Trial Outcomes & Findings for PhII ICb With/Without Erbitux in MBC Pts (NCT NCT00248287)

Last Updated: 2025-01-29

Results Overview

To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

154 participants

Primary outcome timeframe

2 years

Results posted on

2025-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Irinotecan+Carboplatin Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab Patients treated with Irinotecan + Carboplatin + Cetuximab
Overall Study STARTED	75	79
Overall Study COMPLETED	51	60
Overall Study NOT COMPLETED	24	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Irinotecan+Carboplatin Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab Patients treated with Irinotecan + Carboplatin + Cetuximab
Overall Study Adverse Event	11	10
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Investigator Request	4	3
Overall Study Patient Request	5	3
Overall Study Other	3	2

Baseline Characteristics

PhII ICb With/Without Erbitux in MBC Pts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Irinotecan+Carboplatin n=75 Participants Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=79 Participants Patients treated with Irinotecan + Carboplatin + Cetuximab	Total n=154 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 11.4 • n=5 Participants	54.9 years STANDARD_DEVIATION 10.7 • n=7 Participants	54.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	79 Participants n=7 Participants	154 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 Caucasian	59 participants n=5 Participants	69 participants n=7 Participants	128 participants n=5 Participants
Race/Ethnicity, Customized Black	14 participants n=5 Participants	8 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	79 participants n=7 Participants	154 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Evaluable population

Outcome measures

Outcome measures
Measure	Irinotecan+Carboplatin n=66 Participants Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=71 Participants Patients treated with Irinotecan + Carboplatin + Cetuximab
Objective Response Rates (ORR)	36.4 Percentage of Participants Interval 24.9 to 49.1	36.6 Percentage of Participants Interval 25.5 to 48.9

SECONDARY outcome

Timeframe: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.

Population: For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Outcome measures

Outcome measures
Measure	Irinotecan+Carboplatin n=24 Participants Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=26 Participants Patients treated with Irinotecan + Carboplatin + Cetuximab
Duration of Response	5.4 months Interval 2.0 to 34.3	6.0 months Interval 1.4 to 41.3

SECONDARY outcome

Timeframe: 2 years

Population: ITT population

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

Outcome measures

Outcome measures
Measure	Irinotecan+Carboplatin n=75 Participants Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=79 Participants Patients treated with Irinotecan + Carboplatin + Cetuximab
Median Time of Progression-free Survival (PFS)	4.4 months Interval 3.2 to 5.8	4.6 months Interval 3.5 to 5.5

SECONDARY outcome

Timeframe: 2 years

Population: ITT population

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

Outcome measures

Outcome measures
Measure	Irinotecan+Carboplatin n=75 Participants Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=79 Participants Patients treated with Irinotecan + Carboplatin + Cetuximab
Median Overall Survival (OS)	12.5 months Interval 10.6 to 17.1	14.6 months Interval 10.4 to 16.9

Adverse Events

Irinotecan+Carboplatin

Serious events: 14 serious events

Other events: 73 other events

Deaths: 1 deaths

Irinotecan+Carboplatin+Cetuximab

Serious events: 18 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Joyce O'Shaughnessy

Baylor Sammons Cancer Center

Phone: (214) 370 -1796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Irinotecan+Carboplatin n=75 participants at risk Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=79 participants at risk Patients treated with Irinotecan + Carboplatin + Cetuximab
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Immune system disorders ALLERGIC REACTION	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Immune system disorders ANAPHYLAXIS	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders ANEMIA	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Infections and infestations BACTERIAL RESISTANCE	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders CONFUSION	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Cardiac disorders CONGESTIVE HEART FAILURE	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DEHYDRATION	10.7% 8/75 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	7.6% 6/79 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DIARRHEA	6.7% 5/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	11.4% 9/79 • Number of events 10 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders EMBOLISM PULMONARY	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders FEVER	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders HYPERBILIRUBINEMIA	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders HYPERSENSITIVITY REACTION (NOS)	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders HYPOCALCEMIA	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders HYPOMAGNESEMIA	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Vascular disorders HYPOTENSION	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders INFECTION UPPER RESPIRATORY	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA AND VOMITING	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders NEUTROPENIA	4.0% 3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders REACTION INJECTION SITE (NOS)	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Infections and infestations SEPSIS	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEAKNESS GENERALIZED	2.7% 2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	0.00% 0/79 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.

Measure	Irinotecan+Carboplatin n=75 participants at risk Patients treated with Irinotecan + Carboplatin	Irinotecan+Carboplatin+Cetuximab n=79 participants at risk Patients treated with Irinotecan + Carboplatin + Cetuximab
Gastrointestinal disorders ABDOMINAL PAIN	14.7% 11/75 • Number of events 13 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	24.1% 19/79 • Number of events 30 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders ACNE	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	6.3% 5/79 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Immune system disorders ALLERGIC REACTION	1.3% 1/75 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	6.3% 5/79 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders ALOPECIA	26.7% 20/75 • Number of events 23 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	34.2% 27/79 • Number of events 29 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders ANEMIA	62.7% 47/75 • Number of events 189 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	50.6% 40/79 • Number of events 132 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders ANOREXIA	24.0% 18/75 • Number of events 23 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	24.1% 19/79 • Number of events 23 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders AST INCREASED	2.7% 2/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	7.6% 6/79 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders CONSTIPATION	20.0% 15/75 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	13.9% 11/79 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders COUGH	4.0% 3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	8.9% 7/79 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DEHYDRATION	12.0% 9/75 • Number of events 9 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	17.7% 14/79 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders DIARRHEA	66.7% 50/75 • Number of events 91 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	73.4% 58/79 • Number of events 130 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Nervous system disorders DIZZINESS	8.0% 6/75 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	11.4% 9/79 • Number of events 16 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders DRY SKIN	5.3% 4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	24.1% 19/79 • Number of events 20 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders EDEMA	2.7% 2/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders FATIGUE	60.0% 45/75 • Number of events 105 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	64.6% 51/79 • Number of events 110 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders FEVER	12.0% 9/75 • Number of events 10 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX	13.3% 10/75 • Number of events 12 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	13.9% 11/79 • Number of events 13 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders HEADACHE	2.7% 2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	7.6% 6/79 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders HOT FLASHES	6.7% 5/75 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	1.3% 1/79 • Number of events 1 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders HYPOKALEMIA	13.3% 10/75 • Number of events 14 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	17.7% 14/79 • Number of events 26 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	14.7% 11/75 • Number of events 30 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	27.8% 22/79 • Number of events 43 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Vascular disorders HYPOTENSION	5.3% 4/75 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	2.5% 2/79 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders LEUCOPENIA	38.7% 29/75 • Number of events 177 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	40.5% 32/79 • Number of events 170 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders LYMPHOPENIA	6.7% 5/75 • Number of events 39 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	6.3% 5/79 • Number of events 24 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Infections and infestations MUCOSITIS	9.3% 7/75 • Number of events 8 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Musculoskeletal and connective tissue disorders MYALGIA	2.7% 2/75 • Number of events 12 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders NAUSEA	73.3% 55/75 • Number of events 102 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	59.5% 47/79 • Number of events 90 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Nervous system disorders NEUROPATHY	8.0% 6/75 • Number of events 17 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	10.1% 8/79 • Number of events 11 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders NEUTROPENIA	70.7% 53/75 • Number of events 242 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	70.9% 56/79 • Number of events 257 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders PAIN	8.0% 6/75 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	3.8% 3/79 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Nervous system disorders PARESTHESIA	2.7% 2/75 • Number of events 2 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 4 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Metabolism and nutrition disorders PHOSPHATASE ALKALINE INCREASED	2.7% 2/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/75 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	5.1% 4/79 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Skin and subcutaneous tissue disorders RASH	18.7% 14/75 • Number of events 22 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	70.9% 56/79 • Number of events 105 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	5.3% 4/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	6.3% 5/79 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders STOMATITIS	4.0% 3/75 • Number of events 3 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	6.3% 5/79 • Number of events 6 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Blood and lymphatic system disorders THROMBOCYTOPENIA	52.0% 39/75 • Number of events 138 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	40.5% 32/79 • Number of events 90 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
Gastrointestinal disorders VOMITING	40.0% 30/75 • Number of events 38 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	43.0% 34/79 • Number of events 50 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEAKNESS	5.3% 4/75 • Number of events 7 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	12.7% 10/79 • Number of events 14 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.
General disorders WEIGHT LOSS	5.3% 4/75 • Number of events 5 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.	15.2% 12/79 • Number of events 17 • During the whole treatment period, up to 30 days following last dose. For treated patients only, assessed at each treatment visit.