Trial Outcomes & Findings for A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer (NCT NCT01617668)
NCT ID: NCT01617668
Last Updated: 2016-10-17
Results Overview
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.
COMPLETED
PHASE2
209 participants
12 weeks
2016-10-17
Participant Flow
215 patients were randomized to receive the study treatment. 105 gene expression signature positive patients were randomized to LCL161+paclitaxel (N=51) or paclitaxel only (N=54). 110 gene expression signature negative patients were randomized to LCL161+paclitaxel (N=55) or paclitaxel only (N=55).
Only 50 of 54 pts in the Paclitaxel without LCL161 (Positive group) received study drug; Only 53 of 55 pts in the Paclitaxel without LCL161 (Negative group) received study drug.
Participant milestones
| Measure |
Paclitaxel With LCL161 (Positive Group)
Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Without LCL161 (Positive Group)
Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel With LCL161 (Negative Group)
Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Without LCL161 (Negative Group)
Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
55
|
53
|
|
Overall Study
Randomized Patients
|
51
|
54
|
55
|
55
|
|
Overall Study
COMPLETED
|
38
|
41
|
32
|
38
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
23
|
15
|
Reasons for withdrawal
| Measure |
Paclitaxel With LCL161 (Positive Group)
Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Without LCL161 (Positive Group)
Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel With LCL161 (Negative Group)
Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Without LCL161 (Negative Group)
Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
0
|
12
|
5
|
|
Overall Study
Physician Decision
|
1
|
2
|
3
|
0
|
|
Overall Study
Progressive Disease
|
4
|
4
|
6
|
9
|
|
Overall Study
Subject/guardian decision
|
1
|
3
|
2
|
1
|
Baseline Characteristics
A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel With LCL161
n=106 Participants
Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Without LCL161
n=103 Participants
Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Age, Customized
< 65 years
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=51 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=50 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=55 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=53 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy
|
24.9 Percentage of Participants
Interval 14.5 to 37.8
|
23.4 Percentage of Participants
Interval 13.3 to 36.2
|
6.9 Percentage of Participants
Interval 2.2 to 15.5
|
9.1 Percentage of Participants
Interval 3.3 to 18.6
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.
To assess the number of patients who experienced a pathological response in breast.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=51 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=50 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=55 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=53 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy
|
13 Participants
Interval 14.5 to 37.8
|
12 Participants
Interval 13.3 to 36.2
|
4 Participants
Interval 2.2 to 15.5
|
5 Participants
Interval 3.3 to 18.6
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: FAS are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or 1 full or partial dose of paclitaxel alone. These values are medians of posterior distribution of difference of pCR rate between treatment arms based on a Bayesian model. 95% Confidence interval is actually 95% credible interval.
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=51 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=50 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=55 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=53 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Difference in pCR Rates Between Treatment Arms
|
1.5 Difference in percentage of participants
Interval -15.0 to 18.0
|
NA Difference in percentage of participants
NA = Difference in pCR rate between treatments is presented under LCL161 + paclitaxel column (gene expression signature positive)
|
-2.0 Difference in percentage of participants
Interval -12.7 to 8.3
|
NA Difference in percentage of participants
NA = Difference in pCR rate between treatments is presented under LCL161 + paclitaxel column (gene expression signature negative)
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score \<0.6661)
To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with LCL161 and paclitaxel. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=105 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors
|
18.2 Difference in percentage of participants
Interval 5.0 to 32.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score \<0.6661)
To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with paclitaxel only. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=102 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors
|
13.3 Difference in percentage of participants
Interval -0.4 to 27.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score \<0.6661)
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer regardless of tumor gene expression signature status. This comparison is between the 2 study treatments, regardless of gene signature status. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=105 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=102 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status
|
15.5 Percentage of participants
Interval 9.6 to 22.8
|
15.7 Percentage of participants
Interval 9.8 to 23.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score \<0.6661)
To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. The pCR in breast, regional nodes, and axilla were determined based on the America Joint Committee on Cancer Staging \[AJCC\] stages T1c, T2, N0-N2, M0) were (AJCC) pathologic staging recorded on the eCRF: a patient was considered to be a responder in breast, regional nodes, and axilla if the pathological complete response was reported for breast and if the regional lymph nodes staging was pN0 (including i-, mol-, mol+).The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=50 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=51 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=55 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=51 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
pCR Rate in Breast, Regional Nodes and Axilla
|
21.5 Percentage of participants
Interval 11.8 to 34.0
|
19.1 Percentage of participants
Interval 10.0 to 31.2
|
6.9 Percentage of participants
Interval 2.2 to 15.5
|
5.5 Percentage of participants
Interval 1.4 to 13.9
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: EAS1 - patients receiving at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature (GES) score. GES status is derived based on continuous GES score using cut-off 0.6661(pos: score ≥ 0.6661; neg: score \<0.6661). Patients with multicentric breast cancer were excluded.
To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. Rates of breast conserving surgery and mastectomy also contributed to the overall assessment of disease response and were summarized by treatment arm within each gene expression signature status. For this analysis, patients with multicentric breast cancer were excluded, as all patients in this group were expected to be treated with mastectomy.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=48 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=45 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=51 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=47 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery
Breast Conserving Surgery
|
60.4 Percentage of participants
|
60.0 Percentage of participants
|
49.0 Percentage of participants
|
44.7 Percentage of participants
|
|
Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery
Mastectomy
|
25.0 Percentage of participants
|
26.7 Percentage of participants
|
23.5 Percentage of participants
|
29.8 Percentage of participants
|
|
Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery
No Surgery
|
14.6 Percentage of participants
|
13.3 Percentage of participants
|
27.5 Percentage of participants
|
25.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)Population: Efficacy Analysis Set 1 (EAS1) is patients (pts) who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with valid gene expression signature score. All pts were considered for analysis (N). Only pts (n) with baseline \& post baseline values for the given time point were analyzed for that time point.
To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661 (positive: score ≥ 0.6661; negative: score \<0.6661); cycle = 28 days; each patient had either C1D2 or C1D9
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=50 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=51 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=55 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=51 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1
EAS1-Baseline (n: 20, 16, 21, 22)
|
1.5 % of positive tumor cells
Standard Deviation 1.6
|
1.4 % of positive tumor cells
Standard Deviation 1.3
|
1.4 % of positive tumor cells
Standard Deviation 3.3
|
2.1 % of positive tumor cells
Standard Deviation 2.8
|
|
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1
EAS1 Post-Baseline (n: 20, 16, 21, 22)
|
2.6 % of positive tumor cells
Standard Deviation 1.4
|
2.4 % of positive tumor cells
Standard Deviation 1.7
|
3.1 % of positive tumor cells
Standard Deviation 3.1
|
3.1 % of positive tumor cells
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9Population: The Efficacy Analysis Set 2 (EAS2) was the same as EAS1 except that the threshold for classifying a patient into the positive gene group was 0.7716. All the EAS2 set participants were considered for the analysis (N). Only participants (n) who had baseline and post baseline values for the given time point were analyzed for that time point.
To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Cycle = 28 days; each patient had either C1D2 or C1D9
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=34 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
n=29 Participants
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
n=71 Participants
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
n=73 Participants
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2
EAS2-Baseline (n: 13, 11, 28, 27)
|
1.3 % of positive tumor cells
Standard Deviation 1.8
|
1.6 % of positive tumor cells
Standard Deviation 1.4
|
1.5 % of positive tumor cells
Standard Deviation 2.9
|
1.9 % of positive tumor cells
Standard Deviation 2.6
|
|
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2
EAS2 Post-Baseline (n:13, 11, 28, 27)
|
2.3 % of positive tumor cells
Standard Deviation 1.4
|
2.7 % of positive tumor cells
Standard Deviation 1.9
|
3.2 % of positive tumor cells
Standard Deviation 2.7
|
2.9 % of positive tumor cells
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: cycle 1 day 1, cycle 4 day 15Population: The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.
To evaluate the PK of LCL161 when given in combination with paclitaxel.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=97 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax
Cycle 1 Day 1 (n:97)
|
2230.00 ng/mL
Full Range 1113.41 • Interval 186.0 to 4740.0
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax
Cycle 4 Day 15 (n:47)
|
2310.00 ng/mL
Full Range 1161.75 • Interval 491.0 to 5250.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: cycle 1 day 1, cycle 4 day 15Population: The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.
To evaluate the PK of LCL161 when given in combination with paclitaxel. The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161.
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=97 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax
Cycle 1 Day 1 (n:97)
|
3.72 h
Full Range 1113.41 • Interval 0.5 to 5.8
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax
Cycle 4 Day 15 (n:47)
|
3.50 h
Full Range 1161.75 • Interval 1.0 to 4.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: cycle 1 day 1, cycle 4 day 15Population: The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.
To evaluate the PK of LCL161 when given in combination with paclitaxel
Outcome measures
| Measure |
LCL161 + Paclitaxel (Gene Expression Signature Positive)
n=97 Participants
Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Positive)
Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
LCL161 + Paclitaxel (Gene Expression Signature Negative)
Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
Paclitaxel Only (Gene Expression Signature Negative)
Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast
Cycle 1 Day 1 (n:97)
|
5250.70 ng*hr/mL
Full Range 1113.41 • Interval 465.8 to 13379.0
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast
Cycle 4 Day 15 (n:47)
|
5522.58 ng*hr/mL
Full Range 1161.75 • Interval 1070.8 to 13745.5
|
—
|
—
|
—
|
Adverse Events
LCL161+PACLITAXEL
PACLITAXEL
Serious adverse events
| Measure |
LCL161+PACLITAXEL
n=106 participants at risk
Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
PACLITAXEL
n=103 participants at risk
Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.94%
1/106
|
0.97%
1/103
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.94%
1/106
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.94%
1/106
|
0.97%
1/103
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.94%
1/106
|
0.00%
0/103
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/106
|
0.00%
0/103
|
|
Cardiac disorders
Sinus tachycardia
|
0.94%
1/106
|
0.00%
0/103
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/106
|
0.97%
1/103
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/106
|
0.00%
0/103
|
|
Gastrointestinal disorders
Nausea
|
0.94%
1/106
|
0.00%
0/103
|
|
General disorders
Chills
|
1.9%
2/106
|
0.00%
0/103
|
|
General disorders
Feeling cold
|
0.94%
1/106
|
0.00%
0/103
|
|
General disorders
Influenza like illness
|
0.94%
1/106
|
0.00%
0/103
|
|
General disorders
Pyrexia
|
17.9%
19/106
|
0.97%
1/103
|
|
Immune system disorders
Anaphylactic reaction
|
0.94%
1/106
|
0.97%
1/103
|
|
Immune system disorders
Anaphylactic shock
|
0.94%
1/106
|
0.00%
0/103
|
|
Immune system disorders
Cytokine release syndrome
|
0.94%
1/106
|
0.00%
0/103
|
|
Immune system disorders
Drug hypersensitivity
|
1.9%
2/106
|
0.00%
0/103
|
|
Immune system disorders
Hypersensitivity
|
2.8%
3/106
|
0.97%
1/103
|
|
Infections and infestations
Atypical pneumonia
|
2.8%
3/106
|
0.97%
1/103
|
|
Infections and infestations
Febrile infection
|
0.94%
1/106
|
0.00%
0/103
|
|
Infections and infestations
Herpes zoster
|
0.94%
1/106
|
0.00%
0/103
|
|
Infections and infestations
Infection
|
0.94%
1/106
|
0.00%
0/103
|
|
Infections and infestations
Lower respiratory tract infection
|
0.94%
1/106
|
0.00%
0/103
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
3.8%
4/106
|
0.00%
0/103
|
|
Infections and infestations
Pneumonia
|
3.8%
4/106
|
0.97%
1/103
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/106
|
0.97%
1/103
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106
|
0.00%
0/103
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/106
|
0.97%
1/103
|
|
Investigations
Alanine aminotransferase increased
|
0.94%
1/106
|
0.00%
0/103
|
|
Investigations
Blood creatinine increased
|
0.94%
1/106
|
0.00%
0/103
|
|
Investigations
White blood cell count decreased
|
0.94%
1/106
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.94%
1/106
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.94%
1/106
|
0.00%
0/103
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
2/106
|
0.00%
0/103
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.94%
1/106
|
0.00%
0/103
|
|
Psychiatric disorders
Depression
|
0.94%
1/106
|
0.00%
0/103
|
|
Renal and urinary disorders
Acute kidney injury
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.94%
1/106
|
0.97%
1/103
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.4%
10/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.94%
1/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
2/106
|
0.00%
0/103
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.94%
1/106
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.94%
1/106
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
2/106
|
0.00%
0/103
|
|
Social circumstances
Immobile
|
0.94%
1/106
|
0.00%
0/103
|
|
Vascular disorders
Hypotension
|
1.9%
2/106
|
0.00%
0/103
|
Other adverse events
| Measure |
LCL161+PACLITAXEL
n=106 participants at risk
Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
PACLITAXEL
n=103 participants at risk
Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
27/106
|
12.6%
13/103
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.1%
33/106
|
8.7%
9/103
|
|
Eye disorders
Vision blurred
|
6.6%
7/106
|
0.97%
1/103
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
11/106
|
7.8%
8/103
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
7/106
|
3.9%
4/103
|
|
Gastrointestinal disorders
Constipation
|
22.6%
24/106
|
23.3%
24/103
|
|
Gastrointestinal disorders
Diarrhoea
|
71.7%
76/106
|
22.3%
23/103
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
10/106
|
2.9%
3/103
|
|
Gastrointestinal disorders
Dyspepsia
|
11.3%
12/106
|
9.7%
10/103
|
|
Gastrointestinal disorders
Nausea
|
42.5%
45/106
|
31.1%
32/103
|
|
Gastrointestinal disorders
Stomatitis
|
24.5%
26/106
|
17.5%
18/103
|
|
Gastrointestinal disorders
Vomiting
|
19.8%
21/106
|
15.5%
16/103
|
|
General disorders
Asthenia
|
15.1%
16/106
|
10.7%
11/103
|
|
General disorders
Chills
|
11.3%
12/106
|
3.9%
4/103
|
|
General disorders
Fatigue
|
45.3%
48/106
|
36.9%
38/103
|
|
General disorders
Influenza like illness
|
5.7%
6/106
|
0.00%
0/103
|
|
General disorders
Oedema peripheral
|
11.3%
12/106
|
2.9%
3/103
|
|
General disorders
Pyrexia
|
41.5%
44/106
|
8.7%
9/103
|
|
Immune system disorders
Drug hypersensitivity
|
7.5%
8/106
|
0.97%
1/103
|
|
Immune system disorders
Hypersensitivity
|
6.6%
7/106
|
5.8%
6/103
|
|
Infections and infestations
Urinary tract infection
|
9.4%
10/106
|
2.9%
3/103
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.6%
7/106
|
8.7%
9/103
|
|
Investigations
Alanine aminotransferase increased
|
14.2%
15/106
|
10.7%
11/103
|
|
Investigations
Aspartate aminotransferase increased
|
12.3%
13/106
|
7.8%
8/103
|
|
Investigations
Haemoglobin decreased
|
7.5%
8/106
|
2.9%
3/103
|
|
Investigations
Neutrophil count decreased
|
9.4%
10/106
|
1.9%
2/103
|
|
Investigations
White blood cell count decreased
|
7.5%
8/106
|
2.9%
3/103
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.3%
12/106
|
4.9%
5/103
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
6/106
|
7.8%
8/103
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.8%
21/106
|
14.6%
15/103
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
10/106
|
7.8%
8/103
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.4%
11/106
|
5.8%
6/103
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
23/106
|
17.5%
18/103
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
11/106
|
5.8%
6/103
|
|
Nervous system disorders
Dizziness
|
11.3%
12/106
|
6.8%
7/103
|
|
Nervous system disorders
Dysgeusia
|
22.6%
24/106
|
8.7%
9/103
|
|
Nervous system disorders
Headache
|
33.0%
35/106
|
17.5%
18/103
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
2/106
|
5.8%
6/103
|
|
Nervous system disorders
Neuropathy peripheral
|
12.3%
13/106
|
27.2%
28/103
|
|
Nervous system disorders
Neurotoxicity
|
10.4%
11/106
|
9.7%
10/103
|
|
Nervous system disorders
Paraesthesia
|
8.5%
9/106
|
3.9%
4/103
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.6%
25/106
|
16.5%
17/103
|
|
Psychiatric disorders
Anxiety
|
7.5%
8/106
|
7.8%
8/103
|
|
Psychiatric disorders
Insomnia
|
20.8%
22/106
|
16.5%
17/103
|
|
Reproductive system and breast disorders
Breast pain
|
8.5%
9/106
|
9.7%
10/103
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.3%
30/106
|
9.7%
10/103
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.6%
24/106
|
6.8%
7/103
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.2%
15/106
|
8.7%
9/103
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.1%
16/106
|
3.9%
4/103
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.7%
6/106
|
0.00%
0/103
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
67.9%
72/106
|
67.0%
69/103
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.4%
10/106
|
7.8%
8/103
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.7%
5/106
|
5.8%
6/103
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar erythrodysaesthesia syndrome
|
7.5%
8/106
|
2.9%
3/103
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.4%
28/106
|
8.7%
9/103
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.5%
44/106
|
26.2%
27/103
|
|
Vascular disorders
Flushing
|
5.7%
6/106
|
6.8%
7/103
|
|
Vascular disorders
Hot flush
|
16.0%
17/106
|
14.6%
15/103
|
|
Vascular disorders
Hypertension
|
2.8%
3/106
|
5.8%
6/103
|
Additional Information
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER