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A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas

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: NCT02448537
Recruitment Status : Active, not recruiting
First Posted : May 19, 2015
Results First Posted : March 5, 2018
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
PharmaMar
Information provided by (Responsible Party):
Gregory Cote, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Sarcoma
Interventions Drug: PM01183
Drug: Doxorubicin
Drug: Gemcitabine
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PM01183 and Doxorubicin PM01183 and Gemcitabine Single Agent PM01183
Hide Arm/Group Description

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Period Title: Overall Study
Started 20 10 12
Completed 19 9 11
Not Completed 1 1 1
Reason Not Completed
Withdrawal by Subject             1             1             1
Arm/Group Title PM01183 and Doxorubicin PM01183 and Gemcitabine Single Agent PM01183 Total
Hide Arm/Group Description

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Total of all reporting groups
Overall Number of Baseline Participants 20 10 12 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 10 participants 12 participants 42 participants
52.6
(31.8 to 74.2)
44.2
(29.6 to 74.5)
55.3
(30.0 to 71.7)
51.9
(29.6 to 74.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 12 participants 42 participants
Female
13
  65.0%
6
  60.0%
7
  58.3%
26
  61.9%
Male
7
  35.0%
4
  40.0%
5
  41.7%
16
  38.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 12 participants 42 participants
Hispanic or Latino
2
  10.0%
1
  10.0%
0
   0.0%
3
   7.1%
Not Hispanic or Latino
18
  90.0%
8
  80.0%
11
  91.7%
37
  88.1%
Unknown or Not Reported
0
   0.0%
1
  10.0%
1
   8.3%
2
   4.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 12 participants 42 participants
White
15
  75.0%
7
  70.0%
11
  91.7%
33
  78.6%
Black or African-American
2
  10.0%
1
  10.0%
0
   0.0%
3
   7.1%
Asian
1
   5.0%
0
   0.0%
0
   0.0%
1
   2.4%
More Than One Race
2
  10.0%
1
  10.0%
0
   0.0%
3
   7.1%
Other
0
   0.0%
1
  10.0%
1
   8.3%
2
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 10 participants 12 participants 42 participants
20 10 12 42
1.Primary Outcome
Title Disease Control Rate
Hide Description

The number of participants that achieved either Stable Disease (SD) or a Partial Response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at 24 weeks.

  • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants (one from the PM01183 and Doxorubicin arm and one from the PM01183 alone arm) were not able to be evaluated for response.
Arm/Group Title PM01183 and Doxorubicin PM01183 and Gemcitabine Single Agent PM01183
Hide Arm/Group Description:

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Overall Number of Participants Analyzed 17 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
13
  76.5%
2
  20.0%
3
  30.0%
2.Secondary Outcome
Title Overall Response Rate
Hide Description

The overall response rate is the number of participants that achieved either Stable Disease (SD), a Partial Response (PR), or a Complete Response (CR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The overall response rate is the best response recorded from the start of treatment until disease progression/recurrence.

  • 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.
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Every 6 weeks for the first 8 cycles (cycle is 21 days) and then every 9 weeks thereafter until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PM01183 and Doxorubicin PM01183 and Gemcitabine Single Agent PM01183
Hide Arm/Group Description:

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Overall Number of Participants Analyzed 20 10 12
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
7
  35.0%
1
  10.0%
0
   0.0%
Stable Disease
6
  30.0%
1
  10.0%
3
  25.0%
Unknown
1
   5.0%
0
   0.0%
1
   8.3%
3.Secondary Outcome
Title Overall Survival Rate
Hide Description Overall survival is measured as the median duration of time from the start of treatment until the time of death.
Time Frame from the start of treatment until death
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Treatment Related Serious Adverse Events
Hide Description Summary of the serious adverse events (SAE) experienced by participants that were deemed to be at least possibly related to PM01183 when administered alone or with Doxorubicin or Gemcitabine. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).
Time Frame From the start of treatment until 30 days after the end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PM01183 and Doxorubicin PM01183 and Gemcitabine Single Agent PM01183
Hide Arm/Group Description:

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Overall Number of Participants Analyzed 20 10 12
Measure Type: Number
Unit of Measure: participants
Diarrhea 1 0 1
Febrile neutropenia 1 1 0
Lymphocyte count decreased 2 1 0
Nausea 1 0 1
Neutrophil count decreased 4 4 1
Platelet count decreased 1 1 0
Port Infection 0 1 0
Vomiting 1 0 1
White blood cell decreased 3 1 0
Any Treatment Related SAE 4 5 2
Time Frame From the start of treatment until 30 days after the end of treatment.Treatment continued until the participant had disease progression, intercurrent illness that prevented further administration of treatment, an unacceptable adverse event, the participant withdrew from the study, or until the treating investigator decided it would be in the participants best interest.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stratum A Stratum B Stratum C
Hide Arm/Group Description

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

  • PM01183 predetermined dose daily via IV per cycle
  • Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Prior anthracycline exposure and without prior gemcitabine exposure

  • PM01183 predetermined dose given twice via IV per cycle
  • Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

All-Cause Mortality
Stratum A Stratum B Stratum C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/10 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Stratum A Stratum B Stratum C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      6/10 (60.00%)      4/12 (33.33%)    
Blood and lymphatic system disorders       
Anemia  1  0/20 (0.00%)  0 1/10 (10.00%)  2 0/12 (0.00%)  0
Febrile neutropenia  1  1/20 (5.00%)  1 1/10 (10.00%)  1 0/12 (0.00%)  0
Cardiac disorders       
Ventricular arrhythmia  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Diarrhea  1  1/20 (5.00%)  1 0/10 (0.00%)  0 1/12 (8.33%)  1
Ileus  1  1/20 (5.00%)  3 0/10 (0.00%)  0 0/12 (0.00%)  0
Nausea  1  1/20 (5.00%)  1 0/10 (0.00%)  0 1/12 (8.33%)  1
Small intestinal obstruction  1  1/20 (5.00%)  3 0/10 (0.00%)  0 1/12 (8.33%)  1
Vomiting  1  1/20 (5.00%)  1 0/10 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations       
Infections and infestations - Other, Port Infection  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Infections and infestations - Other, Spontaneous Bacterial Peritonitis  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Investigations       
Lymphocyte count decreased  1  2/20 (10.00%)  3 1/10 (10.00%)  1 0/12 (0.00%)  0
Neutrophil count decreased  1  4/20 (20.00%)  6 4/10 (40.00%)  5 1/12 (8.33%)  1
Platelet count decreased  1  1/20 (5.00%)  1 1/10 (10.00%)  6 0/12 (0.00%)  0
White blood cell decreased  1  3/20 (15.00%)  5 1/10 (10.00%)  1 0/12 (0.00%)  0
Nervous system disorders       
Intracranial hemorrhage  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Renal and urinary disorders       
Urinary incontinence  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Surgical and medical procedures       
Surgical and medical procedures - Other, Grade 3 Decompression and Spinal Stabilization  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (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 0%
Stratum A Stratum B Stratum C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      10/10 (100.00%)      11/12 (91.67%)    
Blood and lymphatic system disorders       
Anemia  1  2/20 (10.00%)  2 3/10 (30.00%)  9 1/12 (8.33%)  3
Cardiac disorders       
Cardiac disorders - Other, Heart Murmur  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Cardiac disorders - Other, Systolic Ejection Murmur  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Cardiac disorders - Other, tachycardia  1  1/20 (5.00%)  1 1/10 (10.00%)  1 0/12 (0.00%)  0
Cardiac disorders - Other, Unspecified  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Chest pain - cardiac  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Ventricular tachycardia  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other, Ear Rash  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Ear pain  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Vertigo  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Endocrine disorders       
Endocrine disorders - Other, Polydispia/Polyuria  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Eye disorders       
Blurred vision  1  2/20 (10.00%)  3 0/10 (0.00%)  0 0/12 (0.00%)  0
Cataract  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Conjunctivitis  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Dry eye  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Eye disorders - Other, Left Eyelid Stye  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Eye disorders - Other, Vision Straining  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Watering eyes  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  3/20 (15.00%)  4 1/10 (10.00%)  1 0/12 (0.00%)  0
Constipation  1  10/20 (50.00%)  19 5/10 (50.00%)  6 2/12 (16.67%)  2
Diarrhea  1  6/20 (30.00%)  8 3/10 (30.00%)  3 1/12 (8.33%)  1
Duodenal hemorrhage  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Dyspepsia  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Esophageal necrosis  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Flatulence  1  2/20 (10.00%)  2 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastroesophageal reflux disease  1  4/20 (20.00%)  4 1/10 (10.00%)  1 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Abdominal Cramps  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Abdominal Pressure  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Early Satiety  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Gas Pain  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Intermittent Dysgeusia  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Gastrointestinal disorders - Other, Partial Small Bowel Obstruction  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Hemorrhoids  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Mucositis oral  1  5/20 (25.00%)  8 0/10 (0.00%)  0 0/12 (0.00%)  0
Nausea  1  16/20 (80.00%)  25 5/10 (50.00%)  7 5/12 (41.67%)  6
Vomiting  1  9/20 (45.00%)  10 1/10 (10.00%)  1 3/12 (25.00%)  3
General disorders       
Edema limbs  1  3/20 (15.00%)  3 0/10 (0.00%)  0 1/12 (8.33%)  1
Fatigue  1  18/20 (90.00%)  28 8/10 (80.00%)  11 5/12 (41.67%)  5
Fever  1  1/20 (5.00%)  1 1/10 (10.00%)  1 1/12 (8.33%)  1
General disorders and administration site conditions - Other, Abdominal Tenderness  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Chest Aching  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Duodenitis  1  0/20 (0.00%)  0 1/10 (10.00%)  2 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Itchy Eyes  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
General disorders and administration site conditions - Other, Sensitivity to Smells  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Shingles  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Shoulder Pain  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Transfusion Reaction  1  0/20 (0.00%)  0 1/10 (10.00%)  3 0/12 (0.00%)  0
General disorders and administration site conditions - Other, Vascular Rash  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Non-cardiac chest pain  1  1/20 (5.00%)  1 1/10 (10.00%)  1 0/12 (0.00%)  0
Pain  1  3/20 (15.00%)  4 0/10 (0.00%)  0 1/12 (8.33%)  1
Immune system disorders       
Immune system disorders - Other, Cold Sore  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Infections and infestations - Other, Left Great Toe, Mild, Localized  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Infections and infestations - Other, Thrush  1  3/20 (15.00%)  3 0/10 (0.00%)  0 2/12 (16.67%)  2
Infections and infestations - Other, unspecified  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Infections and infestations       
Upper respiratory infection  1  1/20 (5.00%)  1 2/10 (20.00%)  2 0/12 (0.00%)  0
Urinary tract infection  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications       
Bruising  1  0/20 (0.00%)  0 2/10 (20.00%)  2 0/12 (0.00%)  0
Radiation recall reaction (dermatologic)  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/20 (0.00%)  0 1/10 (10.00%)  1 1/12 (8.33%)  1
Alkaline phosphatase increased  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Aspartate aminotransferase increased  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Carbon monoxide diffusing capacity decreased  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  2
Investigations - Other, Leg Swelling  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Lymphocyte count decreased  1  0/20 (0.00%)  0 1/10 (10.00%)  1 1/12 (8.33%)  4
Neutrophil count decreased  1  3/20 (15.00%)  3 3/10 (30.00%)  4 2/12 (16.67%)  3
Platelet count decreased  1  0/20 (0.00%)  0 2/10 (20.00%)  6 0/12 (0.00%)  0
Weight loss  1  6/20 (30.00%)  6 2/10 (20.00%)  2 1/12 (8.33%)  1
White blood cell decreased  1  1/20 (5.00%)  1 2/10 (20.00%)  2 1/12 (8.33%)  3
Metabolism and nutrition disorders       
Anorexia  1  9/20 (45.00%)  12 3/10 (30.00%)  3 2/12 (16.67%)  2
Dehydration  1  3/20 (15.00%)  3 1/10 (10.00%)  1 0/12 (0.00%)  0
Hyperglycemia  1  0/20 (0.00%)  0 1/10 (10.00%)  1 2/12 (16.67%)  3
Hypocalcemia  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  6
Hypophosphatemia  1  0/20 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/20 (10.00%)  2 0/10 (0.00%)  0 0/12 (0.00%)  0
Back pain  1  5/20 (25.00%)  6 0/10 (0.00%)  0 0/12 (0.00%)  0
Bone pain  1  2/20 (10.00%)  2 0/10 (0.00%)  0 0/12 (0.00%)  0
Generalized muscle weakness  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Muscle weakness lower limb  1  0/20 (0.00%)  0 1/10 (10.00%)  2 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Intermittent Bodyaching  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Toe Cramping  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Myalgia  1  3/20 (15.00%)  3 0/10 (0.00%)  0 2/12 (16.67%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Nervous system disorders       
Dizziness  1  3/20 (15.00%)  3 0/10 (0.00%)  0 0/12 (0.00%)  0
Dysgeusia  1  3/20 (15.00%)  3 0/10 (0.00%)  0 1/12 (8.33%)  1
Headache  1  5/20 (25.00%)  5 2/10 (20.00%)  2 2/12 (16.67%)  2
Memory impairment  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders - Other, Light-Headedness  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Paresthesia  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Psychiatric disorders       
Anxiety  1  6/20 (30.00%)  6 3/10 (30.00%)  3 0/12 (0.00%)  0
Depression  1  2/20 (10.00%)  2 1/10 (10.00%)  1 0/12 (0.00%)  0
Insomnia  1  7/20 (35.00%)  7 3/10 (30.00%)  3 1/12 (8.33%)  1
Renal and urinary disorders       
Renal and urinary disorders - Other, Cloudy Urine  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Renal and urinary disorders - Other, Intermittent Urinary Pressure  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Renal and urinary disorders - Other, Urinary Hesitancy  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Urinary frequency  1  1/20 (5.00%)  2 0/10 (0.00%)  0 0/12 (0.00%)  0
Urinary incontinence  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Urinary urgency  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Reproductive system and breast disorders       
Dyspareunia  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  4/20 (20.00%)  5 3/10 (30.00%)  3 3/12 (25.00%)  3
Dyspnea  1  3/20 (15.00%)  3 4/10 (40.00%)  4 1/12 (8.33%)  1
Nasal congestion  1  2/20 (10.00%)  2 0/10 (0.00%)  0 1/12 (8.33%)  1
Postnasal drip  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Productive cough  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Sore throat  1  2/20 (10.00%)  3 2/10 (20.00%)  2 0/12 (0.00%)  0
Voice alteration  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  8/20 (40.00%)  8 2/10 (20.00%)  2 0/12 (0.00%)  0
Erythema multiforme  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Rash maculo-papular  1  1/20 (5.00%)  1 2/10 (20.00%)  2 1/12 (8.33%)  1
Scalp pain  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Skin/subcutaneous tissue disorders; Other, Contact Dermatitis  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Skin/subcutaneous tissue disorders; Other, Nail Change - Brittle  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Skin/subcutaneous tissue disorders; Other, Rash  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Skin/subcutaneous tissue disorders; Other, Vascular Rash  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
Vascular disorders       
Hematoma  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Hot flashes  1  4/20 (20.00%)  4 0/10 (0.00%)  0 0/12 (0.00%)  0
Hypertension  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Hypotension  1  1/20 (5.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0
Thromboembolic event  1  0/20 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Gregory Cote, M.D., Ph.D
Organization: Massachusetts General Hospital
Phone: 617-724-4000
EMail: gcote@partners.org
Layout table for additonal information
Responsible Party: Gregory Cote, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02448537    
Other Study ID Numbers: 15-083
First Submitted: May 15, 2015
First Posted: May 19, 2015
Results First Submitted: February 5, 2018
Results First Posted: March 5, 2018
Last Update Posted: November 15, 2019