Trial Outcomes & Findings for A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer (NCT NCT01629615)

Last Updated: 2020-10-28

Results Overview

Clinical benefit rate (CBR) was defined as the percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is the complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.

Results posted on

2020-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	BKM120 BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BKM120 n=50 Participants BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Age, Continuous	53 years n=93 Participants
Sex: Female, Male Female	50 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	27 participants n=93 Participants
Region of Enrollment Spain	23 participants n=93 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.

Population: Intent-to-treat population was all recruited population that receives the study treatment

Outcome measures

Outcome measures
Measure	BKM120 n=50 Participants BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Rate of Clinical Benefit Complete response	0 Participants
Rate of Clinical Benefit Partial response	0 Participants
Rate of Clinical Benefit Stable disease > 4 months	6 Participants
Rate of Clinical Benefit Stable disease < 4 months	11 Participants
Rate of Clinical Benefit Progressive disease	20 Participants
Rate of Clinical Benefit No evaluable	13 Participants

SECONDARY outcome

Population: Progression-free survival was analyzed in the intent-to-treat population, defined as all recruited population that receives the study treatment.

Progression-free survival (PFS) based on the Kaplan-Meier (KM) method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. Per RECIST 1.1 criteria: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure	BKM120 n=50 Participants BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Progression-free Survival	1.8 Months Interval 1.6 to 2.3

SECONDARY outcome

Timeframe: 2 years

Population: Overall survival was analyzed in the Intent-to-treat population, defined as all recruited population that receives the study treatment

Overall survival was defined as the time from date of study enrollment until death from any cause.

Outcome measures

Outcome measures
Measure	BKM120 n=50 Participants BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Overall Survival	11.2 Months Interval 6.2 to 25.0

SECONDARY outcome

Timeframe: Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants were followed for AEs on average approximately 2 months.

Population: The safety population was defined as all the patients who received at least one dose of the study drug

Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per Common Toxicity Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	BKM120 n=50 Participants BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Frequency and Severity of Adverse Events Serious Adverse events	17 Participants
Frequency and Severity of Adverse Events Other Adverse events	44 Participants

Adverse Events

BKM120

Serious events: 17 serious events

Other events: 44 other events

Deaths: 29 deaths

Serious adverse events

Serious adverse events
Measure	BKM120 n=50 participants at risk BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
General disorders Fatigue	8.0% 4/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Papulopustular rash	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alanine aminotransferase increased	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Aspartate aminotransferase increased	8.0% 4/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Alkalosis	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Anorexia	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycemia	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Nervous system disorders - Other	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Dry skin	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.

Other adverse events

Other adverse events
Measure	BKM120 n=50 participants at risk BKM120: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
Blood and lymphatic system disorders Anemia	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Eye disorders Watering eyes	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Eye disorders Eye disorders - Other	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Bloating	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Dyspepsia	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhea	18.0% 9/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Mucositis oral	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Nausea	32.0% 16/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Rectal hemorrhage	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Gastrointestinal disorders - Other	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigue	48.0% 24/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fever	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Non-cardiac chest pain	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pain	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
General disorders General disorders and administration site conditions - Other	6.0% 3/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Hepatobiliary disorders Hepatic failure	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Immune system disorders Allergic reaction	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Papulopustular rash	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Upper respiratory infection	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Urinary tract infection	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Infections and infestations - Other	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Injury, poisoning and procedural complications Fracture	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alanine aminotransferase increased	16.0% 8/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alkaline phosphatase increased	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Aspartate aminotransferase increased	12.0% 6/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Weight loss	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Investigations - Other, specify	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Anorexia	28.0% 14/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyperglycemia	32.0% 16/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypomagnesemia	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatremia	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Back pain	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Dizziness	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Dysgeusia	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Headache	6.0% 3/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Peripheral sensory neuropathy	6.0% 3/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Somnolence	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Anxiety	16.0% 8/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Depression	14.0% 7/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Insomnia	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Libido increased	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Psychiatric disorders Psychiatric disorders - Other	14.0% 7/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Cystitis noninfective	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Hematuria	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Reproductive system and breast disorders Breast pain	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.0% 4/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Dry skin	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Photosensitivity	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Pruritus	6.0% 3/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 5/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.0% 3/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	4.0% 2/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Hypertension	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Lymphedema	2.0% 1/50 • Adverse events (AEs) were assessed every 2 weeks for the first 2 cycles and every cycle thereafter. Participants in this study cohort were followed for AEs on average approximately 2 months. Safety assessments consisted of monitoring by investigators and recording all adverse events, serious adverse events, and the regular monitoring of laboratory evaluations, physical examination, weight, vital signs, and ECG. Adverse events were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.

Additional Information

Scientific Manager

SOLTI

Phone: (+34) 93 343 63 02

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place