Trial Outcomes & Findings for A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer (NCT NCT00068380)

Last Updated: 2018-07-11

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2018-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Imatinib Mesylate) Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Overall Study STARTED	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Imatinib Mesylate) Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2

Baseline Characteristics

A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Response Rate	0 percentage of patients responding

PRIMARY outcome

Timeframe: Up to 30 days post treatment

Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Toxicity Summary Grade 3 : Alkaline phosphatase increased	1 Participants
Toxicity Summary Grade 3 : Anorexia	1 Participants
Toxicity Summary Grade 3 : Constipation	1 Participants
Toxicity Summary Grade 3 : Fatigue	1 Participants
Toxicity Summary Grade 3 : Hyperglycemia	1 Participants
Toxicity Summary Grade 3 : Hemoglobin decreased	1 Participants
Toxicity Summary Grade 3 : Hypoxia	1 Participants
Toxicity Summary Grade 3 : Abdominal pain	1 Participants
Toxicity Summary Grade 3 : Hypophosphatemia	2 Participants
Toxicity Summary Grade 3 : Hypokalemia	1 Participants
Toxicity Summary Grade 3 : Hyponatremia	1 Participants
Toxicity Summary Grade 3 : Packed red blood cell transfusion	3 Participants

PRIMARY outcome

Timeframe: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Progression-free Survival	1.35 Months Interval 0.72 to 1.81

PRIMARY outcome

Timeframe: From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment

Will be summarized using the Kaplan-Meier product-limit estimators.

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Overall Survival	3.25 Months Interval 1.84 to 5.49

PRIMARY outcome

Timeframe: From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment

Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Treatment (Imatinib Mesylate) n=17 Participants Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Time to Treatment Failure	0.98 Months Interval 0.46 to 1.45

PRIMARY outcome

Timeframe: Baseline

Population: Gene data were not collected. Due to budget constraints and recent reprioritizations, CTEP closed the study to accrual prior to collection of correlative data.

Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges - or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Imatinib Mesylate)

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Imatinib Mesylate) n=17 participants at risk Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin decreased	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Abdominal pain	17.6% 3/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Flatulence	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Gastrointestinal disorder	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders Fatigue	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders Fever	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders General symptom	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Creatinine increased	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Anorexia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Dehydration	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypoglycemia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Nervous system disorders Ischemia cerebrovascular	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Vascular disorders Hypotension	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.

Other adverse events

Other adverse events
Measure	Treatment (Imatinib Mesylate) n=17 participants at risk Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Haemorrhage NOS	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Blood and lymphatic system disorders Hemoglobin decreased	64.7% 11/17 • Number of events 17 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Blood and lymphatic system disorders Lymphangiopathy NOS	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Blood and lymphatic system disorders Packed red blood cell transfusion	17.6% 3/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Eye disorders Conjunctival disorder	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Eye disorders Eye disorder	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Eye disorders Vision blurred	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Abdominal pain	35.3% 6/17 • Number of events 6 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Ascites	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Diarrhea	23.5% 4/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Dry mouth	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Dyspepsia	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Esophagitis	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Gastrointestinal disorder	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Haematochezia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Melaena	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Nausea	64.7% 11/17 • Number of events 14 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Gastrointestinal disorders Vomiting	47.1% 8/17 • Number of events 9 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders Fatigue	58.8% 10/17 • Number of events 13 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders General symptom	58.8% 10/17 • Number of events 10 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders Oedema NOS	23.5% 4/17 • Number of events 7 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
General disorders Pain	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Alanine aminotransferase increased	23.5% 4/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Alkaline phosphatase increased	35.3% 6/17 • Number of events 8 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Aspartate aminotransferase increased	52.9% 9/17 • Number of events 12 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Creatinine increased	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Hyperbilirubinemia	23.5% 4/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Leukopenia	11.8% 2/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Lymphopenia	29.4% 5/17 • Number of events 6 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Neutrophil count decreased	11.8% 2/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Platelet count decreased	5.9% 1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Investigations Weight loss	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Anorexia	35.3% 6/17 • Number of events 9 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Dehydration	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hyperglycemia	17.6% 3/17 • Number of events 4 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hyperkalemia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypoalbuminemia	29.4% 5/17 • Number of events 9 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypocalcemia	23.5% 4/17 • Number of events 7 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypoglycemia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypokalemia	17.6% 3/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hyponatremia	17.6% 3/17 • Number of events 3 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Metabolism and nutrition disorders Hypophosphatemia	17.6% 3/17 • Number of events 5 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Joint pain	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	5.9% 1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Nervous system disorders Peripheral motor neuropathy	11.8% 2/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Nervous system disorders Speech disorder	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Psychiatric disorders Insomnia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Renal and urinary disorders Proteinuria	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Renal and urinary disorders Urinary retention	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Skin and subcutaneous tissue disorders Photosensitivity	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Skin and subcutaneous tissue disorders Rash desquamating	5.9% 1/17 • Number of events 2 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin discolouration	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin disorder	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Vascular disorders Hypertension	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.
Vascular disorders Thrombosis	5.9% 1/17 • Number of events 1 • Adverse events were collected over a period of 2 years, 2 months. "Other" adverse events include all grades and all attributions to treatment not included in "Serious" adverse events table.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60