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IIT CTI Bendamustine, Rituximab, Pixantrone in Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma (BRP)

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ClinicalTrials.gov Identifier: NCT01491841
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : June 14, 2019
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
Anne Beaven, MD, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Interventions Drug: Bendamustine + Rituximab + Pixantrone
Drug: Pegfilgrastim
Enrollment 33
Recruitment Details The study opened November 1, 2011 and closed to accrual September 22, 2016. Subjects were recruited through the Hematology Clinic at Duke University Medical Center.
Pre-assignment Details  
Arm/Group Title Bendamustine + Rituximab + Pixantrone
Hide Arm/Group Description

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD (maximum tolerated dose); to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Period Title: Overall Study
Started 33
Completed 22
Not Completed 11
Reason Not Completed
Screen Failure             10
Withdrawal by Subject             1
Arm/Group Title Bendamustine + Rituximab + Pixantrone
Hide Arm/Group Description

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  57.6%
>=65 years
14
  42.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
10
  30.3%
Male
23
  69.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
33
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.1%
White
31
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
 100.0%
1.Primary Outcome
Title Maximum Tolerated Dose
Hide Description Dose-limiting toxicity (DLT) assessments were performed weekly during cycles 1 and 2. A DLT was defined as any grade 3 non-hematologic toxicity that lasted longer than 48 hours, despite proper supportive care, any grade 4 non-hematologic toxicity, or any grade 3 or 4 hematologic toxicity lasting longer than 7 days. Alopecia and febrile neutropenia were not considered DLTs. Any NCI CTC (National Cancer Institute Common Terminology Criteria) v4.03 grade 5 (death) toxicity was considered a DLT. Dose Limiting Toxicities were used as the assessment criteria to determine the Maximum Tolerated Dose (MTD). MTD is presented.
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Over the course of 4 years, dose escalation was performed in 3 cohorts. Cohort 1 (Phase 1: Pixantrone, 55mg/m^2) enrolled 7 people; Cohort 2 (Phase 1: Pixantrone, 85mg/m^2) enrolled 7 people; Cohort 3 (Phase 1: Pixantrone, 115 mg/m^2) enrolled 7 people.
Arm/Group Title Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
Hide Arm/Group Description:

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: milligrams per meter squared
115
2.Secondary Outcome
Title Overall Response
Hide Description

Partial response and complete response evaluated using a modified version of the revised response criteria for malignant lymphoma by Cheson et al

Complete Response (CR) • Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.

Complete Response Unconfirmed (CRu) meets the CR criteria, but with one or more of the following:

  • A residual node > 1.5 cm in greatest transverse diameter that has regressed >75% in the sum of the product of the diameters (SPD). Individual nodes that were previously confluent must have regressed >75% in their SPD compared with the size of the original mass.
  • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia by immunohistochemistry or flow cytometry).

Partial Response (PR)

• A decrease of ≥ 50% in the SPD of up to six of the largest dominant nodes or nodal masses.

Time Frame up to 220 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
Arm/Group Title Pixantrone, 55mg/m^2 Pixantrone, 85mg/m^2 Pixantrone, 115mg/m^2
Hide Arm/Group Description:

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
2
  66.7%
5
  71.4%
3.Secondary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame From day 1 of treatment to disease progression, death or 5 years, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.
Arm/Group Title Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
Hide Arm/Group Description:

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(1.3 to 6.9)
4.Secondary Outcome
Title Toxicity
Hide Description Dose limiting toxicities plus % of patients with a clinically significant change in left ventricular ejection fraction.
Time Frame 30 days post last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 subjects who received study drugs.
Arm/Group Title Phase 1: Pixantrone, 55mg/m^2 Phase 1: Pixantrone, 85mg/m^2 Phase 1: Pixantrone, 115mg/m^2
Hide Arm/Group Description:

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Participants Analyzed 7 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
Dose-Limiting Toxicity
1
  14.3%
1
  14.3%
1
  14.3%
Left Ventricular Ejection Fraction
1
  14.3%
0
   0.0%
0
   0.0%
Other Adverse Events
6
  85.7%
6
  85.7%
6
  85.7%
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame from day 1 of treatment to death
Hide Outcome Measure Data
Hide Analysis Population Description
Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.
Arm/Group Title Bendamustine + Rituximab + Pixantrone + Pegfilgrastim
Hide Arm/Group Description:

Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, variable dosing depending on the cohort and MTD; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle

Bendamustine + Rituximab + Pixantrone: Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(4.2 to 15.4)
Time Frame Up to 220 days
Adverse Event Reporting Description Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.
 
Arm/Group Title Pixantrone, 55mg/m^2 Pixantrone, 85mg/m^2 Pixantrone, 115mg/m^2
Hide Arm/Group Description Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 55mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 85mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle Bendamustine, 120mg/m2; administered first on Day 1 of each cycle. Rituximab, 375mg/m2; administered second on Day 1 of each cycle. Pixantrone, 115mg/m2; to be administered last, 4-6 hours after bendamustine, on Day 1 of each cycle Pegfilgrastim, 6mg; administered on Day 2 of each cycle
All-Cause Mortality
Pixantrone, 55mg/m^2 Pixantrone, 85mg/m^2 Pixantrone, 115mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/7 (85.71%)   7/7 (100.00%)   8/8 (100.00%) 
Hide Serious Adverse Events
Pixantrone, 55mg/m^2 Pixantrone, 85mg/m^2 Pixantrone, 115mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   0/7 (0.00%)   2/8 (25.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Cardiac disorders       
Left ventricular systolic dysfunction * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders       
Hypercalcemia * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders       
Acute kidney injury * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Vascular disorders       
Hypotension * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pixantrone, 55mg/m^2 Pixantrone, 85mg/m^2 Pixantrone, 115mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   7/7 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders       
Anemia * 1  2/7 (28.57%)  0/7 (0.00%)  5/8 (62.50%) 
Febrile neutropenia * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Cardiac disorders       
Atrial fibrillation * 1  0/7 (0.00%)  1/7 (14.29%)  1/8 (12.50%) 
Cardiac disorders - Other, specify * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Chest pain - cardiac * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Sinus tachycardia * 1  0/7 (0.00%)  0/7 (0.00%)  4/8 (50.00%) 
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other, specify * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Eye disorders       
Dry eye * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Watering eyes * 1  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Bloating * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Constipation * 1  3/7 (42.86%)  1/7 (14.29%)  1/8 (12.50%) 
Diarrhea * 1  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Dry mouth * 1  0/7 (0.00%)  0/7 (0.00%)  3/8 (37.50%) 
Dyspepsia * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Gastroesophageal reflux disease * 1  1/7 (14.29%)  0/7 (0.00%)  2/8 (25.00%) 
Mucositis oral * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Nausea * 1  4/7 (57.14%)  1/7 (14.29%)  3/8 (37.50%) 
Oral pain * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Vomiting * 1  2/7 (28.57%)  0/7 (0.00%)  4/8 (50.00%) 
General disorders       
Edema limbs * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Fatigue * 1  5/7 (71.43%)  2/7 (28.57%)  6/8 (75.00%) 
Fever * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Gait disturbance * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
General disorders and administration site conditions - Other, specify * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Infusion site extravasation * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Injection site reaction * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Localized edema * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Malaise * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Non-cardiac chest pain * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Pain * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Infections and infestations       
Gum infection * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Investigations       
Alanine aminotransferase increased * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Alkaline phosphatase increased * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Aspartate aminotransferase increased * 1  0/7 (0.00%)  0/7 (0.00%)  3/8 (37.50%) 
Creatinine increased * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Electrocardiogram QT corrected interval prolonged * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Neutrophil count decreased * 1  1/7 (14.29%)  1/7 (14.29%)  4/8 (50.00%) 
Platelet count decreased * 1  2/7 (28.57%)  0/7 (0.00%)  5/8 (62.50%) 
Urine output decreased * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Weight loss * 1  2/7 (28.57%)  0/7 (0.00%)  0/8 (0.00%) 
White blood cell decreased * 1  0/7 (0.00%)  0/7 (0.00%)  3/8 (37.50%) 
Metabolism and nutrition disorders       
Anorexia * 1  4/7 (57.14%)  2/7 (28.57%)  1/8 (12.50%) 
Hypercalcemia * 1  2/7 (28.57%)  0/7 (0.00%)  2/8 (25.00%) 
Hyperglycemia * 1  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Hypoalbuminemia * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Hypocalcemia * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Hypokalemia * 1  0/7 (0.00%)  0/7 (0.00%)  3/8 (37.50%) 
Hypomagnesemia * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Hyponatremia * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Musculoskeletal and connective tissue disorders       
Abdominal soft tissue necrosis * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Back pain * 1  0/7 (0.00%)  0/7 (0.00%)  5/8 (62.50%) 
Bone pain * 1  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Neck pain * 1  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Pain in extremity * 1  3/7 (42.86%)  0/7 (0.00%)  1/8 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Nervous system disorders       
Dizziness * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Dysgeusia * 1  1/7 (14.29%)  0/7 (0.00%)  2/8 (25.00%) 
Paresthesia * 1  0/7 (0.00%)  0/7 (0.00%)  4/8 (50.00%) 
Psychiatric disorders       
Anxiety * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Depression * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Psychiatric disorders - Other, specify * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders       
Hematuria * 1  0/7 (0.00%)  1/7 (14.29%)  1/8 (12.50%) 
Proteinuria * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Urinary retention * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Urine discoloration * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Reproductive system and breast disorders       
Gynecomastia * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Reproductive system and breast disorders - Other, specify * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/7 (0.00%)  0/7 (0.00%)  3/8 (37.50%) 
Dyspnea * 1  3/7 (42.86%)  1/7 (14.29%)  3/8 (37.50%) 
Epistaxis * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Pleural effusion * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Postnasal drip * 1  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Dry skin * 1  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Rash maculo-papular * 1  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Rizzieri, MD
Organization: Duke University Medical Center
Phone: 919-668-1040
EMail: david.rizzieri@duke.edu
Layout table for additonal information
Responsible Party: Anne Beaven, MD, Duke University
ClinicalTrials.gov Identifier: NCT01491841    
Other Study ID Numbers: Pro00030834
First Submitted: November 14, 2011
First Posted: December 14, 2011
Results First Submitted: May 22, 2017
Results First Posted: June 14, 2019
Last Update Posted: March 4, 2020