Trial Outcomes & Findings for PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery (NCT NCT00365053)

Last Updated: 2018-06-07

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: 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

13 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2018-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Belinostat) Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Belinostat) n=13 Participants Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Age, Continuous	73 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Treatment (Belinostat) n=13 Participants Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat) n=13 Participants Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival	4.5 Months Interval 2.3 to 5.3

SECONDARY outcome

Timeframe: Up to 3 years

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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 (Belinostat) n=13 Participants Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Progression-free Survival	1.2 Months Interval 1.1 to 1.6

SECONDARY outcome

Timeframe: Up to 3 years

Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat) n=13 Participants Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Toxicity Profile Grade 2 : Hemoglobin	6 Participants
Toxicity Profile Grade 2 : Lymphopenia	1 Participants
Toxicity Profile Grade 2 : Albumin	1 Participants
Toxicity Profile Grade 2 : Anorexia	2 Participants
Toxicity Profile Grade 2 : AST	0 Participants
Toxicity Profile Grade 2 : Constipation	2 Participants
Toxicity Profile Grade 2 : Creatinine	1 Participants
Toxicity Profile Grade 2 : Sweating	1 Participants
Toxicity Profile Grade 2 : Dyspnea	3 Participants
Toxicity Profile Grade 2 : Fatigue	0 Participants
Toxicity Profile Grade 2 : Glucose (hyperglycemia)	6 Participants
Toxicity Profile Grade 2 : Hypoxia	0 Participants
Toxicity Profile Grade 2 : Hypotension	1 Participants
Toxicity Profile Grade 2 : Infection	2 Participants
Toxicity Profile Grade 2 : Nausea	2 Participants
Toxicity Profile Grade 2 : Pain	1 Participants
Toxicity Profile Grade 2 : Sodium (Hyponatremia)	0 Participants
Toxicity Profile Grade 2 : Supraventricular arrhythmia NOS	2 Participants
Toxicity Profile Grade 3 : Hemoglobin	0 Participants
Toxicity Profile Grade 3 : Lymphopenia	0 Participants
Toxicity Profile Grade 3 : Albumin	0 Participants
Toxicity Profile Grade 3 : Anorexia	0 Participants
Toxicity Profile Grade 3 : AST	1 Participants
Toxicity Profile Grade 3 : Constipation	0 Participants
Toxicity Profile Grade 3 : Creatinine	0 Participants
Toxicity Profile Grade 3 : Sweating	0 Participants
Toxicity Profile Grade 3 : Dyspnea	1 Participants
Toxicity Profile Grade 3 : Fatigue	2 Participants
Toxicity Profile Grade 3 : Glucose (hyperglycemia)	0 Participants
Toxicity Profile Grade 3 : Hypoxia	0 Participants
Toxicity Profile Grade 3 : Hypotension	0 Participants
Toxicity Profile Grade 3 : Infection	0 Participants
Toxicity Profile Grade 3 : Nausea	0 Participants
Toxicity Profile Grade 3 : Pain	0 Participants
Toxicity Profile Grade 3 : Sodium (Hyponatremia)	3 Participants
Toxicity Profile Grade 3 : Supraventricular arrhythmia NOS	1 Participants
Toxicity Profile Grade 4 : Hemoglobin	0 Participants
Toxicity Profile Grade 4 : Lymphopenia	0 Participants
Toxicity Profile Grade 4 : Albumin	0 Participants
Toxicity Profile Grade 4 : Anorexia	0 Participants
Toxicity Profile Grade 4 : AST	0 Participants
Toxicity Profile Grade 4 : Constipation	0 Participants
Toxicity Profile Grade 4 : Creatinine	0 Participants
Toxicity Profile Grade 4 : Sweating	0 Participants
Toxicity Profile Grade 4 : Dyspnea	1 Participants
Toxicity Profile Grade 4 : Fatigue	0 Participants
Toxicity Profile Grade 4 : Glucose (hyperglycemia)	0 Participants
Toxicity Profile Grade 4 : Hypoxia	1 Participants
Toxicity Profile Grade 4 : Hypotension	0 Participants
Toxicity Profile Grade 4 : Infection	0 Participants
Toxicity Profile Grade 4 : Nausea	0 Participants
Toxicity Profile Grade 4 : Pain	0 Participants
Toxicity Profile Grade 4 : Sodium (Hyponatremia)	0 Participants
Toxicity Profile Grade 4 : Supraventricular arrhythmia NOS	0 Participants

SECONDARY outcome

Timeframe: At baseline

Population: Assay data were not collected.

Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and at 4 hours after last dose of PXD101 on day 5

Population: IHC data were not collected.

Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Belinostat)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Belinostat) n=13 participants at risk Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Cardiac disorders Supraventricular tachycardia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Chest pain	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Death	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.

Other adverse events

Other adverse events
Measure	Treatment (Belinostat) n=13 participants at risk Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin decreased	61.5% 8/13 • Number of events 11 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Atrial flutter	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Cardiac valve disease	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Myocardial ischemia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Palpitations	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Premature ventricular contractions	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Sinus arrhythmia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Supraventricular tachycardia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 3 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Constipation	61.5% 8/13 • Number of events 13 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Diarrhea	23.1% 3/13 • Number of events 3 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Nausea	76.9% 10/13 • Number of events 15 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Vomiting	53.8% 7/13 • Number of events 9 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Chest pain	23.1% 3/13 • Number of events 4 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Disease progression	69.2% 9/13 • Number of events 9 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Edema limbs	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fatigue	76.9% 10/13 • Number of events 16 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fever	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Injection site reaction	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Localized edema	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Pain	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Immune system disorders Hypersensitivity	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Peripheral nerve infection	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Injury, poisoning and procedural complications Prolonged intubation after pulmonary resection (>24 hrs after surgery)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 3 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Alkaline phosphatase increased	30.8% 4/13 • Number of events 5 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Aspartate aminotransferase increased	23.1% 3/13 • Number of events 4 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Creatinine increased	30.8% 4/13 • Number of events 4 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Haptoglobin decreased	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Lymphocyte count decreased	23.1% 3/13 • Number of events 3 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Lymphopenia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Weight loss	38.5% 5/13 • Number of events 8 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Alkalosis	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Anorexia	53.8% 7/13 • Number of events 9 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hyperglycemia	61.5% 8/13 • Number of events 8 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hypoalbuminemia	30.8% 4/13 • Number of events 5 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hypomagnesemia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Hyponatremia	23.1% 3/13 • Number of events 4 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum albumin decreased	23.1% 3/13 • Number of events 7 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum calcium increased	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum magnesium decreased	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum potassium decreased	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum sodium decreased	15.4% 2/13 • Number of events 6 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Back pain	23.1% 3/13 • Number of events 9 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Muscle weakness	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	23.1% 3/13 • Number of events 4 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Depressed level of consciousness	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Headache	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Anxiety	23.1% 3/13 • Number of events 3 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Depression	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Psychosis	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Protein urine positive	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urinary frequency	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urine discoloration	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Bronchospasm	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Dyspnea	69.2% 9/13 • Number of events 19 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Voice alteration	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Alopecia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Pain of skin	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Rash desquamating	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Sweating	23.1% 3/13 • Number of events 5 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hypertension	7.7% 1/13 • Number of events 2 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Phlebitis superficial	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of 1 year, 1 month. "Other" adverse events table includes all grades and attributions to treatment not included in the "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