Trial Outcomes & Findings for A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer (NCT NCT02561832)

NCT ID: NCT02561832

Last Updated: 2019-02-20

Results Overview

Treatment-emergent AEs (TEAEs) defined as events occurring on or after cycle 1, day 1 up to and including 30 days after last dose (approximately 114 days).

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: From day 1 cycle 1, up to and including 30 days after last dose
• Results posted on: 2019-02-20

Participant Flow

Patients were screened between 06 November 2015 and 02 June 2016 at 7 medical centers in 2 countries

At screening, consenting patients were assessed to ensure that they met eligibility criteria. Once eligibility criteria were confirmed, patients underwent assessments applicable for the visit. Procedures that were part of standard of care may have occurred before informed consent was obtained.

Participant milestones

Measure	Cohort 1 Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 week	Cohort 2 Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
Overall Study STARTED	8	7
Overall Study INFORMED CONSENT OBTAINED	8	7
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	Cohort 1 Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 week	Cohort 2 Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	3	0
Overall Study Disease progression	3	3

Baseline Characteristics

A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

Baseline characteristics by cohort

Measure	Cohort 1 n=8 Participants Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 week	Cohort 2 n=7 Participants Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks	Total n=15 Participants Total of all reporting groups
Age, Continuous	54.1 Years STANDARD_DEVIATION 14.57 • n=5 Participants	47.7 Years STANDARD_DEVIATION 16.18 • n=7 Participants	51.1 Years STANDARD_DEVIATION 15.15 • n=5 Participants
Age, Customized >=18 to <33	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized >=33 to <50	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized >=50 to <65	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized >=65	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: From day 1 cycle 1, up to and including 30 days after last dose

Population: Safety analysis set consisting of all subjects who received at least one dose of study treatment

Treatment-emergent AEs (TEAEs) defined as events occurring on or after cycle 1, day 1 up to and including 30 days after last dose (approximately 114 days).

Outcome measures

Measure	Cohort 1 n=8 Participants Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 weeks	Cohort 2 n=7 Participants Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
Part A: Number of Subjects Reporting Adverse Events (AEs)	8 Participants	7 Participants

Adverse Events

Cohort 1

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 n=8 participants at risk Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 weeks	Cohort 2 n=7 participants at risk Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Injury, poisoning and procedural complications Femur fracture	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Platelet count decreased	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Spinal cord compression	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.

Other adverse events

Measure	Cohort 1 n=8 participants at risk Olaparib 50mg, bid days 4 to 19 Carboplatin AUC5 on day 1 every 3 weeks	Cohort 2 n=7 participants at risk Olaparib 50mg, bid days 4 to 11 Carboplatin AUC5 on day 1 every 3 weeks
Blood and lymphatic system disorders Anaemia	100.0% 8/8 • Number of events 10 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	42.9% 3/7 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Blood and lymphatic system disorders Leukopenia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Blood and lymphatic system disorders Neutropenia	50.0% 4/8 • Number of events 10 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	42.9% 3/7 • Number of events 10 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Blood and lymphatic system disorders Thrombocytopenia	37.5% 3/8 • Number of events 10 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Eye disorders Eye pain	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Eye disorders Vitreous floaters	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Constipation	50.0% 4/8 • Number of events 5 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Gingival bleeding	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Nausea	37.5% 3/8 • Number of events 4 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	57.1% 4/7 • Number of events 10 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Stomatitis	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
General disorders Asthenia	37.5% 3/8 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
General disorders Axillary pain	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
General disorders Catheter site erythema	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
General disorders Fatigue	37.5% 3/8 • Number of events 6 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
General disorders Pyrexia	25.0% 2/8 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Infections and infestations Postoperative wound infection	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Blood creatinine increased	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Haemoglobin decreased	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Neutrophil count decreased	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Platelet count decreased	37.5% 3/8 • Number of events 5 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	42.9% 3/7 • Number of events 5 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations Weight decreased	25.0% 2/8 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Investigations White blood cell count decreased	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Metabolism and nutrition disorders Decreased appetite	25.0% 2/8 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Musculoskeletal and connective tissue disorders Back pain	25.0% 2/8 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Aphonia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Dizziness	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	28.6% 2/7 • Number of events 4 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	42.9% 3/7 • Number of events 3 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Nervous system disorders Presyncope	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Psychiatric disorders Anxiety	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Psychiatric disorders Insomnia	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Renal and urinary disorders Dysuria	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Respiratory, thoracic and mediastinal disorders Productive cough	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	14.3% 1/7 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.
Skin and subcutaneous tissue disorders Skin haemorrhage	12.5% 1/8 • Number of events 1 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.	0.00% 0/7 • AEs, including SAEs, were collected from time of signature of informed consent throughout the Treatment period (four 3-week cycles) up to and including the 30-day Follow-up period (approximately 142 days). All ongoing and any new AEs/SAEs identified during the 30-calendar day Follow-up period, after the last dose of study medication were required to be followed to resolution.

Additional Information

Carsten Goessl MD

AstraZeneca Pharmaceuticals LP

Phone: +1 2404490654

Email: Carsten.Goessl@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place