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Trial Outcomes & Findings for Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer (NCT NCT01132664)

NCT ID: NCT01132664

Last Updated: 2016-08-17

Results Overview

Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

72 participants

Primary outcome timeframe

cycle 1 - 28 days

Results posted on

2016-08-17

Participant Flow

72 patients (pts) were enrolled: 18 in ph lb, 53 in ph ll, including 8 from ph lb, with 45 new pts in ph ll \& 9 in the brain metastasis (BM) cohort. Of the 72 pts, 1 in ph lb \& 3 in phase ll, did not receive Burparlisib, only Trastuzumab. Therefore, 68 patients (17 in ph l, 42 in ph ll, 9 in BM cohort) were treated with buparlisib + trastuzumab.

Primary outcome measure for BM cohort was MTD/RP2D which was not reached/established due to premature termination of the study. Objective Response Rate (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR) \& Progression Free Survival (PFS)were not calculated for the BM cohort either.

Participant milestones

Participant milestones
Measure
Phase Ib - 50 mg
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Phase lb
STARTED
5
12
0
0
0
Phase lb
COMPLETED
0
0
0
0
0
Phase lb
NOT COMPLETED
5
12
0
0
0
Phase ll
STARTED
0
0
50
0
0
Phase ll
COMPLETED
0
0
0
0
0
Phase ll
NOT COMPLETED
0
0
50
0
0
BM Cohort
STARTED
0
0
0
3
6
BM Cohort
COMPLETED
0
0
0
0
0
BM Cohort
NOT COMPLETED
0
0
0
3
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase Ib - 50 mg
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Phase lb
Adverse Event
0
1
0
0
0
Phase lb
Withdrawal by Subject
1
2
0
0
0
Phase lb
Disease Progression
4
9
0
0
0
Phase ll
Death
0
0
2
0
0
Phase ll
Adverse Event
0
0
10
0
0
Phase ll
Withdrawal by Subject
0
0
3
0
0
Phase ll
Disease progression
0
0
35
0
0
BM Cohort
Disease progression
0
0
0
3
4
BM Cohort
Adverse Event
0
0
0
0
1
BM Cohort
Withdrawal by Subject
0
0
0
0
1

Baseline Characteristics

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase Ib - 50 mg
n=5 Participants
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
n=12 Participants
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
n=42 Participants
Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
BM Cohort - 80mg
n=3 Participants
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
n=6 Participants
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Total
n=68 Participants
Total of all reporting groups
Age, Customized
<65 years
5 Participants
n=5 Participants
11 Participants
n=7 Participants
35 Participants
n=5 Participants
3 Participants
n=4 Participants
6 Participants
n=21 Participants
60 Participants
n=10 Participants
Age, Customized
>=65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
7 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
8 Participants
n=10 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
12 Participants
n=7 Participants
42 Participants
n=5 Participants
3 Participants
n=4 Participants
6 Participants
n=21 Participants
68 Participants
n=10 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Female: Child bearing potential
Able to bear children
2 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
15 Participants
n=10 Participants
Female: Child bearing potential
Premenarche
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Female: Child bearing potential
Post-menopausal
3 Participants
n=5 Participants
8 Participants
n=7 Participants
31 Participants
n=5 Participants
2 Participants
n=4 Participants
4 Participants
n=21 Participants
48 Participants
n=10 Participants
Female: Child bearing potential
Sterile - of child bearing age
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
5 Participants
n=10 Participants

PRIMARY outcome

Timeframe: cycle 1 - 28 days

Population: The Dose-determining set (DDS) for the determination of the MTD consisted of all patients from the safety set in the dose escalation phase who had met the minimum safety evaluation requirements and the minimum exposure criterion or had experienced DLT during Cycle 1 and were discontinued. MTD analysis was done only on the phase lb group.

Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.

Outcome measures

Outcome measures
Measure
Phase Ib - 50 mg
n=4 Participants
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
n=11 Participants
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
Patients in the phase II expansion + patients from phase Ib escalation included in phase II
BM Cohort - 80mg
n=3 Participants
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
n=5 Participants
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Dose Limiting Toxicity (DLT) - Phase l Only
Primary system orgran class (SOC) PT - grade 1
0 Participants
0 Participants
—
0 Participants
0 Participants
Dose Limiting Toxicity (DLT) - Phase l Only
Primary SOC PT - grade 2
0 Participants
0 Participants
—
0 Participants
0 Participants
Dose Limiting Toxicity (DLT) - Phase l Only
Primary SOC PT (asthenia) - grade 3
0 Participants
1 Participants
—
0 Participants
0 Participants
Dose Limiting Toxicity (DLT) - Phase l Only
Primary SOC PT - grade 4
0 Participants
0 Participants
—
0 Participants
0 Participants
Dose Limiting Toxicity (DLT) - Phase l Only
Primary SOC PT - missing
0 Participants
0 Participants
—
0 Participants
0 Participants
Dose Limiting Toxicity (DLT) - Phase l Only
Primary SOC PT (somatits/diarrhea) - grade 3
0 Participants
0 Participants
—
0 Participants
1 Participants

PRIMARY outcome

Timeframe: 18 months

Population: The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib)

Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review. Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= \>=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR.

Outcome measures

Outcome measures
Measure
Phase Ib - 50 mg
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
n=50 Participants
Patients in the phase II expansion + patients from phase Ib escalation included in phase II
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Overall Response Rate (ORR) - Phase ll
—
—
5 Participants
—
—

SECONDARY outcome

Timeframe: 18 months

Population: The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib). CBR analysis was not done for the BM cohort population. DCR analysis was not done for the BM cohort population.

Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = \>=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

Outcome measures

Outcome measures
Measure
Phase Ib - 50 mg
n=5 Participants
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
n=12 Participants
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
n=50 Participants
Patients in the phase II expansion + patients from phase Ib escalation included in phase II
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll
Phase l
1 Participants
7 Participants
0 Participants
—
—
Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll
Phase ll
0 Participants
0 Participants
25 Participants
—
—

SECONDARY outcome

Timeframe: 18 months

Population: The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib). CBR analysis was not done for the BM cohort population.

CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator. Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= \>=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

Outcome measures

Outcome measures
Measure
Phase Ib - 50 mg
n=5 Participants
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
n=12 Participants
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
n=50 Participants
Patients in the phase II expansion + patients from phase Ib escalation included in phase II
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Clinical Benefit Rate (CBR) - Phase l & ll
Phase l
0 Participants
3 Participants
0 Participants
—
—
Clinical Benefit Rate (CBR) - Phase l & ll
Phase ll
0 Participants
0 Participants
7 Participants
—
—

SECONDARY outcome

Timeframe: 18 months

Population: FAS consisted of all patients who received at least 1 dose of study drug (buparlisib). PFS analysis was not done for the BM cohort population. MTD/RP2D was not established due to premature termination of the study. In the phase ll portion of the study, PFS was analyzed only in patients with known PIK3 status, thus only 26/50 patients were analyzed.

Outcome measures

Outcome measures
Measure
Phase Ib - 50 mg
n=5 Participants
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
Phase Ib - 100mg
n=12 Participants
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II - 100mg
n=26 Participants
Patients in the phase II expansion + patients from phase Ib escalation included in phase II
BM Cohort - 80mg
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort - 100mg
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll
Phase ll: PIK3CA mutated (n =8)
NA Months
NA = data reported here for phase ll only and not for phase l
NA Months
NA = data reported here for phase ll only and not for phase l
1.8 Months
Interval 1.3 to 3.4
—
—
Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll
Phase l
1.7 Months
Interval 1.3 to 3.6
3.3 Months
Interval 1.6 to 5.4
NA Months
NA = data reported here for phase l only and not for phase ll
—
—
Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll
Phase ll: PIK3CA wildtype (n =18)
NA Months
NA = data reported here for phase ll only and not for phase l
NA Months
NA = data reported here for phase ll only and not for phase l
1.7 Months
Interval 1.5 to 5.4
—
—

Adverse Events

Phase Ib Dose Escalation 50 mg/Day

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Phase Ib Dose Escalation 100 mg/Day

Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths

Phase II Dose Expansion 100 mg/Day

Serious events: 17 serious events
Other events: 50 other events
Deaths: 0 deaths

BM Cohort 80 mg/Day

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

BM Cohort 100 mg/Day

Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Phase Ib Dose Escalation 50 mg/Day
n=5 participants at risk
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
Phase Ib Dose Escalation 100 mg/Day
n=12 participants at risk
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II Dose Expansion 100 mg/Day
n=50 participants at risk
Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
BM Cohort 80 mg/Day
n=3 participants at risk
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort 100 mg/Day
n=6 participants at risk
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Blood and lymphatic system disorders
Anaemia
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Abdominal Pain Upper
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Constipation
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Diarrhoea
0.00%
0/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Nausea
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Vomiting
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
General disorders
Asthenia
0.00%
0/5
16.7%
2/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
General disorders
General Physical Health Deterioration
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
General disorders
Oedema Peripheral
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
General disorders
Pain
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
General disorders
Systemic Inflammatory Response Syndrome
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Hepatobiliary disorders
Cholelithiasis
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Hepatobiliary disorders
Hepatic Failure
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Immune system disorders
Hypersensitivity
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Infections and infestations
Device Related Infection
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Infection
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Lobar Pneumonia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Infections and infestations
Lower Respiratory Tract Infection
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Infections and infestations
Lung Infection
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Sepsis
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Investigations
Alanine Aminotransferase Increased
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Investigations
Aspartate Aminotransferase Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Bilirubin Conjugated Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Bilirubin Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Diabetic Ketoacidosis
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hypercreatininaemia
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Bone Pain
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Cerebral Haemorrhage
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Cerebrovascular Accident
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Convulsion
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Nervous system disorders
Epilepsy
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Status Epilepticus
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Affective Disorder
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Confusional State
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Delirium
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Psychiatric disorders
Depressed Mood
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Depression
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Mood Altered
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
0.00%
0/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Vascular disorders
Hypotension
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6

Other adverse events

Other adverse events
Measure
Phase Ib Dose Escalation 50 mg/Day
n=5 participants at risk
Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
Phase Ib Dose Escalation 100 mg/Day
n=12 participants at risk
Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
Phase II Dose Expansion 100 mg/Day
n=50 participants at risk
Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
BM Cohort 80 mg/Day
n=3 participants at risk
Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
BM Cohort 100 mg/Day
n=6 participants at risk
Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
Gastrointestinal disorders
Tooth Disorder
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Blood and lymphatic system disorders
Anaemia
0.00%
0/5
8.3%
1/12
10.0%
5/50
0.00%
0/3
0.00%
0/6
Blood and lymphatic system disorders
Neutropenia
0.00%
0/5
0.00%
0/12
0.00%
0/50
66.7%
2/3
0.00%
0/6
Cardiac disorders
Palpitations
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Ear and labyrinth disorders
Tinnitus
0.00%
0/5
0.00%
0/12
6.0%
3/50
33.3%
1/3
0.00%
0/6
Eye disorders
Dry Eye
0.00%
0/5
16.7%
2/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Eye disorders
Extraocular Muscle Paresis
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Eye disorders
Eye Irritation
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Eye disorders
Eye Pain
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Eye disorders
Ocular Hyperaemia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Eye disorders
Photophobia
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Eye disorders
Vision Blurred
0.00%
0/5
8.3%
1/12
2.0%
1/50
66.7%
2/3
16.7%
1/6
Eye disorders
Visual Impairment
20.0%
1/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
16.7%
1/6
Gastrointestinal disorders
Abdominal Distension
0.00%
0/5
8.3%
1/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Abdominal Pain
0.00%
0/5
25.0%
3/12
14.0%
7/50
0.00%
0/3
16.7%
1/6
Gastrointestinal disorders
Abdominal Pain Lower
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Abdominal Pain Upper
20.0%
1/5
16.7%
2/12
10.0%
5/50
33.3%
1/3
16.7%
1/6
Gastrointestinal disorders
Anal Fissure
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Aphthous Stomatitis
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Cheilitis
0.00%
0/5
8.3%
1/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Constipation
20.0%
1/5
8.3%
1/12
12.0%
6/50
33.3%
1/3
33.3%
2/6
Gastrointestinal disorders
Diarrhoea
20.0%
1/5
41.7%
5/12
50.0%
25/50
100.0%
3/3
83.3%
5/6
Gastrointestinal disorders
Dry Mouth
0.00%
0/5
8.3%
1/12
4.0%
2/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Dyspepsia
0.00%
0/5
8.3%
1/12
12.0%
6/50
100.0%
3/3
0.00%
0/6
Gastrointestinal disorders
Dysphagia
0.00%
0/5
0.00%
0/12
6.0%
3/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Flatulence
0.00%
0/5
8.3%
1/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Haematochezia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
16.7%
1/6
Gastrointestinal disorders
Haemorrhoids
0.00%
0/5
8.3%
1/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Haemorrhoids Thrombosed
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Lip Ulceration
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Mouth Ulceration
0.00%
0/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Gastrointestinal disorders
Nausea
40.0%
2/5
16.7%
2/12
48.0%
24/50
66.7%
2/3
66.7%
4/6
Gastrointestinal disorders
Pigmentation Lip
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Stomatitis
0.00%
0/5
33.3%
4/12
24.0%
12/50
33.3%
1/3
33.3%
2/6
Gastrointestinal disorders
Tongue Discolouration
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Toothache
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Gastrointestinal disorders
Vomiting
40.0%
2/5
16.7%
2/12
26.0%
13/50
33.3%
1/3
66.7%
4/6
General disorders
Asthenia
20.0%
1/5
50.0%
6/12
26.0%
13/50
0.00%
0/3
16.7%
1/6
General disorders
Chest Pain
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
General disorders
Face Oedema
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
General disorders
Fatigue
0.00%
0/5
0.00%
0/12
32.0%
16/50
100.0%
3/3
66.7%
4/6
General disorders
Gait Disturbance
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
General disorders
Injection Site Reaction
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
General disorders
Mucosal Dryness
0.00%
0/5
16.7%
2/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
General disorders
Mucosal Inflammation
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
General disorders
Non-Cardiac Chest Pain
0.00%
0/5
0.00%
0/12
14.0%
7/50
33.3%
1/3
0.00%
0/6
General disorders
Oedema Peripheral
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
General disorders
Pain
0.00%
0/5
8.3%
1/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
General disorders
Pyrexia
20.0%
1/5
0.00%
0/12
10.0%
5/50
33.3%
1/3
16.7%
1/6
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Immune system disorders
Hypersensitivity
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Cellulitis
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Infections and infestations
Conjunctivitis
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Infections and infestations
Cystitis
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Infections and infestations
Device Related Sepsis
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Ear Infection
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Infections and infestations
Eczema Infected
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Furuncle
0.00%
0/5
8.3%
1/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Herpes Zoster
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Infections and infestations
Influenza
20.0%
1/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Nasopharyngitis
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Oral Herpes
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Paronychia
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Pharyngitis
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Infections and infestations
Sinusitis
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Infections and infestations
Urinary Tract Infection
0.00%
0/5
8.3%
1/12
4.0%
2/50
33.3%
1/3
0.00%
0/6
Injury, poisoning and procedural complications
Contusion
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Injury, poisoning and procedural complications
Fall
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Injury, poisoning and procedural complications
Rib Fracture
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Injury, poisoning and procedural complications
Spinal Fracture
20.0%
1/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Injury, poisoning and procedural complications
Tooth Fracture
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Injury, poisoning and procedural complications
Vaginal Laceration
0.00%
0/5
8.3%
1/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Injury, poisoning and procedural complications
Wound Complication
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Alanine Aminotransferase Decreased
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Investigations
Alanine Aminotransferase Increased
20.0%
1/5
33.3%
4/12
36.0%
18/50
0.00%
0/3
16.7%
1/6
Investigations
Amylase Increased
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Aspartate Aminotransferase Increased
20.0%
1/5
33.3%
4/12
34.0%
17/50
0.00%
0/3
16.7%
1/6
Investigations
Blood Alkaline Phosphatase Increased
0.00%
0/5
16.7%
2/12
14.0%
7/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Bilirubin Increased
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Calcium Decreased
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Cholesterol Increased
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Creatine Phosphokinase Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Investigations
Blood Creatinine Increased
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Glucose Decreased
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Glucose Increased
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Thyroid Stimulating Hormone Increased
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Investigations
Blood Uric Acid Increased
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
C-Reactive Protein Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Investigations
Eastern Cooperative Oncology Group Performance Status Worsened
0.00%
0/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Investigations
Ejection Fraction Decreased
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Investigations
Gamma-Glutamyltransferase Increased
20.0%
1/5
25.0%
3/12
14.0%
7/50
0.00%
0/3
0.00%
0/6
Investigations
Glycosylated Haemoglobin Increased
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Investigations
Haemoglobin Decreased
20.0%
1/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Insulin C-Peptide Increased
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Investigations
Lipase Increased
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Investigations
Liver Function Test Abnormal
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Investigations
Low Density Lipoprotein Increased
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Investigations
Lymphocyte Count Decreased
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Investigations
Protein Urine Present
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Investigations
Weight Decreased
20.0%
1/5
8.3%
1/12
14.0%
7/50
33.3%
1/3
16.7%
1/6
Investigations
White Blood Cell Count Decreased
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Metabolism and nutrition disorders
Decreased Appetite
20.0%
1/5
8.3%
1/12
36.0%
18/50
66.7%
2/3
66.7%
4/6
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hyperglycaemia
40.0%
2/5
41.7%
5/12
30.0%
15/50
33.3%
1/3
16.7%
1/6
Metabolism and nutrition disorders
Hyperphagia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/5
8.3%
1/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/5
8.3%
1/12
6.0%
3/50
33.3%
1/3
16.7%
1/6
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Metabolism and nutrition disorders
Increased Appetite
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/5
16.7%
2/12
12.0%
6/50
0.00%
0/3
33.3%
2/6
Musculoskeletal and connective tissue disorders
Bone Pain
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
16.7%
1/6
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.00%
0/5
8.3%
1/12
8.0%
4/50
66.7%
2/3
33.3%
2/6
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
20.0%
1/5
16.7%
2/12
4.0%
2/50
33.3%
1/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.00%
0/5
8.3%
1/12
10.0%
5/50
0.00%
0/3
16.7%
1/6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Balance Disorder
0.00%
0/5
8.3%
1/12
10.0%
5/50
33.3%
1/3
0.00%
0/6
Nervous system disorders
Cluster Headache
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Nervous system disorders
Dizziness
0.00%
0/5
8.3%
1/12
12.0%
6/50
33.3%
1/3
16.7%
1/6
Nervous system disorders
Dysgeusia
20.0%
1/5
8.3%
1/12
14.0%
7/50
33.3%
1/3
16.7%
1/6
Nervous system disorders
Headache
20.0%
1/5
8.3%
1/12
22.0%
11/50
33.3%
1/3
33.3%
2/6
Nervous system disorders
Memory Impairment
0.00%
0/5
0.00%
0/12
4.0%
2/50
33.3%
1/3
0.00%
0/6
Nervous system disorders
Neuropathy Peripheral
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Nervous system disorders
Paraesthesia
20.0%
1/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
16.7%
1/6
Nervous system disorders
Somnolence
20.0%
1/5
0.00%
0/12
4.0%
2/50
0.00%
0/3
0.00%
0/6
Nervous system disorders
Syncope
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Nervous system disorders
Tremor
20.0%
1/5
0.00%
0/12
6.0%
3/50
33.3%
1/3
16.7%
1/6
Psychiatric disorders
Affective Disorder
0.00%
0/5
25.0%
3/12
10.0%
5/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Anxiety
0.00%
0/5
8.3%
1/12
22.0%
11/50
33.3%
1/3
33.3%
2/6
Psychiatric disorders
Binge Eating
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Psychiatric disorders
Delirium
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Psychiatric disorders
Depressed Mood
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Psychiatric disorders
Depression
40.0%
2/5
8.3%
1/12
16.0%
8/50
0.00%
0/3
16.7%
1/6
Psychiatric disorders
Initial Insomnia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Psychiatric disorders
Insomnia
0.00%
0/5
16.7%
2/12
12.0%
6/50
33.3%
1/3
0.00%
0/6
Psychiatric disorders
Irritability
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
16.7%
1/6
Psychiatric disorders
Mood Altered
60.0%
3/5
33.3%
4/12
14.0%
7/50
0.00%
0/3
16.7%
1/6
Psychiatric disorders
Nervousness
0.00%
0/5
8.3%
1/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Psychiatric disorders
Restlessness
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Psychiatric disorders
Suicidal Ideation
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Renal and urinary disorders
Chromaturia
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Renal and urinary disorders
Dysuria
0.00%
0/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Renal and urinary disorders
Haematuria
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Renal and urinary disorders
Micturition Urgency
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Reproductive system and breast disorders
Breast Pain
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
16.7%
1/6
Reproductive system and breast disorders
Vulvovaginal Discomfort
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/5
33.3%
4/12
30.0%
15/50
66.7%
2/3
16.7%
1/6
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/5
8.3%
1/12
12.0%
6/50
33.3%
1/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Epistaxis
20.0%
1/5
0.00%
0/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
0.00%
0/5
8.3%
1/12
8.0%
4/50
33.3%
1/3
33.3%
2/6
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/5
0.00%
0/12
2.0%
1/50
33.3%
1/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Productive Cough
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Blister
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Dry Skin
0.00%
0/5
25.0%
3/12
12.0%
6/50
33.3%
1/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/5
8.3%
1/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Nail Disorder
0.00%
0/5
8.3%
1/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Night Sweats
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
0.00%
0/5
0.00%
0/12
4.0%
2/50
33.3%
1/3
50.0%
3/6
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
16.7%
1/6
Skin and subcutaneous tissue disorders
Pruritus
40.0%
2/5
25.0%
3/12
14.0%
7/50
100.0%
3/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Rash
20.0%
1/5
50.0%
6/12
32.0%
16/50
66.7%
2/3
16.7%
1/6
Skin and subcutaneous tissue disorders
Rash Generalised
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
0.00%
0/5
0.00%
0/12
6.0%
3/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Rash Pruritic
0.00%
0/5
0.00%
0/12
8.0%
4/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Skin Discolouration
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Skin Exfoliation
0.00%
0/5
8.3%
1/12
2.0%
1/50
0.00%
0/3
0.00%
0/6
Skin and subcutaneous tissue disorders
Skin Lesion
0.00%
0/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
16.7%
1/6
Skin and subcutaneous tissue disorders
Swelling Face
20.0%
1/5
0.00%
0/12
0.00%
0/50
0.00%
0/3
0.00%
0/6
Vascular disorders
Hypertension
0.00%
0/5
25.0%
3/12
12.0%
6/50
0.00%
0/3
0.00%
0/6
Vascular disorders
Orthostatic Hypotension
0.00%
0/5
0.00%
0/12
0.00%
0/50
33.3%
1/3
0.00%
0/6

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER