Trial Outcomes & Findings for A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck (NCT NCT01285635)
NCT ID: NCT01285635
Last Updated: 2016-03-31
Results Overview
The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
12 months
Results posted on
2016-03-31
Participant Flow
Patients will receive arm specific therapy for the first two cycles, then all patients will be switched into the metronomic AT-101 arm for up to 10 cycles.
Participant milestones
| Measure |
Docetaxel Then Metronomic AT-101
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
13
|
11
|
11
|
|
First Intervention (2 Weeks)
COMPLETED
|
13
|
11
|
11
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (10, 3 Week Cycles)
STARTED
|
13
|
11
|
11
|
|
Second Intervention (10, 3 Week Cycles)
COMPLETED
|
13
|
11
|
11
|
|
Second Intervention (10, 3 Week Cycles)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck
Baseline characteristics by cohort
| Measure |
Docetaxel Then Metronomic AT-101
n=13 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 Participants
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
|
Metronomic AT-101 Arm
n=11 Participants
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
59 years
n=5 Participants
|
56 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Docetaxel Then Metronomic AT-101
n=13 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 Participants
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 Participants
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Number of Patients With a Complete Response (CR) and Partial Response (PR)
Number of Patients with a CR
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With a Complete Response (CR) and Partial Response (PR)
Number of Patients with a PR
|
1 Patients
|
1 Patients
|
2 Patients
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients on study
Outcome measures
| Measure |
Docetaxel Then Metronomic AT-101
n=35 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Median Duration of Response For All Groups Combined
|
1.9 months
Interval 0.2 to 16.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsMeasure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic SCCHN
Outcome measures
| Measure |
Docetaxel Then Metronomic AT-101
n=13 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 Participants
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 Participants
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Fatigue
|
2 participants
|
1 participants
|
0 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Anorexia
|
1 participants
|
2 participants
|
1 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Nausea
|
1 participants
|
5 participants
|
0 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Bowel Obstruction
|
1 participants
|
0 participants
|
1 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Hematologic
|
14 participants
|
8 participants
|
4 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Infectious
|
4 participants
|
0 participants
|
1 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Respiratory
|
1 participants
|
0 participants
|
3 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Edema
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Grade 3 and 4 Toxicities by Arm
Other
|
1 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 YearsOutcome measures
| Measure |
Docetaxel Then Metronomic AT-101
n=13 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 Participants
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 Participants
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Median Overall Survival in Months
|
8.3 months
Interval 5.5 to 9.9
|
4.9 months
Interval 2.1 to 24.0
|
4.9 months
Interval 2.7 to 13.7
|
SECONDARY outcome
Timeframe: 3 YearsProgression is defined, by RECIST (Response Evaluation Criteria in Solid Tumors), as at least a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Docetaxel Then Metronomic AT-101
n=13 Participants
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 Participants
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 Participants
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Median Progression Free Survival in Months
|
4.5 months
Interval 2.6 to 9.9
|
2.8 months
Interval 1.2 to 5.9
|
4.2 months
Interval 1.2 to 5.6
|
Adverse Events
Docetaxel Then Metronomic AT-101
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Pulse AT-101 Then Metronomic AT-101
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Metronomic AT-101 Arm
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel Then Metronomic AT-101
n=13 participants at risk
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 participants at risk
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 participants at risk
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.7%
1/13
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Fatigue
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Vascular disorders
Hematoma
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Jejunal obstruction
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
15.4%
2/13
|
27.3%
3/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Infections and infestations
Periorbital infection
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
7.7%
1/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Nervous system disorders
Syncope
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Pain
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
|
18.2%
2/11
|
0.00%
0/11
|
|
General disorders
Death NOS
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Cardiac disorders
Hypotension
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Sepsis
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
Other adverse events
| Measure |
Docetaxel Then Metronomic AT-101
n=13 participants at risk
Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Pulse AT-101 Then Metronomic AT-101
n=11 participants at risk
AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
Metronomic AT-101 Arm
n=11 participants at risk
AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Eye disorders
Eye pain
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Flu like symptoms
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Endocrine disorders
Hot flashes
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Endocrine disorders
Hyperhidrosis
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
General disorders
Lethargy
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Skin infection
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Surgical and medical procedures - Other
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/13
|
27.3%
3/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13
|
0.00%
0/11
|
18.2%
2/11
|
|
Psychiatric disorders
Cognitive disturbance
|
0.00%
0/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13
|
0.00%
0/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Sinus pain
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Psychiatric disorders
Agitation
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13
|
27.3%
3/11
|
9.1%
1/11
|
|
Investigations
Alkaline phosphatase increased
|
23.1%
3/13
|
18.2%
2/11
|
27.3%
3/11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
3/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Anemia
|
61.5%
8/13
|
81.8%
9/11
|
63.6%
7/11
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
4/13
|
54.5%
6/11
|
27.3%
3/11
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
4/13
|
27.3%
3/11
|
18.2%
2/11
|
|
Cardiac disorders
Atrial flutter
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13
|
9.1%
1/11
|
27.3%
3/11
|
|
Eye disorders
Blurred vision
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
1/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Investigations
Cholesterol high
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13
|
36.4%
4/11
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13
|
45.5%
5/11
|
9.1%
1/11
|
|
Investigations
Creatinine increased
|
23.1%
3/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13
|
0.00%
0/11
|
18.2%
2/11
|
|
Psychiatric disorders
Delirium
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Psychiatric disorders
Depression
|
7.7%
1/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13
|
27.3%
3/11
|
36.4%
4/11
|
|
Ear and labyrinth disorders
Dizziness
|
23.1%
3/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
1/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dysphagia
|
23.1%
3/13
|
27.3%
3/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13
|
45.5%
5/11
|
18.2%
2/11
|
|
General disorders
Edema limbs
|
15.4%
2/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
2/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Eye disorders
Eye disorders - Other
|
15.4%
2/13
|
0.00%
0/11
|
9.1%
1/11
|
|
General disorders
Fatigue
|
61.5%
8/13
|
63.6%
7/11
|
45.5%
5/11
|
|
General disorders
Fever
|
7.7%
1/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.4%
2/13
|
27.3%
3/11
|
9.1%
1/11
|
|
General disorders
Genital edema
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
15.4%
2/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Vascular disorders
Hematoma
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
15.4%
2/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.5%
5/13
|
45.5%
5/11
|
45.5%
5/11
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13
|
18.2%
2/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
2/13
|
27.3%
3/11
|
27.3%
3/11
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.1%
3/13
|
36.4%
4/11
|
27.3%
3/11
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13
|
9.1%
1/11
|
18.2%
2/11
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Investigations
INR increased
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Infections and infestations
Infections and infestations - Other
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Laryngeal inflammation
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
General disorders
Localized edema
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Vascular disorders
Lymph node pain
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Vascular disorders
Lymphedema
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
38.5%
5/13
|
45.5%
5/11
|
45.5%
5/11
|
|
Gastrointestinal disorders
Mucositis oral
|
15.4%
2/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.1%
3/13
|
18.2%
2/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13
|
54.5%
6/11
|
27.3%
3/11
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Nervous system disorders - Other
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
23.1%
3/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Ear and labyrinth disorders
Otitis externa
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
General disorders
Pain
|
23.1%
3/13
|
18.2%
2/11
|
18.2%
2/11
|
|
General disorders
Pain in extremity
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
15.4%
2/13
|
18.2%
2/11
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
15.4%
2/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
2/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Eye disorders
Scleral disorder
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.7%
1/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Sore throat
|
7.7%
1/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Nervous system disorders
Stroke
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Transient ischemic attacks
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
General disorders
Tremor
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Vascular disorders
Vascular disorders - Other
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13
|
36.4%
4/11
|
0.00%
0/11
|
|
Eye disorders
Watering eyes
|
7.7%
1/13
|
0.00%
0/11
|
0.00%
0/11
|
|
General disorders
Weight loss
|
23.1%
3/13
|
27.3%
3/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13
|
9.1%
1/11
|
18.2%
2/11
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
23.1%
3/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13
|
27.3%
3/11
|
0.00%
0/11
|
|
General disorders
Chills
|
0.00%
0/13
|
18.2%
2/11
|
0.00%
0/11
|
|
General disorders
Edema face
|
0.00%
0/13
|
9.1%
1/11
|
9.1%
1/11
|
|
General disorders
Facial pain
|
0.00%
0/13
|
9.1%
1/11
|
18.2%
2/11
|
|
General disorders
Gingival pain
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/13
|
27.3%
3/11
|
0.00%
0/11
|
|
Cardiac disorders
Hypertension
|
0.00%
0/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/13
|
18.2%
2/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13
|
9.1%
1/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13
|
18.2%
2/11
|
0.00%
0/11
|
|
General disorders
Malaise
|
0.00%
0/13
|
9.1%
1/11
|
0.00%
0/11
|
Additional Information
Dr. Francis Worden, M.D.
University of Michigan Cancer Center
Phone: 734-936-0453
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place