Trial Outcomes & Findings for Study of Pazopanib and Ixabepilone in Patients With Solid Tumors (NCT NCT01012362)
NCT ID: NCT01012362
Last Updated: 2017-12-28
Results Overview
The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for \> 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC \> 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Week 3 of each dose level
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
Arm 1: Dose Level 1
Pazopanib 400mg - Ixabepilone 32mg/m2
|
Arm 1: Dose Level 2
Pazopanib 400mg - Ixabepilone 40mg/m2
|
Arm 1: Dose Level 3
Pazopanib 600mg - Ixabepilone 32 mg/m2
|
Arm 1: Dose Level 4
Pazopanib 800mg - Ixabepilone 32 mg//m2
|
Arm 2
Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
3
|
4
|
9
|
|
Overall Study
COMPLETED
|
9
|
6
|
3
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm 1: Dose Level 1
n=9 Participants
Pazopanib 400mg - Ixabepilone 32mg/m2
|
Arm 1: Dose Level 2
n=6 Participants
Pazopanib 400mg - Ixabepilone 40mg/m2
|
Arm 1: Dose Level 3
n=3 Participants
Pazopanib 600mg - Ixabepilone 32 mg/m2
|
Arm 1: Dose Level 4
n=4 Participants
Pazopanib 800mg - Ixabepilone 32 mg//m2
|
Arm 2
n=9 Participants
Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 3 of each dose levelThe optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for \> 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC \> 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
Outcome measures
| Measure |
All Arm 1 Participants
n=22 Participants
All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
|
Arm 1: Dose Level 2
400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
|
Arm 1: Dose Level 3
600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 1: Dose Level 4
800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 2: Dose Level 3
6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
|---|---|---|---|---|---|
|
The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
|
3 Dose Level
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 3 of each dosePopulation: 6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.
A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for \>7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding \>/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by \>2 weeks due to incomplete hematologic recovery (absolute neutrophil count \> 1.5 X 10\^9/L or platelets \>100 X 10\^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).
Outcome measures
| Measure |
All Arm 1 Participants
n=9 Participants
All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
|
Arm 1: Dose Level 2
n=6 Participants
400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
|
Arm 1: Dose Level 3
n=3 Participants
600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 1: Dose Level 4
n=4 Participants
800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 2: Dose Level 3
n=9 Participants
6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days post treatmentPopulation: Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.
Outcome measures
| Measure |
All Arm 1 Participants
n=9 Participants
All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
|
Arm 1: Dose Level 2
n=6 Participants
400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
|
Arm 1: Dose Level 3
n=12 Participants
600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 1: Dose Level 4
n=4 Participants
800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
Arm 2: Dose Level 3
6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events
|
9 Participants
|
6 Participants
|
12 Participants
|
4 Participants
|
—
|
Adverse Events
Dose Level 1
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=9 participants at risk
Pazopanib 400mg - Ixabepilone 32mg/m2
|
Dose Level 2
n=6 participants at risk
Pazopanib 400mg - Ixabepilone 40mg/m2
|
Dose Level 3
n=12 participants at risk
Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
|
Dose Level 4
n=4 participants at risk
Pazopanib 800mg - Ixabepilone 32 mg//m2
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Infection
|
0.00%
0/9
|
16.7%
1/6
|
25.0%
3/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Fatigue
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Decreased Platelets
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
General disorders
Death due to Disease Progression
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Nervous system disorders
Seizure
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Chest Wall Pain
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction of Airway
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
Other adverse events
| Measure |
Dose Level 1
n=9 participants at risk
Pazopanib 400mg - Ixabepilone 32mg/m2
|
Dose Level 2
n=6 participants at risk
Pazopanib 400mg - Ixabepilone 40mg/m2
|
Dose Level 3
n=12 participants at risk
Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
|
Dose Level 4
n=4 participants at risk
Pazopanib 800mg - Ixabepilone 32 mg//m2
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Bloating
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
6/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9
|
50.0%
3/6
|
33.3%
4/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9
|
50.0%
3/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Ankle Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
3/9
|
50.0%
3/6
|
41.7%
5/12
|
50.0%
2/4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Cramping
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Bleeding Gums
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Bleeding Neck Wound
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Eye disorders
Blurred Vision
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Nervous system disorders
Burning Sensation, Hand
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Chest/Rib Pain
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
General disorders
Chills
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9
|
33.3%
2/6
|
8.3%
1/12
|
50.0%
2/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9
|
33.3%
2/6
|
8.3%
1/12
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Decrease Platelets
|
11.1%
1/9
|
33.3%
2/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Vascular disorders
Deep Vein Thrombosis
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Delayed Wound Healing
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9
|
33.3%
2/6
|
50.0%
6/12
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9
|
33.3%
2/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Ear/Head
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Vascular disorders
Edema, Glans Penis
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Vascular disorders
Edema, Limbs
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Eye disorders
Edema, Periorbital
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Erythema, Arm
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Eye disorders
Eye Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Eye disorders
Eye Twitch
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Fatigue
|
44.4%
4/9
|
66.7%
4/6
|
83.3%
10/12
|
75.0%
3/4
|
|
General disorders
Fever
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Fever with Neutropenia
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
General disorders
Flu-Like Syndrome
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Folliculitis, Leg
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Fracture, Arm
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Infections and infestations
Fungal Infection, Feet
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Genreralized Body Aches
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Hand Pain
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
11.1%
1/9
|
16.7%
1/6
|
33.3%
4/12
|
25.0%
1/4
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hemoglobin, NOS
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
0.00%
0/9
|
0.00%
0/6
|
25.0%
3/12
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation, Eyelashes and Eyebrows
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation, Hair
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Vascular disorders
Hypotension
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Investigations
Increased Liver Enzyme, ALT
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Increased Liver Enzyme, AST
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
General disorders
Increased Sweating
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Increased Trachea Secretions
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Infection, Lung
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Infection, NOS
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Infection, Port Incision
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Infection, Urinary
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Jaw/Neck Wound Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
General disorders
Joint Pain
|
11.1%
1/9
|
16.7%
1/6
|
33.3%
4/12
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
General disorders
Leg Pain
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Leukocytes, NOS
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Lymphedema
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Mucositis
|
11.1%
1/9
|
0.00%
0/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
25.0%
1/4
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9
|
50.0%
3/6
|
75.0%
9/12
|
50.0%
2/4
|
|
General disorders
Neck Pain
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Nervous system disorders
Neuropathy, NOS
|
11.1%
1/9
|
33.3%
2/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
6/9
|
100.0%
6/6
|
33.3%
4/12
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Neutrophils, NOS
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Investigations
Partial Thromboplastin Time, NOS
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/9
|
0.00%
0/6
|
33.3%
4/12
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Platelets, NOS
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9
|
0.00%
0/6
|
16.7%
2/12
|
25.0%
1/4
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Reflux
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinnorhea
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Scrotal Cysts
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Nervous system disorders
Seizure
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown near Gastrostomy Tube
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Gastrointestinal disorders
Taste Alteration
|
11.1%
1/9
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Throat Pain
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/4
|
|
Nervous system disorders
Tremor
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Renal and urinary disorders
Urinary Leakage
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Infections and infestations
Viral Infection, NOS
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9
|
33.3%
2/6
|
50.0%
6/12
|
50.0%
2/4
|
|
Musculoskeletal and connective tissue disorders
Weakness, NOS
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Weepy Scalp
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
|
Investigations
Weight Loss
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/4
|
Additional Information
Dr. Arkadiusz Dudek
Masonic Cancer Center, University of Minnesota
Phone: 651-254-3321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place