We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma

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: NCT02352831
Recruitment Status : Terminated (Insufficient funding and drug supply from manufacturer)
First Posted : February 2, 2015
Results First Posted : December 17, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Cancer
Cancer of Pancreas
Cancer of the Pancreas
Pancreas Cancer
Interventions Drug: Tosedostat
Drug: Capecitabine
Procedure: Fresh tissue biopsy
Enrollment 16
Recruitment Details The study opened to participant enrollment on 08/31/2015 and closed to participant enrollment on 12/22/2017.
Pre-assignment Details  
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Period Title: Overall Study
Started 6 10
Completed 6 10
Not Completed 0 0
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine) Total
Hide Arm/Group Description
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
 Total of all reporting groups
Overall Number of Baseline Participants 6 10 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 10 participants 16 participants
60.5
(42 to 73)
69.5
(51 to 76)
66
(42 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 10 participants 16 participants
Female
3
  50.0%
6
  60.0%
9
  56.3%
Male
3
  50.0%
4
  40.0%
7
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 10 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
10
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 10 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  10.0%
1
   6.3%
White
6
 100.0%
9
  90.0%
15
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 10 participants 16 participants
6 10 16
Baseline CA19-9  
Mean (Full Range)
Unit of measure:  U/mL
Number Analyzed 6 participants 10 participants 16 participants
331.22
(1.00 to 1697.90)
2061.73
(19.70 to 8803.00)
1255
(1.00 to 8803.00)
1.Primary Outcome
Title Phase I Only: Recommended Phase II Dose of Tosedostat
Hide Description

The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. If 0 or 1 of 6 patients in Dose Level 1 experience DLT during the first cycle, Dose Level 1 will be presumed to be the RP2D.

DLTs are followed through completion of the first cycle.
Time Frame Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is for Phase I participants only.
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 0
Measure Type: Number
Unit of Measure: mg daily
120
2.Primary Outcome
Title Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
Hide Description

  • Possibly/probably/definitely related to study treatment in 1st cycle (cyc)

    *Grade (Gr) 4 neutropenia >7 day, Febrile neutropenia of any duration with temperature ≥ 38.5 °C, Gr 4 anemia requires transfusion therapy on more than 2 occasions in 7 days, Gr 4 thrombocytopenia

  • Possibly/probably/definitely related gr. 3/4 non-hematologic toxicity that occurs 1st cyc with the following EXCEPTIONS:

    • Gr 3 nausea/vomiting/diarrhea/anorexia <72 hours that returns to Gr 1 prior to the start of cyc 2, Gr 3 hand-foot syndrome will only be considered a DLT for patients who have received 1 week of supportive care treatment with no improvement, Gr 3 fatigue that returns to Gr 1 prior to the start of cyc 2, Gr 3 flu-like symptoms <72 hours that returns to Gr 1 prior to start of cyc 2, Gr 3 arthralgia or myalgias <72 hours that return to Gr 1 prior to the start of cyc 2, Gr 3 potassium/phosphorus/magnesium that is asymptomatic or of non-clinical significance <72 hours, Gr 3 hypoalbuminemia
Time Frame Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is for Phase I participants only.
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
3.Primary Outcome
Title Progression-free Survival (PFS) Rate
Hide Description
  • PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

  • Progressive disease (PD)

    • Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
    • Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine) Phase I and Phase II Combined
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 10 16
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
8
  80.0%
11
  68.8%
4.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description
  • ORR = Complete response + partial response

  • Target lesions

    • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
    • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  • Non target lesions *Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Time Frame Up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Time-to-progression (TTP)
Hide Description

-Progressive disease (PD)

  • Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
  • Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 10
Median (Full Range)
Unit of Measure: days
210.50
(44.00 to 681.00)
94.50
(42.00 to 250.00)
6.Secondary Outcome
Title Overall Survival Rate (OS)
Hide Description [Not Specified]
Time Frame Up to 1 year from completion of treatment (median treatment length 81.50 days (28.00-346.00)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine) Phase I and Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
Overall Number of Participants Analyzed 6 10 16
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
2
  20.0%
5
  31.3%
7.Secondary Outcome
Title Number of Participants With a CA19-9 Response
Hide Description
  • CA19-9 is a tumor marker that is used in the management of pancreatic cancer. Rising CA19-9 levels may mean the tumor is growing and decreasing CA19-9 levels may mean the tumor is shrinking or the amount of cancer in the body is decreasing
  • A CA19-9 response means that the tumor marker has decreased over baseline (before treatment started) levels
Time Frame Completion of treatment (median treatment length 81.50 days (28.00-346.00)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description:
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Overall Number of Participants Analyzed 6 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
10
 100.0%
Time Frame Adverse events and all-cause mortality were collected from baseline through 30 days after treatment ended.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Hide Arm/Group Description
  • The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.
  • Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.
  • Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
  • Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle
  • Capecitabine by mouth BID Days 1-14 of each 21-day cycle
  • Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
All-Cause Mortality
Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   1/10 (10.00%) 
Hide Serious Adverse Events
Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/10 (30.00%) 
Cardiac disorders     
Acute coronary syndrome † 1  1/6 (16.67%)  0/10 (0.00%) 
Atrial fibrillation † 1  0/6 (0.00%)  1/10 (10.00%) 
Pericardial effusion † 1  0/6 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Colon obstruction † 1  1/6 (16.67%)  0/10 (0.00%) 
Gastric perforation † 1  0/6 (0.00%)  1/10 (10.00%) 
Infections and infestations     
Pneumonia † 1  0/6 (0.00%)  1/10 (10.00%) 
Sepsis † 1  1/6 (16.67%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  0/6 (0.00%)  1/10 (10.00%) 
Vascular disorders     
Superficial thrombephemelebitis † 1  0/6 (0.00%)  1/10 (10.00%) 
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 0%
Phase I (Tosedostat + Capecitabine) Phase II (Tosedostat + Capecitabine)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anemia † 1  1/6 (16.67%)  2/10 (20.00%) 
Eye disorders     
Blurred vision † 1  0/6 (0.00%)  2/10 (20.00%) 
Dry eye † 1  0/6 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  0/6 (0.00%)  3/10 (30.00%) 
Constipation † 1  1/6 (16.67%)  0/10 (0.00%) 
Diarrhea † 1  2/6 (33.33%)  5/10 (50.00%) 
Dyspepsia † 1  1/6 (16.67%)  3/10 (30.00%) 
Dysphagia † 1  1/6 (16.67%)  0/10 (0.00%) 
Flatulence † 1  1/6 (16.67%)  0/10 (0.00%) 
Mucositis-oral † 1  1/6 (16.67%)  1/10 (10.00%) 
Nausea † 1  2/6 (33.33%)  1/10 (10.00%) 
Pancreatitis † 1  0/6 (0.00%)  1/10 (10.00%) 
Stomach pain † 1  3/6 (50.00%)  0/10 (0.00%) 
Vomiting † 1  1/6 (16.67%)  0/10 (0.00%) 
General disorders     
Chills † 1  1/6 (16.67%)  0/10 (0.00%) 
Edema limbs † 1  2/6 (33.33%)  3/10 (30.00%) 
Fatigue † 1  3/6 (50.00%)  1/10 (10.00%) 
Fever † 1  1/6 (16.67%)  1/10 (10.00%) 
Pain † 1  1/6 (16.67%)  0/10 (0.00%) 
Sensation to cold † 1  1/6 (16.67%)  0/10 (0.00%) 
Infections and infestations     
Nail infection † 1  1/6 (16.67%)  0/10 (0.00%) 
Toe infection † 1  1/6 (16.67%)  0/10 (0.00%) 
Investigations     
Alkaline phosphatase † 1  0/6 (0.00%)  4/10 (40.00%) 
Blood bilirubin increased † 1  0/6 (0.00%)  1/10 (10.00%) 
Creatinine increase † 1  0/6 (0.00%)  1/10 (10.00%) 
Ejection fraction decreased † 1  0/6 (0.00%)  4/10 (40.00%) 
Hemoglobin decrease † 1  6/6 (100.00%)  6/10 (60.00%) 
Hypocalcemia † 1  0/6 (0.00%)  2/10 (20.00%) 
Increased amylase † 1  0/6 (0.00%)  1/10 (10.00%) 
Increased lipase † 1  0/6 (0.00%)  1/10 (10.00%) 
Lymphocytes decrease † 1  2/6 (33.33%)  4/10 (40.00%) 
Neutrophil count decrease † 1  1/6 (16.67%)  0/10 (0.00%) 
Platelet count decrease † 1  6/6 (100.00%)  5/10 (50.00%) 
White blood cells decrease † 1  2/6 (33.33%)  3/10 (30.00%) 
aPTT increase † 1  0/6 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
ALT increase † 1  3/6 (50.00%)  3/10 (30.00%) 
AST increase † 1  3/6 (50.00%)  3/10 (30.00%) 
Anorexia † 1  3/6 (50.00%)  0/10 (0.00%) 
Hypercalcemia † 1  1/6 (16.67%)  0/10 (0.00%) 
Hyperglycemia † 1  0/6 (0.00%)  3/10 (30.00%) 
Hyperkalemia † 1  1/6 (16.67%)  0/10 (0.00%) 
Hypoalbuminemia † 1  2/6 (33.33%)  4/10 (40.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/6 (16.67%)  3/10 (30.00%) 
Muscle weakness † 1  1/6 (16.67%)  0/10 (0.00%) 
Nervous system disorders     
Dizziness † 1  1/6 (16.67%)  2/10 (20.00%) 
Tingling of lips † 1  0/6 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Anxiety † 1  2/6 (33.33%)  1/10 (10.00%) 
Depression † 1  0/6 (0.00%)  1/10 (10.00%) 
Insomnia † 1  2/6 (33.33%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  1/6 (16.67%)  1/10 (10.00%) 
Dyspnea † 1  3/6 (50.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Dry skin † 1  1/6 (16.67%)  0/10 (0.00%) 
Nail ridging † 1  0/6 (0.00%)  1/10 (10.00%) 
Palmar-plantar † 1  1/6 (16.67%)  1/10 (10.00%) 
Rash maculo-papular † 1  2/6 (33.33%)  0/10 (0.00%) 
Vascular disorders     
Hypertension † 1  2/6 (33.33%)  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrea Wang-Gillam, M.D., Ph.D.
Organization: Washington University School of Medicine
Phone: 314-362-5740
EMail: awang-gillam@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02352831    
Other Study ID Numbers: 201503074
First Submitted: January 28, 2015
First Posted: February 2, 2015
Results First Submitted: October 16, 2018
Results First Posted: December 17, 2018
Last Update Posted: August 28, 2019