	5.3% 5/95 • From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months)

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place