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BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379247
Recruitment Status : Active, not recruiting
First Posted : March 4, 2015
Results First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Priyanka Sharma, University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: BYL-719 (alpelisib)
Drug: Nab-paclitaxel
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719 (Alpelisib) (300mg)+Nab-paclitaxel Dose Level 3 BYL-719 (Alpelisib) (350mg)+Nab-paclitaxel BYL-719 (Alpelisib) Dose Expansion
Hide Arm/Group Description

BYL-719 (alpelisib): 250mg daily on day 1-28

Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)

BYL-719 (alpelisib): Oral PI3K inhibitor

Nab-paclitaxel: IV taxane

BYL-719 (alpelisib): 300mg by mouth daily on day 1-28 of each 28 day cycle

Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)

BYL-719 (alpelisib): Oral PI3K inhibitor

Nab-paclitaxel: IV taxane

BYL-719 (alpelisib): 350mg by mouth daily on day 1-28 of each 28 day cycle

Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)

BYL-719 (alpelisib): Oral PI3K inhibitor

Nab-paclitaxel: IV taxane

BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle

Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day)

BYL-719 (alpelisib): Oral PI3K inhibitor

Nab-paclitaxel: IV taxane

Period Title: Overall Study
Started 3 3 7 30
Completed 3 3 7 30
Not Completed 0 0 0 0
Arm/Group Title Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel BYL-719/Alpelisib Dose Expansion Total
Hide Arm/Group Description BYL-719 (alpelisib): 250mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): 300mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): 350mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane Total of all reporting groups
Overall Number of Baseline Participants 3 3 7 30 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
61
(41 to 65)
61
(51 to 62)
59
(52 to 68)
54
(34 to 72)
55
(34 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
Female
3
 100.0%
3
 100.0%
7
 100.0%
30
 100.0%
43
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
3
 100.0%
3
 100.0%
7
 100.0%
30
 100.0%
43
 100.0%
Metastatic disease subtype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Estrogen receptor and/or progesterone receptor positive Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
1
  33.3%
2
  66.7%
4
  57.1%
23
  76.7%
30
  69.8%
Triple-negative Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
2
  66.7%
1
  33.3%
3
  42.9%
7
  23.3%
13
  30.2%
[1]
Measure Description: Estrogen receptor and progesterone receptor positivity was defined as ≥10% by immunohistochemistry. HER2 positivity was defined per 2013 ASCO/CAP guidelines (Wolff et al, J Clin Oncol 2013;31(31):3997-4013. Triple negativity was defined as estrogen receptor negative, progesterone receptor negative, and HER2 negative.
Measurable disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
3
 100.0%
3
 100.0%
7
 100.0%
30
 100.0%
43
 100.0%
[1]
Measure Description: Presence of measurable disease according to RECIST version 1.1
Visceral disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Present Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
3
 100.0%
3
 100.0%
6
  85.7%
24
  80.0%
36
  83.7%
Absent Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
0
   0.0%
0
   0.0%
1
  14.3%
6
  20.0%
7
  16.3%
[1]
Measure Description: Presence of at least one visceral metastatic site
Prior lines of chemotherapy for metastatic disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
0
   0.0%
1
  33.3%
2
  28.6%
7
  23.3%
10
  23.3%
1 Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
3
 100.0%
2
  66.7%
3
  42.9%
12
  40.0%
20
  46.5%
≥2 Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
0
   0.0%
0
   0.0%
2
  28.6%
11
  36.7%
13
  30.2%
[1]
Measure Description: Number of prior lines of chemotherapy for metastatic disease.
Prior taxane   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Neoadjuvant or adjuvant Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
2
  66.7%
2
  66.7%
5
  71.4%
17
  56.7%
26
  60.5%
Metastatic only Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
1
  33.3%
0
   0.0%
0
   0.0%
6
  20.0%
7
  16.3%
Neoadjuvant or adjuvant AND metastatic Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
  10.0%
3
   7.0%
None Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
0
   0.0%
1
  33.3%
2
  28.6%
4
  13.3%
7
  16.3%
[1]
Measure Description: Prior receipt of a taxane, and in what treatment setting(s) a taxane was received.
Prior CDK4/6 inhibitor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
1
  33.3%
0
   0.0%
0
   0.0%
11
  36.7%
12
  27.9%
No Number Analyzed 3 participants 3 participants 7 participants 30 participants 43 participants
2
  66.7%
3
 100.0%
7
 100.0%
19
  63.3%
31
  72.1%
[1]
Measure Description: Prior receipt of any CDK4/6 inhibitor
1.Primary Outcome
Title Phase I: Recommended Phase II Dose (RP2D) of BYL-719 (Alpelisib) + Nab-paclitaxel to be Used in Combination to Treat Advanced HER2-negative Breast Cancer
Hide Description Phase I was a 3+3 dose escalation design (three dose levels of alpelisib: 250mg, 300mg, and 350mg orally once daily, continuous dosing) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which <1/6 subjects experienced a DLT.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I
Hide Arm/Group Description:
All patients in phase I, across all three dose levels of BYL-719 (alpelisib) + nab-paclitaxel
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: mg
350
2.Primary Outcome
Title Phase II: Overall Response Rate (ORR) of Subjects Treated at the Recommended Phase II Dose (RP2D)
Hide Description ORR includes complete response (CR) plus partial response (PR). As evaluated per RECIST version 1.1.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Treated at the RP2D
Hide Arm/Group Description:
Participants who were treated at the RP2D (350 mg BYL-719/alpelisib + 100 mg/m2 nab-paclitaxel) in either phase I or phase II.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
17
  51.5%
3.Secondary Outcome
Title Clinical Benefit Rate (CBR) at 16 Weeks of Study Treatment
Hide Description CBR includes complete response (CR), partial response (PR), plus stable disease (SD) ≥16 weeks. As evaluated per RECIST version 1.1.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol the endpoint of CBR at 16 weeks is to be reported for all participants in phase I and phase II who were evaluable for response, thus participants from all assigned dose levels are combined for this analysis.
Arm/Group Title All Evaluable Participants
Hide Arm/Group Description:
All participants in phase I and phase II who were evaluable for response (i.e. received at least one cycle of study treatment)
Overall Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
35
  83.3%
4.Secondary Outcome
Title Pharmacokinetics of BYL-719 (Alpelisib) When Administered With Nab-paclitaxel
Hide Description Area under the curve (AUC): sampling pre-dose and 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-alpelisib dose
Time Frame In cycle 1 day 1, from prior to alpelisib dosing through 8 hours after alpelisib dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic measures were assessed only among participants in phase I.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
Hide Arm/Group Description:
Participants assigned to dose level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel
Participants assigned to Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel
Participants in phase I assigned to dose level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel
Overall Number of Participants Analyzed 3 3 7
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
6846  (3410) 12436  (6174) 13359  (5798)
5.Secondary Outcome
Title Pharmacokinetics of (Total) Nab-paclitaxel When Administered With BYL-719 (Alpelisib)
Hide Description Area under the curve (AUC): sampling pre-dose and 1.5, 2, 2.5, 3, 3.5, 4, and 6 hours post-alpelisib dose
Time Frame In cycle 1 day 1, from prior to alpelisib dosing through 8 hours after alpelisib dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic measures were assessed only among participants in phase I. One phase I participant assigned to the 350 mg BYL-719 (alpelisib) dose level did not have an end-of-infusion sample for paclitaxel measurement. Data are based on 12 participants.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3
Hide Arm/Group Description:
Participants assigned to dose level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel
Participants assigned to dose level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel
Participants in phase I assigned to dose level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel
Overall Number of Participants Analyzed 3 3 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
8488  (1537) 9938  (1735) 6979  (2492)
6.Secondary Outcome
Title Progression-free Survival (PFS) and Overall Survival (OS)
Hide Description PFS was defined as the time in months from the date of enrollment to the date of progression or death, whichever was earlier. OS was defined as the time in months from the date of enrollment to death as a result of any cause. Survival curves were assessed by the Kaplan-Meier method.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol the endpoints of PFS and OS are to be reported for all participants in phase I and phase II who were evaluable for response, thus participants from all assigned dose levels are combined for this analysis.
Arm/Group Title All Evaluable Participants
Hide Arm/Group Description:
All participants in phase I and phase II who were evaluable for response (i.e. received at least one cycle of study treatment)
Overall Number of Participants Analyzed 42
Median (95% Confidence Interval)
Unit of Measure: months
Progression-free survival
8.7
(5.5 to 11.9)
Overall survival
18.5
(9.6 to 27.4)
7.Other Pre-specified Outcome
Title Correlation of PIK3CA Mutation With Clinical Benefit Rate
Hide Description Comparison of clinical benefit rate between participants with and without PIK3CA mutation in tumor tissue and/or circulating tumor DNA. Clinical benefit rate includes complete response (CR), partial response (PR), plus stable disease (SD) ≥16 weeks, as evaluated per RECIST version 1.1. Tumor DNA was isolated from archived formalin-fixed, paraffin-embedded tumor tissue (primary or metastatic site) and subjected to next-generation sequencing for assessment of PIK3CA mutation using ONCOReveal Multi-Cancer Panel (Pillar Biosciences). Circulating tumor DNA was isolated from pre-treatment plasma samples and subjected to next-generation sequencing for assessment of PIK3CA mutation using FoundationOne CDx testing or ONCOReveal Multi-Cancer Panel.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Among 42 participants evaluable for response, 17 had PIK3CA mutation in tumor tissue and/or circulating tumor DNA, while 25 did not. Clinical benefit rate was assessed among participants with PIK3CA mutation separately from participants without PIK3CA mutation for the purpose of correlating clinical benefit rate with PIK3CA mutation status. Per protocol the analysis is reported for all participants evaluable for response, thus participants from all dose levels are combined for this analysis.
Arm/Group Title All Evaluable Participants
Hide Arm/Group Description:
All participants in phase I and phase II who were evaluable for response (i.e. received at least one cycle of study treatment)
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
PIK3CA mutation present Number Analyzed 17 participants
17
PIK3CA mutation absent Number Analyzed 25 participants
17
Time Frame For each participant, treatment-related adverse events were collected from start of study treatment until 30 days after the participant's last dose of study treatment, assessed up to 174 weeks, whichever came first. All-cause mortality was collected from start of study treatment through October 16, 2019 (data cutoff date).
Adverse Event Reporting Description Adverse events (serious and non-serious) of all grades, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
 
Arm/Group Title Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel BYL-719 (Alpelisib) Dose Expansion
Hide Arm/Group Description BYL-719 (alpelisib): 250mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): 300mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): 350mg daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) BYL-719 (alpelisib): Oral PI3K inhibitor Nab-paclitaxel: IV taxane
All-Cause Mortality
Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel BYL-719 (Alpelisib) Dose Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   5/7 (71.43%)   19/30 (63.33%) 
Hide Serious Adverse Events
Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel BYL-719 (Alpelisib) Dose Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/7 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1 BYL-719/Alpelisib (250mg)+Nab-paclitaxel Dose Level 2 BYL-719/Alpelisib (300mg)+Nab-paclitaxel Dose Level 3 BYL-719/Alpelisib (350mg)+Nab-paclitaxel BYL-719 (Alpelisib) Dose Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   7/7 (100.00%)   28/30 (93.33%) 
Blood and lymphatic system disorders         
Anemia   3/3 (100.00%)  0/3 (0.00%)  3/7 (42.86%)  15/30 (50.00%) 
Neutropenia   2/3 (66.67%)  1/3 (33.33%)  3/7 (42.86%)  14/30 (46.67%) 
Decreased lymphocyte count   0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  1/30 (3.33%) 
Eye disorders         
Watering eyes   0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  3/30 (10.00%) 
Blurred vision   0/3 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/30 (10.00%) 
Dry eyes   0/3 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/30 (10.00%) 
Gastrointestinal disorders         
Diarrhea   2/3 (66.67%)  3/3 (100.00%)  6/7 (85.71%)  19/30 (63.33%) 
Nausea   3/3 (100.00%)  2/3 (66.67%)  3/7 (42.86%)  20/30 (66.67%) 
Mucositis   1/3 (33.33%)  2/3 (66.67%)  4/7 (57.14%)  14/30 (46.67%) 
Vomiting   0/3 (0.00%)  1/3 (33.33%)  3/7 (42.86%)  7/30 (23.33%) 
Dyspepsia   1/3 (33.33%)  0/3 (0.00%)  0/7 (0.00%)  7/30 (23.33%) 
Flatulence   0/3 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  4/30 (13.33%) 
Gastrointestinal - other  [1]  0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  1/30 (3.33%) 
General disorders         
Fatigue   1/3 (33.33%)  3/3 (100.00%)  5/7 (71.43%)  18/30 (60.00%) 
Edema   0/3 (0.00%)  2/3 (66.67%)  3/7 (42.86%)  7/30 (23.33%) 
Hepatobiliary disorders         
Liver enzyme increase   1/3 (33.33%)  1/3 (33.33%)  1/7 (14.29%)  6/30 (20.00%) 
Infections and infestations         
Infection   0/3 (0.00%)  3/3 (100.00%)  2/7 (28.57%)  8/30 (26.67%) 
Fever   0/3 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/30 (10.00%) 
Investigations         
Electrolyte imbalance   2/3 (66.67%)  3/3 (100.00%)  5/7 (71.43%)  12/30 (40.00%) 
Metabolism and nutrition disorders         
Hyperglycemia   1/3 (33.33%)  3/3 (100.00%)  7/7 (100.00%)  19/30 (63.33%) 
Anorexia   1/3 (33.33%)  2/3 (66.67%)  3/7 (42.86%)  16/30 (53.33%) 
Weight loss   0/3 (0.00%)  1/3 (33.33%)  2/7 (28.57%)  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders         
Myalgia   0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  8/30 (26.67%) 
Arthralgia   0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  6/30 (20.00%) 
Musculoskeletal  [2]  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  6/30 (20.00%) 
Nervous system disorders         
Peripheral neuropathy   2/3 (66.67%)  3/3 (100.00%)  3/7 (42.86%)  17/30 (56.67%) 
Dysgeusia   0/3 (0.00%)  1/3 (33.33%)  2/7 (28.57%)  16/30 (53.33%) 
Dizziness   0/3 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/30 (10.00%) 
Gait disturbance   0/3 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  1/30 (3.33%) 
Headache   0/3 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  1/30 (3.33%) 
Renal and urinary disorders         
Creatinine imbalance   0/3 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  3/30 (10.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea   1/3 (33.33%)  0/3 (0.00%)  0/7 (0.00%)  7/30 (23.33%) 
Cough   1/3 (33.33%)  0/3 (0.00%)  1/7 (14.29%)  5/30 (16.67%) 
Pneumonitis   0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  2/30 (6.67%) 
Skin and subcutaneous tissue disorders         
Rash   0/3 (0.00%)  1/3 (33.33%)  4/7 (57.14%)  14/30 (46.67%) 
Nail changes   0/3 (0.00%)  1/3 (33.33%)  2/7 (28.57%)  7/30 (23.33%) 
Alopecia   0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  6/30 (20.00%) 
Dry skin/mouth   0/3 (0.00%)  1/3 (33.33%)  2/7 (28.57%)  5/30 (16.67%) 
Indicates events were collected by systematic assessment
[1]
Grade 2 colitis (n=1); grade 1 stomach tightness (n=1); and grade 1 unspecified gastrointestinal disorder (n=1).
[2]
Grade 3 generalized muscle weakness (n=1); grade 2 muscle weakness lower limb (n=2); grade 1 events (n=1 each): muscle weakness lower limb, left arm pain, generalized muscle weakness, and toe pain.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Priyanka Sharma
Organization: University of Kansas Medical Center
Phone: 9135886079
EMail: psharma2@kumc.edu
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Responsible Party: Priyanka Sharma, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02379247    
Other Study ID Numbers: CBYL719XUS06T
First Submitted: January 30, 2015
First Posted: March 4, 2015
Results First Submitted: May 7, 2021
Results First Posted: September 28, 2021
Last Update Posted: September 28, 2021