Trial Outcomes & Findings for Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma (NCT NCT01514188)

Last Updated: 2024-05-29

Results Overview

Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. Progressive Disease is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

Approximately 24 months

Results posted on

2024-05-29

Participant Flow

126 subjects were randomized to the intent to treat population, whereas 123 were in the safety population. 3 subjects were randomized, but not treated.

Participant milestones

Participant milestones
Measure	Doxorubicin Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Overall Study STARTED	40	83
Overall Study COMPLETED	17	50
Overall Study NOT COMPLETED	23	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxorubicin Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Overall Study Adverse Event	3	5
Overall Study Withdrawal by Subject	2	4
Overall Study Protocol Violation	2	4
Overall Study Physician Decision	0	2
Overall Study Disease Progression	13	14
Overall Study Death	1	3
Overall Study Other	2	1

Baseline Characteristics

Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxorubicin n=40 Participants Doxorubicin: Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.	INNO-206 n=83 Participants INNO-206: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles	Total n=123 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 12.42 • n=5 Participants	52.3 years STANDARD_DEVIATION 13.91 • n=7 Participants	53 years STANDARD_DEVIATION 13.44 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	45 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	38 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	61 Participants n=7 Participants	93 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma	40 Participants n=5 Participants	83 Participants n=7 Participants	123 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 24 months

Outcome measures

Outcome measures
Measure	Doxorubicin n=40 Participants Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 n=83 Participants INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Progression-free Survival	83 Days Interval 48.0 to 132.0	170 Days Interval 92.0 to 246.0

SECONDARY outcome

Timeframe: Approximately 35 months

Overall survival was measured from the date of registration (ie, assignment of subject number) to the date of death due to any cause, or the date of last contact.

Outcome measures

Outcome measures
Measure	Doxorubicin n=40 Participants Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 n=83 Participants INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Overall Survival	434 Days Interval 261.0 to 627.0	480 Days Interval 394.0 to The upper 95% Confidence Interval was not reached.

SECONDARY outcome

Timeframe: Month 4 and 6

Population: 126 subjects were randomized to the intent to treat population, whereas 123 were in the safety population. 3 subjects were randomized, but not treated.

Outcome measures

Outcome measures
Measure	Doxorubicin n=38 Participants Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 n=80 Participants INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Progression-free Survival at 4 and 6 Months Percentage of participants at 4 Months (%)	40.8 percentage of participants Interval 24.5 to 56.5	60 percentage of participants Interval 47.9 to 70.1
Progression-free Survival at 4 and 6 Months Percentage of participants at 6 Months (%)	22.9 percentage of participants Interval 10.0 to 38.9	45.7 percentage of participants Interval 33.7 to 57.0

SECONDARY outcome

Timeframe: Approximately 24 months

Objective Overall Response will be evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (i.e., improvements) in tumor measurements from baseline values will be assigned a status of CR or PR. Objective response measurements will comprise the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.

Outcome measures

Outcome measures
Measure	Doxorubicin n=38 Participants Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 n=80 Participants INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Objective Overall Response Rate (ORR)	0 Percentage of Subjects Interval 0.0 to 9.3	25 Percentage of Subjects Interval 16.0 to 35.9

SECONDARY outcome

Timeframe: 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)

Treatment will continue every 21 days until tumor progression is observed, 6 cycles of treatment are completed or unacceptable toxicity occurs.

Outcome measures

Outcome measures
Measure	Doxorubicin n=40 Participants Doxorubicin: Doxorubicin administered at 75 mg/m\^2 for up to 6 consecutive cycles.	INNO-206 n=83 Participants INNO-206: INNO-206 administered at 350 mg/m\^2 (260 mg/m\^2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Number of Participants With Treatment-related Toxicities (Adverse Events)	29 Participants	75 Participants

Adverse Events

Doxorubicin

Serious events: 8 serious events

Other events: 32 other events

Deaths: 26 deaths

INNO-206

Serious events: 33 serious events

Other events: 79 other events

Deaths: 40 deaths

Serious adverse events

Other adverse events

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Doxorubicin n=40 participants at risk Doxorubicin: Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.	INNO-206 n=83 participants at risk INNO-206: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Blood and lymphatic system disorders Febrile Neutropenia	12.5% 5/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	13.3% 11/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Anaemia	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	7.2% 6/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	3.6% 3/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Thrombocytopenia	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	2.4% 2/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Neutropenia	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Stomatitis	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	2.4% 2/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Vomiting	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	3.6% 3/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Constipation	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Gastritis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Cellulitis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	3.6% 3/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Pneumonia	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Gastroenteritis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Lower respiratory tract infection	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Neutropenic sepsis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Oral herpes	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Pertussis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Septic shock	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Tooth infection	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Infections and infestations Urinary tract infection	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Pyrexia	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	3.6% 3/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Mucosal inflammation	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	2.4% 2/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Vascular disorders Deep vein thrombosis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	2.4% 2/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Vascular disorders Hypovolaemic shock	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Cardiac disorders Atrial fibrillation	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Cardiac disorders Atrial tachycardia	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Metabolism and nutrition disorders Dehydration	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic neoplasm	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Hepatobiliary disorders Cholecystitis	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Immune system disorders Hypersensitivity	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Nervous system disorders Transient ischaemic attack	0.00% 0/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	1.2% 1/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).

Other adverse events
Measure	Doxorubicin n=40 participants at risk Doxorubicin: Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.	INNO-206 n=83 participants at risk INNO-206: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Gastrointestinal disorders Nausea	27.5% 11/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	45.8% 38/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Stomatitis	12.5% 5/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	33.7% 28/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Vomiting	17.5% 7/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	22.9% 19/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Constipation	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	14.5% 12/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Diarrhoea	17.5% 7/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	8.4% 7/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Gastrointestinal disorders Abdominal Pain	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	9.6% 8/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Anaemia	32.5% 13/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	43.4% 36/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Neutropenia	17.5% 7/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	39.8% 33/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Febrile neutropenia	17.5% 7/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	15.7% 13/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Leukopenia	10.0% 4/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	18.1% 15/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Blood and lymphatic system disorders Thrombocytopenia	15.0% 6/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	14.5% 12/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Fatigue	15.0% 6/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	28.9% 24/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Asthenia	12.5% 5/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	18.1% 15/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Pyrexia	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	16.9% 14/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Mucosal inflammation	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	12.0% 10/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
General disorders Oedema peripheral	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	4.8% 4/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Skin and subcutaneous tissue disorders Alopecia	30.0% 12/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	30.1% 25/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Metabolism and nutrition disorders Decreased appetite	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	24.1% 20/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Metabolism and nutrition disorders Hypoalbuminaemia	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	9.6% 8/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Metabolism and nutrition disorders Hypocalcaemia	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	9.6% 8/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Metabolism and nutrition disorders Hypokalaemia	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	10.8% 9/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Investigations Aspartate aminotransferase increased	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	7.2% 6/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Investigations Weight decreased	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	8.4% 7/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Investigations Blood alkaline phosphatase increased	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	8.4% 7/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Investigations Alanine aminotransferase increased	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	6.0% 5/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Respiratory, thoracic and mediastinal disorders Cough	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	9.6% 8/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 1/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	7.2% 6/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 3/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	6.0% 5/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).
Investigations Ejection fraction decreased	5.0% 2/40 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).	0.00% 0/83 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days).