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Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-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: NCT01964924
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor Negative
HER2/Neu Negative
Invasive Breast Carcinoma
Progesterone Receptor Negative
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma
Interventions Drug: Akt Inhibitor GSK2141795
Other: Laboratory Biomarker Analysis
Drug: Trametinib
Enrollment 37
Recruitment Details  
Pre-assignment Details Patients on Part 1: trametinib monotherapy until progression and then will continue on to Part 2: trametinib combined with GSK2141795.
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression in Part 1 continue to Part 2.

PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Period Title: Trametinib Monotherapy
Started 37 0
Completed 18 0
Not Completed 19 0
Reason Not Completed
Progression             19             0
Period Title: Trametinib + GSK2141
Started [1] 0 19 [2]
Completed 0 19
Not Completed 0 0
[1]
Participants who completed Part 1 were not eligible for Part 2
[2]
Progressed in Part 1 and therefore initiated combination treatment in Part 2
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795)
Hide Arm/Group Description

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
57
(35 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
37
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
37
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  10.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   5.4%
White
31
  83.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795)
Hide Arm/Group Description:

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.4%
2.Secondary Outcome
Title Clinical Benefit Rate (CBR = CR+PR+Stable Disease [SD])
Hide Description The clinical benefit rate (CR+PR+SD) will be reported for patients after Part 1 and after Part 2.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:
PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37 19
Measure Type: Count of Participants
Unit of Measure: Participants
8
  21.6%
6
  31.6%
3.Secondary Outcome
Title Duration of Objective Response
Hide Description Summary statistics of duration of response for patients with objective response
Time Frame up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:
PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: days of response
162.75  (149.26) 87.00  (62.86)
4.Secondary Outcome
Title Incidence of Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment
Hide Description Incidence of adverse events for patients that are classified as either possibly, probably, or definitely related to study treatment graded by National Cancer Institute (NCI) CTCAE v4.0
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:
PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.
PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 19
Measure Type: Number
Unit of Measure: number of adverse events
227 204
5.Secondary Outcome
Title Incidence of Severe (Grade 3+) Adverse Events or Toxicities Graded Per NCI CTCAE Version 4.0
Hide Description NCI CommonTerminology Criteria for Adverse Events (CTCAE) version 4.0 was utilized for grading incidence of toxicities (grade 3+).
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:
PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.
PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 37 19
Measure Type: Number
Unit of Measure: number of adverse events
68 29
6.Secondary Outcome
Title Overall Survival
Hide Description The Kaplan-Meier method will be used to estimate overall survival distribution.
Time Frame Start date of the treatment to the date of the event (i.e., death) or the date of last follow-up to evaluate that event, assessed up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
overall survival analyzed for all patients regardless of (part 1 only) or (part 1 and 2) participation
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795)
Hide Arm/Group Description:

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: weeks
43.143
(33.0 to 99.286)
7.Secondary Outcome
Title Progression-free Survival
Hide Description The Kaplan-Meier method will be used to estimate progression-free survival distribution.
Time Frame The duration of time from start of treatment to time of progression or death, whichever comes first, assessed up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:
PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37 19
Median (95% Confidence Interval)
Unit of Measure: weeks
7.71
(4.43 to 8.29)
7.86
(5.86 to 13.86)
8.Secondary Outcome
Title Proportion of Patients Who go Off Treatment Due to Adverse Reactions
Hide Description The proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial was captured. These tolerability measures were assessed within each of the treatment parts independently. All patients who have received at least one dose of any of the therapeutic agents was evaluable for toxicity and tolerability.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37 19
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.8%
0
   0.0%
9.Secondary Outcome
Title Proportion of Patients Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial
Hide Description [Not Specified]
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial was in Part I
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.4%
0
10.Secondary Outcome
Title Tolerability of the Regimen Defined as the Number of Patients Who Required Dose Modifications and/or Dose Delays
Hide Description [Not Specified]
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description:

PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.

PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

PART 2: Patients who experience disease progression in Part 1 continue to Part 2. Patients receive trametinib and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor GSK2141795: Given PO

Laboratory Biomarker Analysis: Correlative studies

Trametinib: Given PO

Overall Number of Participants Analyzed 37 19
Measure Type: Count of Participants
Unit of Measure: Participants
35
  94.6%
0
   0.0%
11.Other Pre-specified Outcome
Title Predictive Value of PTEN and Other Biomarkers on Patient Outcome (Survival, ORR, and CBR)
Hide Description [Not Specified]
Time Frame At time of disease progression, assessed up to 52 weeks
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Protein Intensity Fold-change Ratios Assessed by Reverse Phase Protein Assay Intensity Values
Hide Description Ratios between tumors sampled prior to initiating trametinib single agent treatment and at time of progression (TOP) on either single agent trametinib or the combination (TOP/pre-treat ratio), will be calculated. These ratios will be median-centered and clustered using Cluster 2.0 software. Student's t-test for differences between average protein intensity ratios at these intervals will be calculated using Microsoft Excel by grouping all the ratios for individual clusters.
Time Frame Up to 52 weeks
Outcome Measure Data Not Reported
Time Frame Up to 1 year patients will be evaluated for toxicities from the time of their first treatment until they are off study.
Adverse Event Reporting Description Adverse Event grading was done using NCI CTCAE version 4.0
 
Arm/Group Title Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Hide Arm/Group Description PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Affected / at Risk (%) Affected / at Risk (%)
Total   13/37 (35.14%)      12/19 (63.16%)    
Hide Serious Adverse Events
Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/37 (81.08%)      15/19 (78.95%)    
Blood and lymphatic system disorders     
Anemia  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Leukocytosis  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Cardiac disorders     
Cardiac arrest  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  0/37 (0.00%)  0 2/19 (10.53%)  2
Dysphagia  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Enterocolitis  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Vomiting  1  0/37 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Death NOS  1  1/37 (2.70%)  1 4/19 (21.05%)  4
Edema face  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Edema limbs  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Fever  1  1/37 (2.70%)  1 1/19 (5.26%)  1
General disorders and administration site conditions - Other, specify  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Infections and infestations     
Infections and infestations - Other, specify  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Sepsis  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Skin infection  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Investigations     
Alkaline phosphatase increased  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Hypoalbuminemia  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Hypocalcemia  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Hypoglycemia  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  8/37 (21.62%)  8 3/19 (15.79%)  3
Nervous system disorders     
Hypoglossal nerve disorder  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Syncope  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
Renal and urinary disorders - Other, specify  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Pleural effusion  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Pneumonitis  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Vascular disorders     
Hypertension  1  1/37 (2.70%)  1 0/19 (0.00%)  0
Thromboembolic event  1  1/37 (2.70%)  1 0/19 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 1: Treatment (Trametinib, Akt Inhibitor GSK2141795) PART 2:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/37 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  7/37 (18.92%)  7 8/19 (42.11%)  8
Cardiac disorders     
Heart failure  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Left ventricular systolic dysfunction  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Sinus tachycardia  1  3/37 (8.11%)  3 0/19 (0.00%)  0
Ventricular tachycardia  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Endocrine disorders     
Hyperthyroidism  1  2/37 (5.41%)  2 1/19 (5.26%)  1
Hypothyroidism  1  1/37 (2.70%)  1 2/19 (10.53%)  2
Eye disorders     
Blurred vision  1  1/37 (2.70%)  1 2/19 (10.53%)  2
Gastrointestinal disorders     
Abdominal distension  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Abdominal pain  1  3/37 (8.11%)  3 0/19 (0.00%)  0
Colitis  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Constipation  1  5/37 (13.51%)  5 0/19 (0.00%)  0
Diarrhea  1  11/37 (29.73%)  11 16/19 (84.21%)  16
Dry mouth  1  4/37 (10.81%)  4 1/19 (5.26%)  1
Dyspepsia  1  4/37 (10.81%)  4 0/19 (0.00%)  0
Dysphagia  1  2/37 (5.41%)  2 5/19 (26.32%)  5
Esophageal pain  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Gastroesophageal reflux disease  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders - Other, specify  1  2/37 (5.41%)  2 2/19 (10.53%)  2
Mucositis oral  1  4/37 (10.81%)  4 12/19 (63.16%)  13
Nausea  1  12/37 (32.43%)  12 5/19 (26.32%)  6
Vomiting  1  6/37 (16.22%)  6 3/19 (15.79%)  3
General disorders     
Edema face  1  4/37 (10.81%)  4 1/19 (5.26%)  1
Edema limbs  1  11/37 (29.73%)  11 4/19 (21.05%)  4
Edema trunk  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Facial pain  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Fatigue  1  11/37 (29.73%)  11 6/19 (31.58%)  6
Fever  1  3/37 (8.11%)  3 0/19 (0.00%)  0
Flu like symptoms  1  2/37 (5.41%)  2 1/19 (5.26%)  1
Localized edema  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Neck edema  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Non-cardiac chest pain  1  2/37 (5.41%)  2 3/19 (15.79%)  3
Pain  1  4/37 (10.81%)  4 2/19 (10.53%)  2
Infections and infestations     
Infections and infestations - Other, specify  1  1/37 (2.70%)  1 3/19 (15.79%)  4
Paronychia  1  1/37 (2.70%)  1 2/19 (10.53%)  2
Skin infection  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Urinary tract infection  1  2/37 (5.41%)  2 1/19 (5.26%)  1
Injury, poisoning and procedural complications     
Bruising  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Fall  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Vascular access complication  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Investigations     
Alanine aminotransferase increased  1  7/37 (18.92%)  7 2/19 (10.53%)  2
Alkaline phosphatase increased  1  6/37 (16.22%)  6 3/19 (15.79%)  3
Aspartate aminotransferase increased  1  13/37 (35.14%)  13 4/19 (21.05%)  4
Creatinine increased  1  4/37 (10.81%)  4 3/19 (15.79%)  3
Ejection fraction decreased  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Electrocardiogram QT corrected interval prolonged  1  0/37 (0.00%)  0 2/19 (10.53%)  2
INR increased  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Investigations - Other, specify  1  0/37 (0.00%)  0 2/19 (10.53%)  3
Lymphocyte count decreased  1  6/37 (16.22%)  6 4/19 (21.05%)  4
Neutrophil count decreased  1  1/37 (2.70%)  1 2/19 (10.53%)  3
Platelet count decreased  1  7/37 (18.92%)  7 3/19 (15.79%)  3
Weight gain  1  3/37 (8.11%)  3 1/19 (5.26%)  1
Weight loss  1  1/37 (2.70%)  1 3/19 (15.79%)  4
White blood cell decreased  1  5/37 (13.51%)  5 6/19 (31.58%)  7
Metabolism and nutrition disorders     
Anorexia  1  5/37 (13.51%)  5 2/19 (10.53%)  2
Dehydration  1  1/37 (2.70%)  1 5/19 (26.32%)  5
Hypercalcemia  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Hyperglycemia  1  7/37 (18.92%)  7 6/19 (31.58%)  8
Hypoalbuminemia  1  9/37 (24.32%)  9 7/19 (36.84%)  8
Hypocalcemia  1  3/37 (8.11%)  3 4/19 (21.05%)  5
Hypoglycemia  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Hypokalemia  1  3/37 (8.11%)  3 2/19 (10.53%)  6
Hypomagnesemia  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Hyponatremia  1  3/37 (8.11%)  3 1/19 (5.26%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Back pain  1  3/37 (8.11%)  3 4/19 (21.05%)  4
Flank pain  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Generalized muscle weakness  1  3/37 (8.11%)  3 2/19 (10.53%)  2
Neck pain  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Pain in extremity  1  4/37 (10.81%)  4 2/19 (10.53%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps-Other  1  1/37 (2.70%)  1 2/19 (10.53%)  2
Tumor pain  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Nervous system disorders     
Dizziness  1  3/37 (8.11%)  3 1/19 (5.26%)  1
Dysgeusia  1  0/37 (0.00%)  0 2/19 (10.53%)  2
Dysphasia  1  0/37 (0.00%)  0 2/19 (10.53%)  2
Headache  1  4/37 (10.81%)  4 0/19 (0.00%)  0
Movements involuntary  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Peripheral motor neuropathy  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Peripheral sensory neuropathy  1  5/37 (13.51%)  5 4/19 (21.05%)  4
Presyncope  1  0/37 (0.00%)  0 1/19 (5.26%)  2
Psychiatric disorders     
Anxiety  1  4/37 (10.81%)  4 0/19 (0.00%)  0
Depression  1  4/37 (10.81%)  4 0/19 (0.00%)  0
Insomnia  1  2/37 (5.41%)  2 2/19 (10.53%)  2
Renal and urinary disorders     
Hematuria  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Urinary frequency  1  2/37 (5.41%)  2 2/19 (10.53%)  2
Reproductive system and breast disorders     
Breast pain  1  1/37 (2.70%)  1 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/37 (8.11%)  3 2/19 (10.53%)  2
Dyspnea  1  9/37 (24.32%)  9 8/19 (42.11%)  8
Epistaxis  1  1/37 (2.70%)  1 3/19 (15.79%)  3
Hoarseness  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Hypoxia  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Nasal congestion  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Pleural effusion  1  5/37 (13.51%)  5 0/19 (0.00%)  0
Pneumonitis  1  0/37 (0.00%)  0 3/19 (15.79%)  3
Sore throat  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Voice alteration  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  3/37 (8.11%)  3 1/19 (5.26%)  1
Dry skin  1  5/37 (13.51%)  5 4/19 (21.05%)  4
Nail ridging  1  2/37 (5.41%)  2 0/19 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Pruritus  1  6/37 (16.22%)  6 3/19 (15.79%)  5
Rash acneiform  1  10/37 (27.03%)  10 3/19 (15.79%)  5
Rash maculo-papular  1  6/37 (16.22%)  6 3/19 (15.79%)  3
Skin and subcutaneous tissue disorders - Other, specify  1  4/37 (10.81%)  4 3/19 (15.79%)  3
Vascular disorders     
Hypertension  1  5/37 (13.51%)  5 7/19 (36.84%)  9
Hypotension  1  0/37 (0.00%)  0 1/19 (5.26%)  1
Lymphedema  1  5/37 (13.51%)  5 2/19 (10.53%)  2
Thromboembolic event  1  0/37 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Bhuvaneswari Ramaswamy
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8858
EMail: Bhuvaneswari.Ramaswamy@osumc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01964924    
Other Study ID Numbers: NCI-2013-01895
NCI-2013-01895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2013C0069
OSU 13117
9455 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
9455 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
UM1CA186712 ( U.S. NIH Grant/Contract )
UM1CA186716 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: December 17, 2018
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019