Trial Outcomes & Findings for S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery (NCT NCT00617708)
NCT ID: NCT00617708
Last Updated: 2022-02-08
Results Overview
Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
134 participants
Primary outcome timeframe
28 days
Results posted on
2022-02-08
Participant Flow
Participant milestones
| Measure |
Ph I: Erlotinib + Gemcitabine + IMC-A12
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine + IMC-A12
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
60
|
64
|
|
Overall Study
Eligible and Began Protocol Therapy
|
9
|
57
|
59
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
60
|
64
|
Reasons for withdrawal
| Measure |
Ph I: Erlotinib + Gemcitabine + IMC-A12
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine + IMC-A12
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
7
|
|
Overall Study
Death
|
0
|
6
|
5
|
|
Overall Study
Progression/Relapse
|
7
|
40
|
36
|
|
Overall Study
Not protocol specified
|
1
|
4
|
2
|
|
Overall Study
Not eligible
|
1
|
3
|
5
|
Baseline Characteristics
S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Ph I: Erlotinib + Gemcitabine + IMC-A12
n=9 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine + IMC-A12
n=57 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
n=59 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
63 years
n=7 Participants
|
64 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 participants
n=5 Participants
|
44 participants
n=7 Participants
|
51 participants
n=5 Participants
|
100 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
8 participants
n=5 Participants
|
53 participants
n=7 Participants
|
47 participants
n=5 Participants
|
108 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.
Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Outcome measures
| Measure |
Erlotinib + Gemcitabine + IMC-A12
n=10 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Maximum Tolerated Dose Determination
|
6 mg/kg IMC-A12
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients in the Phase II portion of the study.
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Outcome measures
| Measure |
Erlotinib + Gemcitabine + IMC-A12
n=57 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Erlotinib + Gemcitabine
n=59 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Progression-Free Survival
|
3.6 months
Interval 2.4 to 5.3
|
3.6 months
Interval 1.8 to 5.3
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients in the Phase II portion of the study.
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Erlotinib + Gemcitabine + IMC-A12
n=57 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Erlotinib + Gemcitabine
n=59 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Overall Survival
|
7.0 months
Interval 4.2 to 8.9
|
6.5 months
Interval 5.0 to 7.7
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients in the Phase II portion of the study with measurable disease and adequate response assessment.
Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Outcome measures
| Measure |
Erlotinib + Gemcitabine + IMC-A12
n=51 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Erlotinib + Gemcitabine
n=53 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Response
|
13.7 percentage of participants
Interval 5.7 to 26.3
|
15.3 percentage of participants
Interval 7.2 to 27.0
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Erlotinib + Gemcitabine + IMC-A12
n=9 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Erlotinib + Gemcitabine
n=57 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
n=57 Participants
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Toxicity
Ventricular arrhythmia - Ventricular fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Acidosis (metabolic or respiratory)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Adult respiratory distress syndrome (ARDS)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Cardiac-ischemia/infarction
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Cardiopulmonary arrest, cause unknown (non-fatal)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Dehydration
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Toxicity
Diarrhea
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Toxicity
Dyspnea (shortness of breath)
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Toxicity
Edema: limb
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Fatigue (asthenia, lethargy, malaise)
|
4 Participants
|
16 Participants
|
12 Participants
|
|
Toxicity
GGT (gamma-glutamyl transpeptidase)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Glucose, serum-high (hyperglycemia)
|
2 Participants
|
16 Participants
|
1 Participants
|
|
Toxicity
Hypotension
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Toxicity
Hypoxia
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Pancreas
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Muscle weakness, not d/t neuropathy - body/general
|
0 Participants
|
5 Participants
|
3 Participants
|
|
Toxicity
PTT (Partial thromboplastin time)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Personality/behavioral
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Platelets
|
2 Participants
|
16 Participants
|
7 Participants
|
|
Toxicity
Sodium, serum-low (hyponatremia)
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Toxicity
Vision-blurred vision
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Vision-photophobia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Vomiting
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Toxicity
Weight loss
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0 Participants
|
9 Participants
|
4 Participants
|
|
Toxicity
AST, SGOT
|
0 Participants
|
6 Participants
|
3 Participants
|
|
Toxicity
Albumin, serum-low (hypoalbuminemia)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Toxicity
Alkaline phosphatase
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Toxicity
Allergic reaction/hypersensitivity
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity
Anorexia
|
1 Participants
|
7 Participants
|
6 Participants
|
|
Toxicity
Bilirubin (hyperbilirubinemia)
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Toxicity
Calcium, serum-low (hypocalcemia)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity
Cardiac troponin I (cTnI)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Toxicity
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Dysphagia (difficulty swallowing)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Edema: trunk/genital
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Hemoglobin
|
0 Participants
|
9 Participants
|
8 Participants
|
|
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Inf w/normal ANC or Gr 1-2 neutrophils -Up aerodig
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Infection-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Left ventricular systolic dysfunction
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Leukocytes (total WBC)
|
1 Participants
|
9 Participants
|
5 Participants
|
|
Toxicity
Liver dysfunction/failure (clinical)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Lymphatics-Other (Specify)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Lymphopenia
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Toxicity
Magnesium, serum-low (hypomagnesemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Mucositis/stomatitis (functional/symp) - Oral cav
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Muscle weakness, not d/t neuropathy - Extrem-lower
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Nausea
|
4 Participants
|
9 Participants
|
6 Participants
|
|
Toxicity
Neuropathy: sensory
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Neutrophils/granulocytes (ANC/AGC)
|
3 Participants
|
21 Participants
|
10 Participants
|
|
Toxicity
Obstruction, GI - Duodenum
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity
Pain - Abdomen NOS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Pain - Eye
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Pain - Head/headache
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Pain - Muscle
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Pancreas, exocrine enzyme deficiency
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Pancreatic endocrine: glucose intolerance
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Toxicity
Pericardial effusion (non-malignant)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Pleural effusion (non-malignant)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Pneumonitis/pulmonary infiltrates
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Toxicity
Potassium, serum-low (hypokalemia)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Toxicity
Rash/desquamation
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Rash: acne/acneiform
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Toxicity
Rash: erythema multiforme
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
SVT and nodal arrhythmia - Atrial fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Stricture/stenosis (incl anastomotic), Stomach
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity
Syncope (fainting)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Toxicity
Thrombosis/embolism (vascular access-related)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Thrombosis/thrombus/embolism
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Toxicity
Tremor
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity
Uric acid, serum-high (hyperuricemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Ph I: Erlotinib + Gemcitabine + IMC-A12
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Ph II: Erlotinib + Gemcitabine + IMC-A12
Serious events: 34 serious events
Other events: 56 other events
Deaths: 0 deaths
Ph II: Erlotinib + Gemcitabine
Serious events: 33 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ph I: Erlotinib + Gemcitabine + IMC-A12
n=9 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine + IMC-A12
n=57 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
n=57 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Blood and lymphatic system disorders
Lymphatics-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Cardiac disorders
Atrioventricular block - first degree
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular fibrillation
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Duodenum
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Gastrointestinal disorders
Obstruction, GI - Duodenum
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Gastrointestinal disorders
Obstruction, GI - Stomach
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/9 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
General disorders
Edema: limb
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.1%
1/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Hepatobiliary disorders
Portal vein flow
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Hepatobiliary disorders
Stricture/stenosis (incl anastomotic)-Biliary tree
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Pancreas
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils -Up aerodig
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Investigations
AST, SGOT
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Investigations
Amylase
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Investigations
Creatinine
|
11.1%
1/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Lipase
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Lymphopenia
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Pancreas, exocrine enzyme deficiency
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Platelets
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
Weight loss
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
44.4%
4/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
11.1%
1/9 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - agitation
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Personality/behavioral
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/9 • Up to 3 years
|
1.8%
1/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Up to 3 years
|
3.5%
2/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
Other adverse events
| Measure |
Ph I: Erlotinib + Gemcitabine + IMC-A12
n=9 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine + IMC-A12
n=57 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
|
Ph II: Erlotinib + Gemcitabine
n=57 participants at risk
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m\^2 IV days 1, 8 and 15. One cycle = 28 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.9%
8/9 • Up to 3 years
|
66.7%
38/57 • Up to 3 years
|
68.4%
39/57 • Up to 3 years
|
|
Cardiac disorders
Cardiac Arrhythmia-Other (Specify)
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial tachycardia/PAT
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Ear and labyrinth disorders
Auditory/Ear-Other (Specify)
|
22.2%
2/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Eye disorders
Dry eye syndrome
|
11.1%
1/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Eye disorders
Vision-flashing lights/floaters
|
33.3%
3/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
77.8%
7/9 • Up to 3 years
|
57.9%
33/57 • Up to 3 years
|
47.4%
27/57 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Up to 3 years
|
56.1%
32/57 • Up to 3 years
|
47.4%
27/57 • Up to 3 years
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
11.1%
1/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
33.3%
3/9 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Abdomen NOS
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
1/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
11.1%
1/9 • Up to 3 years
|
29.8%
17/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
22.2%
2/9 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
9/9 • Up to 3 years
|
75.4%
43/57 • Up to 3 years
|
59.6%
34/57 • Up to 3 years
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
55.6%
5/9 • Up to 3 years
|
29.8%
17/57 • Up to 3 years
|
36.8%
21/57 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Rectum
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Pain - Stomach
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
6/9 • Up to 3 years
|
45.6%
26/57 • Up to 3 years
|
43.9%
25/57 • Up to 3 years
|
|
General disorders
Edema: limb
|
11.1%
1/9 • Up to 3 years
|
21.1%
12/57 • Up to 3 years
|
28.1%
16/57 • Up to 3 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
88.9%
8/9 • Up to 3 years
|
82.5%
47/57 • Up to 3 years
|
75.4%
43/57 • Up to 3 years
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
33.3%
3/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
26.3%
15/57 • Up to 3 years
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
General disorders
Pain-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
General disorders
Rigors/chills
|
11.1%
1/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Immune system disorders
Allergy/Immunology-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
22.2%
2/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Infections and infestations
Infection-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Infections and infestations
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
22.2%
2/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
88.9%
8/9 • Up to 3 years
|
59.6%
34/57 • Up to 3 years
|
52.6%
30/57 • Up to 3 years
|
|
Investigations
AST, SGOT
|
88.9%
8/9 • Up to 3 years
|
63.2%
36/57 • Up to 3 years
|
54.4%
31/57 • Up to 3 years
|
|
Investigations
Alkaline phosphatase
|
55.6%
5/9 • Up to 3 years
|
61.4%
35/57 • Up to 3 years
|
43.9%
25/57 • Up to 3 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
33.3%
3/9 • Up to 3 years
|
31.6%
18/57 • Up to 3 years
|
31.6%
18/57 • Up to 3 years
|
|
Investigations
Creatinine
|
33.3%
3/9 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
|
Investigations
INR (of prothrombin time)
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
|
Investigations
Leukocytes (total WBC)
|
44.4%
4/9 • Up to 3 years
|
50.9%
29/57 • Up to 3 years
|
50.9%
29/57 • Up to 3 years
|
|
Investigations
Lymphopenia
|
11.1%
1/9 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
66.7%
6/9 • Up to 3 years
|
52.6%
30/57 • Up to 3 years
|
35.1%
20/57 • Up to 3 years
|
|
Investigations
PTT (Partial thromboplastin time)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Investigations
Platelets
|
100.0%
9/9 • Up to 3 years
|
73.7%
42/57 • Up to 3 years
|
63.2%
36/57 • Up to 3 years
|
|
Investigations
Weight loss
|
33.3%
3/9 • Up to 3 years
|
47.4%
27/57 • Up to 3 years
|
43.9%
25/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
22.2%
2/9 • Up to 3 years
|
43.9%
25/57 • Up to 3 years
|
31.6%
18/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
55.6%
5/9 • Up to 3 years
|
61.4%
35/57 • Up to 3 years
|
54.4%
31/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
22.2%
2/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
22.2%
2/9 • Up to 3 years
|
31.6%
18/57 • Up to 3 years
|
24.6%
14/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Up to 3 years
|
21.1%
12/57 • Up to 3 years
|
19.3%
11/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
100.0%
9/9 • Up to 3 years
|
47.4%
27/57 • Up to 3 years
|
50.9%
29/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/9 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
22.2%
2/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Pancreatic endocrine: glucose intolerance
|
0.00%
0/9 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
22.2%
2/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
22.2%
2/9 • Up to 3 years
|
19.3%
11/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.1%
1/9 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
26.3%
15/57 • Up to 3 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
3/9 • Up to 3 years
|
33.3%
19/57 • Up to 3 years
|
33.3%
19/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
22.2%
2/9 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
22.2%
2/9 • Up to 3 years
|
22.8%
13/57 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
33.3%
3/9 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
11.1%
1/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
33.3%
3/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
12.3%
7/57 • Up to 3 years
|
|
Nervous system disorders
Neuropathy: sensory
|
11.1%
1/9 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Nervous system disorders
Ocular/Visual-Other (Specify)
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Nervous system disorders
Pain - Head/headache
|
11.1%
1/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
33.3%
3/9 • Up to 3 years
|
36.8%
21/57 • Up to 3 years
|
28.1%
16/57 • Up to 3 years
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
21.1%
12/57 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - agitation
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
11.1%
1/9 • Up to 3 years
|
19.3%
11/57 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
|
Psychiatric disorders
Mood alteration - depression
|
33.3%
3/9 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
5.3%
3/57 • Up to 3 years
|
|
Renal and urinary disorders
Renal failure
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • Up to 3 years
|
21.1%
12/57 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
22.2%
2/9 • Up to 3 years
|
26.3%
15/57 • Up to 3 years
|
35.1%
20/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
11.1%
1/9 • Up to 3 years
|
15.8%
9/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (clinical exam) - Pharynx
|
22.2%
2/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
11.1%
1/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
0.00%
0/9 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
6/9 • Up to 3 years
|
22.8%
13/57 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
11.1%
1/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
17.5%
10/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/9 • Up to 3 years
|
14.0%
8/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
22.2%
2/9 • Up to 3 years
|
21.1%
12/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.2%
2/9 • Up to 3 years
|
24.6%
14/57 • Up to 3 years
|
38.6%
22/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
66.7%
6/9 • Up to 3 years
|
54.4%
31/57 • Up to 3 years
|
42.1%
24/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
0.00%
0/57 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
11.1%
1/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • Up to 3 years
|
10.5%
6/57 • Up to 3 years
|
8.8%
5/57 • Up to 3 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/9 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
7.0%
4/57 • Up to 3 years
|
Additional Information
Study Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60