Trial Outcomes & Findings for Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma (NCT NCT00510887)

Last Updated: 2014-05-12

Results Overview

* Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma. * Partial Response requires the following: * greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses. * No increase in size of other nodes, liver, or spleen. * Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD). * Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported. * No new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

1 year

Results posted on

2014-05-12

Participant Flow

Of the 14 subjects consented, 2 were screen failures so only 12 subjects received the study drug.

Participant milestones

Participant milestones
Measure	VR-FND Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	VR-FND Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Overall Study Lost to Follow-up	1

Baseline Characteristics

Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VR-FND n=14 Participants Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Age, Continuous	59 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	VR-FND n=11 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Complete and Partial Response	64 percentage of participants

SECONDARY outcome

Timeframe: up to 4 years

Duration of response is measured from time of treatment to time of disease progression

Outcome measures

Outcome measures
Measure	VR-FND n=7 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Duration of Response	16.47143 months Interval 3.4 to 43.0

SECONDARY outcome

Timeframe: up to 2 years

Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.

Outcome measures

Outcome measures
Measure	VR-FND n=11 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Percentage of Subjects Experiencing Progression Free Survival	17 percentage of participants

SECONDARY outcome

Timeframe: up to 2 years

Overall survival is from the day of enrollment to date of death from any cause.

Outcome measures

Outcome measures
Measure	VR-FND n=11 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Percentage of Subjects Experiencing Overall Survival	27 percentage of participants

SECONDARY outcome

Timeframe: up to 1 year

Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).

Outcome measures

Outcome measures
Measure	VR-FND n=11 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Number of Participants With a Grade 3-4 Hematologic Toxicity.	7 participants

SECONDARY outcome

Timeframe: up to 1 year

Outcome measures

Outcome measures
Measure	VR-FND n=11 Participants Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Number of Participants With Neuropathy, Any Grade	6 participants

Adverse Events

VR-FND

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VR-FND n=12 participants at risk Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle Rituximab: Rituximab 375 mg/m2 IV on day 1 Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5
Blood and lymphatic system disorders Blood / Bone Marrow - Other	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without documented infection)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Blood and lymphatic system disorders Low Hemoglobin	66.7% 8/12 • Number of events 9 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Ear and labyrinth disorders Auditory / Ear	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Eye disorders Vision - blurred vision	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Constipation	41.7% 5/12 • Number of events 9 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Diarrhea	33.3% 4/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Dry mouth / salivary gland (xerostomia)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Flatulence	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Heartburn / dyspepsia	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Mucositis / Stomatitis (clinical exam)	8.3% 1/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Nausea	66.7% 8/12 • Number of events 10 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Pain - Abdomen NOS	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Pain - Anus	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Pain - Dental / teeth / peridontal	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Gastrointestinal disorders Vomiting	41.7% 5/12 • Number of events 9 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Constitutional Symptoms - Other	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Edema: head and neck	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Edema: limb	41.7% 5/12 • Number of events 5 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Fatigue (asthenia, lethargy, malaise)	83.3% 10/12 • Number of events 17 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Pain - Chest / thorax NOS	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
General disorders Rigors / chills	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Hepatobiliary disorders Pain - Gallbladder	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Infections and infestations Infection - Other	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Infections and infestations Infection with unknown ANC - Mucosa	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Injury, poisoning and procedural complications Bruising (in absence of Grade 3 or 4 thrombocytopenia)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations High Alkaline phosphatase	33.3% 4/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations High AST, SGOT (serum glutamic oxaloacetic transaminase)	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Bilirubin (hyperbilirubinemia)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations High Creatinine	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Low Leukocytes (total WBC)	83.3% 10/12 • Number of events 15 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Lymphopenia	41.7% 5/12 • Number of events 5 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Metabolic / Laboratory - Other	25.0% 3/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Low Neutrophils / granulocytes (ANC / AGC)	58.3% 7/12 • Number of events 11 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Low Platelets	75.0% 9/12 • Number of events 10 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Investigations Weight loss	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Anorexia	50.0% 6/12 • Number of events 10 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	41.7% 5/12 • Number of events 7 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Dehydration	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	50.0% 6/12 • Number of events 9 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Tumor lysis syndrome	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Metabolism and nutrition disorders Uric Acid, serum-high (hyperuricemia)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Joint-function	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal - Flank pain	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Pain - Back	41.7% 5/12 • Number of events 5 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Pain - Bone	8.3% 1/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	8.3% 1/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Musculoskeletal and connective tissue disorders Pain - Joint	25.0% 3/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Nervous system disorders Dizziness	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Nervous system disorders Neuropathy: motor	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Nervous system disorders Neuropathy: sensory	41.7% 5/12 • Number of events 5 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Nervous system disorders Pain - Head / headache	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Nervous system disorders Taste Alteration (dysgeusia)	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Psychiatric disorders Insomnia	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Psychiatric disorders Mood Alteration - Agitation	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Renal and urinary disorders Pain - Kidney	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Renal and urinary disorders Renal / Genitourinary - Other	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 4/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	33.3% 4/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Respiratory, thoracic and mediastinal disorders Pain - Throat / pharynx / larynx	25.0% 3/12 • Number of events 4 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Dry Skin	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Nail Changes	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Petechiae / purpura (hemorrhage / bleeding into skin or mucosa)	8.3% 1/12 • Number of events 1 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Pruritus / itching	25.0% 3/12 • Number of events 3 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Rash / desquamation	33.3% 4/12 • Number of events 6 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	41.7% 5/12 • Number of events 6 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.
Vascular disorders Hypotension	16.7% 2/12 • Number of events 2 • From first dose of study drug to 30 days after the last dose of study drug All adverse events are reported whether or not they are considered attributable to the study treatment.

Additional Information

Dr. David Rizzieri

Duke University Medical Center

Phone: 919-668-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place