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Trial record 17 of 36 for:    "Viral Infectious Disease" | "Everolimus"

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00918333
Recruitment Status : Active, not recruiting
First Posted : June 11, 2009
Results First Posted : May 18, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Primary Central Nervous System Non-Hodgkin Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Multiple Myeloma
Splenic Marginal Zone Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
Waldenström Macroglobulinemia
Interventions Drug: panobinostat
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus)
Hide Arm/Group Description Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 26 98
Completed 23 93
Not Completed 3 5
Reason Not Completed
Drug not taken per protocol             1             0
Inadequate amount of drugs provided             1             4
Ineligible             1             0
Withdrawal by Subject             0             1
Arm/Group Title Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus) Total
Hide Arm/Group Description Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 23 93 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 93 participants 116 participants
61.0
(24.0 to 73.0)
59.0
(20.0 to 84.0)
59.5
(20.0 to 84.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 93 participants 116 participants
Female
6
  26.1%
28
  30.1%
34
  29.3%
Male
17
  73.9%
65
  69.9%
82
  70.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 93 participants 116 participants
23
 100.0%
93
 100.0%
116
 100.0%
1.Primary Outcome
Title Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
Hide Description The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).
Arm/Group Title Phase I (Panobinostat + Everolimus)
Hide Arm/Group Description:
Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I (Panobinostat + Everolimus)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Maximum Tolerated Dose (mg)
Estimated Value 40
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Response Rate (Phase II)
Hide Description For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h), or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Time Frame Up to 12 courses
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Arm/Group Title Phase II (Lymphoma Patients Receiving 20 mg LBL589) Phase II (Myeloma Patients Receiving 20 mg LBH589) Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Hide Arm/Group Description:
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 41 14 20 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
39
(23 to 53)
7
(0 to 34)
20
(2 to 31)
0
(0 to 19)
3.Secondary Outcome
Title Overall Survival Time (Phase II)
Hide Description Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
Time Frame Time from registration to death due to any cause, assessed up to 2 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Arm/Group Title Phase II (Lymphoma Patients Receiving 20 mg LBL589) Phase II (Myeloma Patients Receiving 20 mg LBH589) Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Hide Arm/Group Description:
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 41 14 20 18
Median (95% Confidence Interval)
Unit of Measure: months
17.1 [1] 
(7.0 to NA)
16.6 [1] 
(9.7 to NA)
35.4 [1] 
(11.5 to NA)
21.7
(12.1 to 47.6)
[1]
The upper bound of the 95% confidence interval has not yet been reached.
4.Secondary Outcome
Title Progression-free Survival (Phase II)
Hide Description Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
Time Frame Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Arm/Group Title Phase II (Lymphoma Patients Receiving 20 mg LBL589) Phase II (Myeloma Patients Receiving 20 mg LBH589) Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Hide Arm/Group Description:
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 41 14 20 18
Median (95% Confidence Interval)
Unit of Measure: months
3.7
(2.1 to 8.3)
2.3 [1] 
(1.0 to NA)
4.2
(3.0 to 9.6)
4.3
(3.9 to 5.8)
[1]
The upper bound of the 95% confidence interval has not yet been reached.
5.Secondary Outcome
Title Duration of Response (Phase II)
Hide Description Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.
Time Frame The time from the date at which the patient’s objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
Arm/Group Title Phase II (Lymphoma Patients Receiving 20 mg LBL589) Phase II (Myeloma Patients Receiving 20 mg LBH589) Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
Hide Arm/Group Description:
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 16 1 4
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(6.5 to 33.5)
NA [1] 
(NA to NA)
12.9
(4.2 to 30.4)
[1]
The median and upper bound of the 95% confidence interval have not yet been reached.
6.Other Pre-specified Outcome
Title Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters
Hide Description Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher’s exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
Time Frame Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Changes in Biological Markers
Hide Description Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher’s exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.
Time Frame Baseline to up to 12 courses
Outcome Measure Data Not Reported
Time Frame Assessed during treatment phase on day 1 of cycles 2-13 and then every 3 cycles; up to 52 months.
Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
 
Arm/Group Title Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus)
Hide Arm/Group Description Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      1/93 (1.08%)    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/23 (13.04%)      25/93 (26.88%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Hemoglobin decreased  1  0/23 (0.00%)  0 2/93 (2.15%)  3
Cardiac disorders     
Supraventricular tachycardia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Gastrointestinal disorders     
Diarrhea  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Ear, nose and throat examination abnormal  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Gastric perforation  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Ileal hemorrhage  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Mucositis oral  1  0/23 (0.00%)  0 1/93 (1.08%)  1
General disorders     
Fatigue  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Ill-defined disorder  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Infections and infestations     
Infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pneumonia  1  1/23 (4.35%)  1 3/93 (3.23%)  4
Sepsis  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Skin infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Upper respiratory infection  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Investigations     
Creatinine increased  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Leukocyte count decreased  1  1/23 (4.35%)  1 2/93 (2.15%)  2
Lymphocyte count decreased  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Neutrophil count decreased  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Platelet count decreased  1  1/23 (4.35%)  1 5/93 (5.38%)  6
Metabolism and nutrition disorders     
Dehydration  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Serum calcium increased  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Serum triglycerides increased  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Nervous system disorders     
Dizziness  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Syncope  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Renal and urinary disorders     
Renal failure  1  1/23 (4.35%)  1 1/93 (1.08%)  1
Urogenital disorder  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Dyspnea  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Hemorrhage nasal  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Hypoxia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pneumonitis  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Skin and subcutaneous tissue disorders     
Rash desquamating  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Skin ulceration  1  0/23 (0.00%)  0 1/93 (1.08%)  1
1
Term from vocabulary, MedDRA 6
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I (Panobinostat + Everolimus) Phase II (Panobinostat + Everolimus)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/23 (100.00%)      92/93 (98.92%)    
Blood and lymphatic system disorders     
Blood disorder  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Hemoglobin decreased  1  22/23 (95.65%)  167 91/93 (97.85%)  349
Cardiac disorders     
Palpitations  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Sinus tachycardia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Eye disorders     
Keratitis  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Gastrointestinal disorders     
Constipation  1  0/23 (0.00%)  0 2/93 (2.15%)  3
Diarrhea  1  15/23 (65.22%)  76 54/93 (58.06%)  204
Dry mouth  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Dyspepsia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Ear, nose and throat examination abnormal  1  16/23 (69.57%)  71 52/93 (55.91%)  101
Esophageal pain  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Gingival pain  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Nausea  1  10/23 (43.48%)  28 41/93 (44.09%)  112
Oral pain  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Upper gastrointestinal hemorrhage  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Vomiting  1  4/23 (17.39%)  5 30/93 (32.26%)  47
General disorders     
Chills  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Edema limbs  1  1/23 (4.35%)  1 3/93 (3.23%)  4
Fatigue  1  21/23 (91.30%)  126 83/93 (89.25%)  346
Fever  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Localized edema  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Pain  1  0/23 (0.00%)  0 2/93 (2.15%)  3
Immune system disorders     
Hypersensitivity  1  0/23 (0.00%)  0 1/93 (1.08%)  2
Infections and infestations     
Bone infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Bronchitis  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Catheter related infection  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Infection  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Lip infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Mucosal infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Opportunistic infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Otitis externa  1  1/23 (4.35%)  2 0/93 (0.00%)  0
Pharyngitis  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pneumonia  1  4/23 (17.39%)  6 2/93 (2.15%)  2
Sepsis  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Sinusitis  1  2/23 (8.70%)  4 2/93 (2.15%)  4
Skin infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Small intestine infection  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Upper respiratory infection  1  1/23 (4.35%)  1 3/93 (3.23%)  4
Urinary tract infection  1  0/23 (0.00%)  0 2/93 (2.15%)  3
Investigations     
Activated partial thromboplastin time prolonged  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Alkaline phosphatase increased  1  0/23 (0.00%)  0 6/93 (6.45%)  10
Aspartate aminotransferase increased  1  0/23 (0.00%)  0 4/93 (4.30%)  4
Creatine phosphokinase increased  1  0/23 (0.00%)  0 1/93 (1.08%)  2
Creatinine increased  1  0/23 (0.00%)  0 8/93 (8.60%)  9
INR increased  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Leukocyte count decreased  1  20/23 (86.96%)  86 69/93 (74.19%)  156
Lymphocyte count decreased  1  10/23 (43.48%)  16 27/93 (29.03%)  63
Neutrophil count decreased  1  19/23 (82.61%)  85 66/93 (70.97%)  159
Platelet count decreased  1  22/23 (95.65%)  117 84/93 (90.32%)  307
Serum cholesterol increased  1  1/23 (4.35%)  1 3/93 (3.23%)  5
Weight loss  1  1/23 (4.35%)  1 2/93 (2.15%)  2
Metabolism and nutrition disorders     
Anorexia  1  2/23 (8.70%)  2 6/93 (6.45%)  8
Blood glucose increased  1  4/23 (17.39%)  9 7/93 (7.53%)  10
Dehydration  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Serum albumin decreased  1  0/23 (0.00%)  0 3/93 (3.23%)  4
Serum calcium decreased  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Serum calcium increased  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Serum phosphate decreased  1  3/23 (13.04%)  6 21/93 (22.58%)  40
Serum potassium decreased  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Serum potassium increased  1  1/23 (4.35%)  1 1/93 (1.08%)  1
Serum sodium decreased  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Serum triglycerides increased  1  6/23 (26.09%)  17 8/93 (8.60%)  20
Musculoskeletal and connective tissue disorders     
Bone pain  1  0/23 (0.00%)  0 2/93 (2.15%)  2
Joint pain  1  0/23 (0.00%)  0 2/93 (2.15%)  4
Muscle weakness  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Myalgia  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Pain in extremity  1  0/23 (0.00%)  0 1/93 (1.08%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Nervous system disorders     
Dizziness  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Headache  1  1/23 (4.35%)  5 1/93 (1.08%)  4
Ischemia cerebrovascular  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Memory impairment  1  1/23 (4.35%)  9 0/93 (0.00%)  0
Taste alteration  1  5/23 (21.74%)  12 4/93 (4.30%)  14
Tremor  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Psychiatric disorders     
Anxiety  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Confusion  1  1/23 (4.35%)  1 1/93 (1.08%)  1
Depression  1  0/23 (0.00%)  0 1/93 (1.08%)  4
Insomnia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Renal and urinary disorders     
Cystitis  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Urinary incontinence  1  1/23 (4.35%)  1 0/93 (0.00%)  0
Urinary retention  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Cough  1  1/23 (4.35%)  1 1/93 (1.08%)  1
Dyspnea  1  0/23 (0.00%)  0 4/93 (4.30%)  5
Hemorrhage nasal  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Hypoxia  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Pharyngolaryngeal pain  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pneumonitis  1  2/23 (8.70%)  3 4/93 (4.30%)  6
Respiratory tract hemorrhage  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Dry skin  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pain of skin  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Pruritus  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Rash acneiform  1  0/23 (0.00%)  0 1/93 (1.08%)  1
Rash desquamating  1  8/23 (34.78%)  26 28/93 (30.11%)  49
Vascular disorders     
Hypotension  1  0/23 (0.00%)  0 3/93 (3.23%)  3
Thrombosis  1  0/23 (0.00%)  0 2/93 (2.15%)  3
1
Term from vocabulary, MedDRA 6
Indicates events were collected by 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: Shaji Kumar, MD
Organization: Mayo Clinic Cancer Center
Phone: 507-284-2511
EMail: Kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00918333     History of Changes
Obsolete Identifiers: NCT01417559
Other Study ID Numbers: MC0886
NCI-2009-00934 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
08-004746
CLBH589BUS17T
MC0886 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2009
First Posted: June 11, 2009
Results First Submitted: April 19, 2018
Results First Posted: May 18, 2018
Last Update Posted: March 1, 2019