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Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02888665
Recruitment Status : Completed
First Posted : September 5, 2016
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Seth Pollack, Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Interventions Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1, Part 1 Phase 1, Part 2 Phase 2
Hide Arm/Group Description Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose pembrolizumab.
Period Title: Overall Study
Started 3 3 31
Completed 3 3 31
Not Completed 0 0 0
Arm/Group Title Phase 1, Part 1 Phase 1, Part 2 Phase 2 Total
Hide Arm/Group Description Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin + 200 mg flat dose pembrolizumab. Total of all reporting groups
Overall Number of Baseline Participants 3 3 31 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 31 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
2
  66.7%
23
  74.2%
27
  73.0%
>=65 years
1
  33.3%
1
  33.3%
8
  25.8%
10
  27.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 31 participants 37 participants
Female
0
   0.0%
1
  33.3%
14
  45.2%
15
  40.5%
Male
3
 100.0%
2
  66.7%
17
  54.8%
22
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 31 participants 37 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
4
  12.9%
5
  13.5%
Not Hispanic or Latino
3
 100.0%
2
  66.7%
26
  83.9%
31
  83.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.2%
1
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 31 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   6.5%
2
   5.4%
Asian
0
   0.0%
0
   0.0%
2
   6.5%
2
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   3.2%
1
   2.7%
White
3
 100.0%
2
  66.7%
22
  71.0%
27
  73.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  33.3%
4
  12.9%
5
  13.5%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Doxorubicin Hydrochloride Plus Pembrolizumab According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) Version 4.0 (Phase I)
Hide Description Defined as a dose limiting toxicity (DLT) in less than 2 of 6 subjects. Only Phase 1 subjects will be evaluated for MTD.
Time Frame Up to 42 days (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Only Phase 1 subjects were evaluated for a Maximum Tolerated Dose (MTD) based off of Dose-Limiting Toxicities experienced per subject as defined in the protocol.
Arm/Group Title Phase 1 Cohort 1 Phase 1 Cohort 2
Hide Arm/Group Description:
Subjects received 45 mg/m2 of doxorubicin plus 200 mg flat dose of pembrolizumab.
Subjects received 75 mg/m2 of doxorubicin plus 200 mg flat dose of pembrolizumab.
Overall Number of Participants Analyzed 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Objective Response Rate (ORR) (Phase II)
Hide Description Evaluated per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT. Complete Response (CR) is a complete elimination of the tumor; Partial Response (PR) is 30% reduction. If a subject experienced a PR, this was required to be confirmed with a second scan at the next appropriate cycle.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only Phase 2 subjects were evaluated for this outcome as Phase 1 subjects were only included in the protocol for safety evaluation.
Arm/Group Title Phase 2: Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percent of participants
13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Comments The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis see above. target ORR was not met.
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is the mean time to progression for all subjects who responded.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 appropriate subjects had partial responses for evaluation.
Arm/Group Title Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Days
247  (180)
4.Secondary Outcome
Title Median Progression-free Survival (PFS)
Hide Description The Kaplan-Meier method will be used to estimate median PFS.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This combined the phase I and phase II populations as we had intended for this analysis.
Arm/Group Title Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: months
8.1
(7.6 to 10.8)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The Kaplan-Meier method will be used to estimate median OS.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This combined the phase I and phase II populations as we had intended for this analysis.
Arm/Group Title Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: months
27.6 [1] 
(18.7 to NA)
[1]
At the time of the final analysis, the upper limit had not yet been reached.
6.Secondary Outcome
Title Time to Response
Hide Description Average time to response
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 appropriate subjects had partial responses for evaluation.
Arm/Group Title Treatment (Pembrolizumab, Doxorubicin Hydrochloride)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1 and doxorubicin hydrochloride IV over 1-3 hours on day 1 of courses 2-7 only. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Pembrolizumab: Given IV

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Days
152.2  (65)
Time Frame Adverse event data was collected beginning from date of consent to 30 days post discontinuation of study treatment. (Up to 2 years of therapy with 1 cycle equaling 21 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 Cohort 1 Phase 1 Cohort 2 Phase 2
Hide Arm/Group Description Subjects received 45 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin plus 200 mg flat dose of pembrolizumab. Subjects received 75 mg/m2 doxorubicin plus 200 mg flat dose pembrolizumab.
All-Cause Mortality
Phase 1 Cohort 1 Phase 1 Cohort 2 Phase 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)      0/3 (0.00%)      15/31 (48.39%)    
Hide Serious Adverse Events
Phase 1 Cohort 1 Phase 1 Cohort 2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      2/3 (66.67%)      13/31 (41.94%)    
Blood and lymphatic system disorders       
Febrile Neutropenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Leukocytosis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Tumor thrombus  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Cardiac disorders       
Ejection fraction decreased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Pulmonary infarct  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Heart failure  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Endocrine disorders       
Hypothyroidism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Adrenal insufficiency  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/31 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  3
Diarrhea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Constipation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Partial Bowel Obstruction  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/31 (0.00%)  0
Mid-esophageal erythema  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Denuded mucosa  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Malignant bowel obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Small bowel obstruction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Odynophagia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Ascites  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Mucositis oral  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
General disorders       
Atypical Chest Pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Postprandial Chest Pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Failure to thrive  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Non-cardiac chest pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Fever  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Infections and infestations       
Oropharyngeal thrush  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Thrush  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Urinary tract infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Pelvic infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Kidney Infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Lung infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Sepsis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Investigations       
Elevated troponin  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Pancytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Metabolism and nutrition disorders       
Anorexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Dehydration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Hyponatremia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Hyperuricemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Pelvic soft tissue necrosis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Nervous system disorders       
Lightheadedness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Convulsions  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Vasovalgal reaction  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Hemoptysis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  1
Right lower lobe infiltrate  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Pleural effusion  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Pneumothorax  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/31 (3.23%)  4
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%
Phase 1 Cohort 1 Phase 1 Cohort 2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      31/31 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 6/31 (19.35%)  8
Leukocytosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  4
Hemoptysis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Cardiac disorders       
Sinus tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  3
Incomplete Right Bundle Branch Lock  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Sinus bradycardia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Glaucoma  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Endocrine disorders       
Hypothyroidism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 8/31 (25.81%)  11
Hyperthyroidism  1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/31 (9.68%)  3
Eye disorders       
Dry Eye  1  1/3 (33.33%)  1 3/3 (100.00%)  3 5/31 (16.13%)  5
Blurred Vision  1  1/3 (33.33%)  1 0/3 (0.00%)  0 4/31 (12.90%)  4
Conjunctivitis  1  0/3 (0.00%)  0 1/3 (33.33%)  2 2/31 (6.45%)  2
Eye Pain  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/31 (0.00%)  0
Bilateral anterior uveitis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  3/3 (100.00%)  3 3/3 (100.00%)  3 27/31 (87.10%)  37
Constipation  1  1/3 (33.33%)  1 3/3 (100.00%)  3 12/31 (38.71%)  16
Dry Mouth  1  1/3 (33.33%)  1 0/3 (0.00%)  0 14/31 (45.16%)  14
Vomiting  1  1/3 (33.33%)  1 3/3 (100.00%)  3 9/31 (29.03%)  12
Mucositis oral  1  0/3 (0.00%)  0 2/3 (66.67%)  3 12/31 (38.71%)  16
Diarrhea  1  0/3 (0.00%)  0 2/3 (66.67%)  2 7/31 (22.58%)  13
Abdominal Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 6/31 (19.35%)  9
Gastroesophageal reflux disease  1  1/3 (33.33%)  2 0/3 (0.00%)  0 2/31 (6.45%)  2
Sore throat  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  3
Stomach pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Esophagitis  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/31 (3.23%)  1
Hemorrhoids  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Dental Caries  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Rectal Discharge  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Ascites  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  8
General disorders       
Fatigue  1  1/3 (33.33%)  1 3/3 (100.00%)  3 21/31 (67.74%)  26
Fever  1  1/3 (33.33%)  1 2/3 (66.67%)  2 13/31 (41.94%)  15
Pain  1  0/3 (0.00%)  0 1/3 (33.33%)  3 7/31 (22.58%)  7
Edema Limbs  1  1/3 (33.33%)  1 1/3 (33.33%)  1 6/31 (19.35%)  6
Chills  1  0/3 (0.00%)  0 1/3 (33.33%)  1 4/31 (12.90%)  4
Flu-like symptoms  1  1/3 (33.33%)  1 0/3 (0.00%)  0 3/31 (9.68%)  4
Non-cardiac chest pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  4
Infusion Related Reaction  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Pain at Port Site  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Palatal inflammation  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Infections and infestations       
Upper Respiratory Infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 8/31 (25.81%)  11
Urinary tract infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/31 (9.68%)  6
Otitis externa  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/31 (3.23%)  1
Tinea Pedis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Paronychia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications       
Bruising  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  3
Investigations       
Neutrophil Count Decreased  1  0/3 (0.00%)  0 2/3 (66.67%)  3 7/31 (22.58%)  13
Weight Loss  1  0/3 (0.00%)  0 1/3 (33.33%)  1 7/31 (22.58%)  18
Creatinine increased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 3/31 (9.68%)  4
White blood cell decreased  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/31 (6.45%)  2
Alanine aminotransferase increase  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  4
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Lymphocyte count decreased  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/31 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  2/3 (66.67%)  3 2/3 (66.67%)  3 14/31 (45.16%)  19
Hypomagnesemia  1  0/3 (0.00%)  0 2/3 (66.67%)  2 7/31 (22.58%)  9
Hypokalemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 8/31 (25.81%)  8
Hypoalbuminemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/31 (16.13%)  6
Hypocalcemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/31 (12.90%)  5
Hypophosphatemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  3
Hyperuricemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  4
Dehydration  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Bone Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 8/31 (25.81%)  9
Back Pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 7/31 (22.58%)  7
Pain in Extremity  1  1/3 (33.33%)  1 0/3 (0.00%)  0 8/31 (25.81%)  11
Generalized muscle weakness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/31 (16.13%)  5
Arthralgia  1  0/3 (0.00%)  0 1/3 (33.33%)  2 2/31 (6.45%)  2
Right Hip Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Joint Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Left Shoulder Pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Rib Pain  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Shoulder Sprain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor Pain  1  1/3 (33.33%)  2 0/3 (0.00%)  0 5/31 (16.13%)  7
Squamous Cell Carcinoma In Situ  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Nervous system disorders       
Dysgeusia  1  1/3 (33.33%)  1 2/3 (66.67%)  3 9/31 (29.03%)  9
Headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 12/31 (38.71%)  16
Dizziness  1  1/3 (33.33%)  1 1/3 (33.33%)  1 5/31 (16.13%)  7
Lightheadedness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  3
Paresthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Somnolence  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Neuropathy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Dysphasia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Restless Legs  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/31 (3.23%)  1
Delayed word recall  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Right Upper Extremity Numbness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Left Upper Extremity Numbness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Psychiatric disorders       
Insomnia  1  0/3 (0.00%)  0 2/3 (66.67%)  2 7/31 (22.58%)  8
Anxiety  1  0/3 (0.00%)  0 1/3 (33.33%)  1 7/31 (22.58%)  7
Depression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/31 (16.13%)  5
Renal and urinary disorders       
Hematuria  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/31 (3.23%)  1
Urinary frequency  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Reproductive system and breast disorders       
Erectile dysfunction  1  1/3 (33.33%)  1 1/3 (33.33%)  1 2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/3 (66.67%)  2 1/3 (33.33%)  1 11/31 (35.48%)  12
Dyspnea  1  0/3 (0.00%)  0 1/3 (33.33%)  1 9/31 (29.03%)  11
Pleural Effusion  1  1/3 (33.33%)  1 1/3 (33.33%)  2 4/31 (12.90%)  4
Postnasal drip  1  1/3 (33.33%)  1 1/3 (33.33%)  1 2/31 (6.45%)  2
Rhinorrhea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  3
Hiccups  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  7
Hypoxia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Nasal congestion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Epistaxis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Productive Cough  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  1/3 (33.33%)  1 2/3 (66.67%)  2 11/31 (35.48%)  11
Pruritis  1  1/3 (33.33%)  1 1/3 (33.33%)  1 8/31 (25.81%)  9
Rash Maculo-papular  1  1/3 (33.33%)  1 2/3 (66.67%)  2 3/31 (9.68%)  4
Rash  1  1/3 (33.33%)  1 0/3 (0.00%)  0 5/31 (16.13%)  7
Dry Skin  1  2/3 (66.67%)  2 0/3 (0.00%)  0 3/31 (9.68%)  3
Nail discoloration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/31 (12.90%)  4
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/31 (9.68%)  4
Skin Ulceration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Bump on Elbow  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Eczema  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Actinic Keratosis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Seborrheic keratosis  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Small Bump on Right Shoulder  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Skin Sensitivity  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/31 (0.00%)  0
Sebaceous cyst  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
Vascular disorders       
Hypertension  1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/31 (6.45%)  2
Hypotension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  4
Thromboembolic event  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/31 (3.23%)  1
Hot flashes  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/31 (6.45%)  2
Hematoma  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/31 (0.00%)  0
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 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: Seth Pollack, MD, Director of Sarcoma Program
Organization: Northwestern University
Phone: 312-503-5320
EMail: seth.pollack@northwestern.edu
Layout table for additonal information
Responsible Party: Seth Pollack, Northwestern University
ClinicalTrials.gov Identifier: NCT02888665    
Other Study ID Numbers: 9624
NCI-2016-01286 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9624 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG9216017 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Submitted: August 30, 2016
First Posted: September 5, 2016
Results First Submitted: March 12, 2021
Results First Posted: May 26, 2021
Last Update Posted: May 26, 2021