Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Details
Study Description
Brief Summary
Primary Objective:
- To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.
Secondary Objectives:
-
To assess the complete and overall response rates for all Phase I and Phase II patients and to determine overall survival and event free survival for all Phase I and Phase II patients.
-
To assay the levels of kinase activity in NHL specimens and correlate this activity to patient outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Primary:
- To determine the Maximum Tolerated Dose (MTD) of Dasatinib in relapsed or refractory Non-Hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL
Secondary Objective:
-
To assess the complete and overall response rates for all Phase I and Phase II patients and to assay the levels of kinase activity in NHL specimens and correlate this activity to patient outcomes.
-
To determine overall survival and event free survival for all Phase I and Phase II patients.
Treatment Plan
This study has two phases of treatment, Phase I and Phase II. The Phase I portion of the trial will consist of a dose escalation plan with 3-6 patients being enrolled into each dose cohort. The doses of Dasatinib used in Phase I are 100 mg, 150 mg, and 200 mg. The dose that is found to be tolerated the best and also has the best treatment results will be used for Phase II. An additional 29 patients will be enrolled into Phase II.
All patients will receive Dasatinib in this study. Dasatinib will be administered orally (by mouth) once daily for 28 day cycles. A cycle will be considered 28 days. Dosing will be continuous with no interruptions, unless instructed to interrupt treatment by the treating physician.
The patient will be restaged after every 2 cycles of therapy, every even cycle. Therapy may continue as long as there are no clinical signs of NHL progressing and the patient is tolerating the treatment with no side effects related to the therapy. If the patient is removed from study for any reason, he/she will be followed for survival until death.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dasatinib Dose Escalation Phase 1 employed a standard 3+3 dose-escalation design to assess safety, MTD and dose-limiting toxicity (DLT). Maximum Tolerated Dose (MTD) was defined as the next lowest dose level below where ≥ 2/3 or ≥ 3/6 patients experience dose limiting toxicities in cycle 1. |
Drug: Dasatinib
Dasatinib will be orally administered once daily for 28 day cycles.
There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts:
Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day
The MTD will be determined in the Phase I portion of this trial.
Other Names:
|
| Experimental: Dasatinib Maximum Tolerated Dose Once the maximum tolerated dose is determined, an additional patients will be enrolled into the Phase II portion of this trial. |
Drug: Dasatinib Maximum Tolerated Dose
An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose [after 1-28 day cycle of therapy]
Secondary Outcome Measures
- Number of Participants With Clinical Response Rates [after 2-28 day cycles of therapy]
The Objective response rate (CR+PR) and the Clinical Benefit Rate (CR+PR+SD) were calculated according to revised response criteria for malignant lymphoma (Cheson) CR - Complete response is defined as: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. PR - Partial response is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. SD - Stable Disease is define as: Failing to attain the criteria needed for a PR, but not fulfilling those for progressive disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed diagnosis of non-hodgkin's lymphoma that is recurrent or refractory after at least one prior therapy and for which no other potentially curative therapy is available.
-
Subject, age > or = 19 years
-
Performance status (ECOG) 0-2
-
Patients must have relapsed or refractory disease after at least one prior systemic therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen. Recover to ≤ grade 1 from all toxicities related to the prior treatments is required.
-
Patients must be ineligible or relapsed after an autologous or allogeneic stem cell transplant if clinically appropriate.
-
Adequate Laboratory Parameters:
-
ANC ≥ 1000/μL
-
Platelet count ≥ 50,000/μL
-
Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
-
Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
-
Serum creatinine < 2.0 times the institutional ULN
-
PTT within institutional normal limits
-
Ability to take oral medication (dasatinib must be swallowed whole)
-
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (sensitivity < or = 25IU HCG/L) within 72 hours prior to the start of study drug administration
-
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 6 months after study drug is stopped
-
Signed written informed consent including HIPAA according to institutional guidelines
Exclusion Criteria:
-
No malignancy [other than the one treated in this study] which required systemic treatment within the past 3 years.
-
Concurrent medical condition which may increase the risk of toxicity, including:
-
Clinically significant pleural or pericardial effusion
-
Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
-
Cardiac Symptoms, consider the following:
-
Uncontrolled angina, congestive heart failure or MI within (6 months)
-
Diagnosed congenital long QT syndrome
-
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
-
Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
-
Subjects with hypokalemia or hypomagnesemia if it cannot be corrected
-
History of significant bleeding disorder unrelated to cancer, including:
-
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
-
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
-
Ongoing or recent (< or = 3 months) significant gastrointestinal bleeding
-
Concomitant Medications, consider the following prohibitions:
-
Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib.) quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide,erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
-
The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.
-
Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
-
Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
-
Patient may not be receiving any prohibited CYP3A4 inhibitors
-
Women:
-
Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks 6 months after cessation of study drug
-
Have a positive pregnancy test at baseline
-
Are pregnant or breastfeeding
-
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska Medical Center - Internal Medicine Section of Oncology/Hematology | Omaha | Nebraska | United States | 68198-7680 |
Sponsors and Collaborators
- University of Nebraska
- Bristol-Myers Squibb
Investigators
- Principal Investigator: Julie Vose, M.D., University of Nebraska
Study Documents (Full-Text)
None provided.More Information
Publications
- Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95.
- Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.
- Hochhaus, A. et al. Dasatinib (SPRYCEL) 50mg or 70mg BID Versus 100mg or 140mg QD in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Resistant or Intolerant to Imatinib: Results of the CA180-034 Study. American Society of Hematology, 2006 Meeting Abstracts, Part 1, Volume 108, Issue 11, November 16, 2006.
- Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.
- Mahadevan D, Spier C, Della Croce K, Miller S, George B, Riley C, Warner S, Grogan TM, Miller TP. Transcript profiling in peripheral T-cell lymphoma, not otherwise specified, and diffuse large B-cell lymphoma identifies distinct tumor profile signatures. Mol Cancer Ther. 2005 Dec;4(12):1867-79.
- Sprangers M, Feldhahn N, Herzog S, Hansmann ML, Reppel M, Hescheler J, Jumaa H, Siebert R, Müschen M. The SRC family kinase LYN redirects B cell receptor signaling in human SLP65-deficient B cell lymphoma cells. Oncogene. 2006 Aug 17;25(36):5056-62. Epub 2006 Mar 27.
- SPRYCEL (dasatinib) Tablets Prescribing Information. Bristol-Myers Squibb Company, Princeton, NJ. June 2006
- SPRYCEL® (dasatinib) BMS-354825 Bristol-Myers Squibb Investigator Brochure, Version #5, 2006.
- SPRYCEL® (dasatinib) BMS-354825 Bristol-Myers Squibb Investigator Brochure, Version #6 in print, 2006.
- Thompson MA, Stumph J, Henrickson SE, Rosenwald A, Wang Q, Olson S, Brandt SJ, Roberts J, Zhang X, Shyr Y, Kinney MC. Differential gene expression in anaplastic lymphoma kinase-positive and anaplastic lymphoma kinase-negative anaplastic large cell lymphomas. Hum Pathol. 2005 May;36(5):494-504.
- Zhu DM, Tibbles HE, Vassilev AO, Uckun FM. SYK and LYN mediate B-cell receptor-independent calcium-induced apoptosis in DT-40 lymphoma B-cells. Leuk Lymphoma. 2002 Nov;43(11):2165-70.
- 244-07-FB
- BMS Protocol 180129
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Phase I Dose Cohort # 1 (100 mg Per Day) | Phase I Dose Cohort # 2 (150 mg Per Day) | Phase I Dose Cohort # 3 (200 mg Per Day) | Phase II Participants |
|---|---|---|---|---|
| Arm/Group Description | Dasatinib will be orally administered once daily for 28 day cycles. | Dasatinib will be orally administered once daily for 28 day cycles. | Dasatinib will be orally administered once daily for 28 day cycles. | Dasatinib: No DLT was encountered and hence the MTD was determined to be 200 mg PO daily. This was subsequently reduced to 150 mg PO daily when a higher incidence of grade 3 pleural effusions was noted. |
| Period Title: Overall Study | ||||
| STARTED | 3 | 3 | 10 | 22 |
| COMPLETED | 3 | 3 | 6 | 12 |
| NOT COMPLETED | 0 | 0 | 4 | 10 |
Baseline Characteristics
| Arm/Group Title | Phase I Participants | Phase II Participants | Total |
|---|---|---|---|
| Arm/Group Description | Dasatinib will be orally administered once daily for 28 day cycles. There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts: Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day | Dasatinib: The MTD will be determined in the Phase I portion of this trial. An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I. | Total of all reporting groups |
| Overall Participants | 16 | 22 | 38 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
59
|
61
|
59
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
43.8%
|
8
36.4%
|
15
39.5%
|
| Male |
9
56.3%
|
14
63.6%
|
23
60.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
16
100%
|
19
86.4%
|
35
92.1%
|
| Black, Not Hispanic |
0
0%
|
1
4.5%
|
1
2.6%
|
| Hispanic |
0
0%
|
1
4.5%
|
1
2.6%
|
| Other |
0
0%
|
1
4.5%
|
1
2.6%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
16
100%
|
22
100%
|
38
100%
|
Outcome Measures
| Title | Maximum Tolerated Dose |
|---|---|
| Description | |
| Time Frame | after 1-28 day cycle of therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two subjects enrolled in Phase 1 of the study were never treated and not included in the analysis. |
| Arm/Group Title | All Phase I Participants |
|---|---|
| Arm/Group Description | All participants who enrolled and treated with a minimum of 1 cycle of Dasatinib. |
| Measure Participants | 14 |
| Number [milligrams PO daily] |
200
|
| Title | Number of Participants With Clinical Response Rates |
|---|---|
| Description | The Objective response rate (CR+PR) and the Clinical Benefit Rate (CR+PR+SD) were calculated according to revised response criteria for malignant lymphoma (Cheson) CR - Complete response is defined as: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. PR - Partial response is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. SD - Stable Disease is define as: Failing to attain the criteria needed for a PR, but not fulfilling those for progressive disease. |
| Time Frame | after 2-28 day cycles of therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 38 participants consented only 24 for were evaluable. See the participant flow section. |
| Arm/Group Title | Evauable Participants From Both Phases of the Trial |
|---|---|
| Arm/Group Description | Response assessment was analyzed for both phases of the trial combined. |
| Measure Participants | 24 |
| Objective response rate |
7
43.8%
|
| Clinical Benefit Rate |
17
106.3%
|
Adverse Events
| Time Frame | Adverse Events were collected from the time of enrollment until 30 days after the participant completed study treatment. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All doses for Phase I participants are combined as occasionally, subjects experienced adverse events leading to dose reductions so may not complete treatment at starting dose. Additionally, final adverse event reporting is most important at the maximum tolerated dose determined and use in Phase II of study. | |||
| Arm/Group Title | Phase I Participants | Phase II Participants | ||
| Arm/Group Description | All participants that were dose were monitored for adverse events. | All participants that were dose were monitored for adverse events. | ||
All Cause Mortality |
||||
| Phase I Participants | Phase II Participants | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/14 (7.1%) | 4/19 (21.1%) | ||
Serious Adverse Events |
||||
| Phase I Participants | Phase II Participants | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/14 (50%) | 9/19 (47.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Endocrine disorders | ||||
| Adrenal insufficiency | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Eye disorders | ||||
| cataracts | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| General disorders | ||||
| Fever | 2/14 (14.3%) | 2 | 3/19 (15.8%) | 4 |
| flu like symptoms | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Infections and infestations | ||||
| Other, Infection not specify | 3/14 (21.4%) | 3 | 1/19 (5.3%) | 1 |
| Appendicitis | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Enterocolitis infectious | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Investigations | ||||
| platelet count decreased | 0/14 (0%) | 0 | 1/19 (5.3%) | 2 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| dehydration | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other, failure to thrive | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| hyponatremia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Avascular necrosis | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other, cellulitis | 2/14 (14.3%) | 2 | 1/19 (5.3%) | 1 |
| Renal and urinary disorders | ||||
| Other, acute renal insufficiency | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 2/14 (14.3%) | 3 | 2/19 (10.5%) | 3 |
| dyspnea | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| pneumonia | 2/14 (14.3%) | 2 | 0/19 (0%) | 0 |
| pulmonary edema | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| hypoxia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Surgical and medical procedures | ||||
| Other, appendectomy | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Phase I Participants | Phase II Participants | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/14 (100%) | 18/19 (94.7%) | ||
| Blood and lymphatic system disorders | ||||
| anemia | 9/14 (64.3%) | 10 | 7/19 (36.8%) | 13 |
| anemia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Cardiac disorders | ||||
| pericardial effusion | 2/14 (14.3%) | 2 | 2/19 (10.5%) | 3 |
| palpitation | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| heart failure | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - tachycardia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| vertigo | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Endocrine disorders | ||||
| Other - thyroid nodule | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Eye disorders | ||||
| cataract | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| dry eyes | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - eye swelling | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - visual disturbances | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Gastrointestinal disorders | ||||
| diarrhea | 3/14 (21.4%) | 4 | 9/19 (47.4%) | 9 |
| Nausea | 5/14 (35.7%) | 6 | 7/19 (36.8%) | 7 |
| vomiting | 5/14 (35.7%) | 5 | 3/19 (15.8%) | 3 |
| Anorexia | 3/14 (21.4%) | 3 | 3/19 (15.8%) | 3 |
| abdominal pain | 1/14 (7.1%) | 1 | 3/19 (15.8%) | 3 |
| gastrointestinal pain | 2/14 (14.3%) | 2 | 0/19 (0%) | 0 |
| Other, bloated stomach | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| constipation | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Flatulence | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - hematochezia | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| hemorrhoidal hemorrhage | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other, intermittent diarrhea | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other, ulcer | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| hemorrhoids | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| General disorders | ||||
| Fatigue | 6/14 (42.9%) | 7 | 8/19 (42.1%) | 8 |
| fever | 2/14 (14.3%) | 2 | 5/19 (26.3%) | 5 |
| weakness | 0/14 (0%) | 0 | 4/19 (21.1%) | 4 |
| chills | 1/14 (7.1%) | 1 | 2/19 (10.5%) | 2 |
| Other - edema | 2/14 (14.3%) | 2 | 3/19 (15.8%) | 4 |
| Other - cold feeling sensation | 0/14 (0%) | 0 | 2/19 (10.5%) | 2 |
| Pain | 1/14 (7.1%) | 1 | 1/19 (5.3%) | 1 |
| edema limbs | 2/14 (14.3%) | 2 | 0/19 (0%) | 0 |
| Non-cardiac chest pain | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other, generalized aches | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - disease pain | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| edema limbs | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - swollen feet | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Immune system disorders | ||||
| allergic reaction | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - alveolar inflitrates | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Infections and infestations | ||||
| Other - rash | 4/14 (28.6%) | 7 | 2/19 (10.5%) | 2 |
| skin infection | 2/14 (14.3%) | 5 | 0/19 (0%) | 0 |
| Infection | 2/14 (14.3%) | 11 | 0/19 (0%) | 0 |
| Lung infection | 2/14 (14.3%) | 3 | 0/19 (0%) | 0 |
| sinusitis | 1/14 (7.1%) | 2 | 1/19 (5.3%) | 1 |
| enterocolitis infection | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| mucosal infection | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Upper respiratory infection | 1/14 (7.1%) | 1 | 1/19 (5.3%) | 1 |
| Urinary tract infection | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - gastroenteritis | 1/14 (7.1%) | 3 | 0/19 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Other, failed skin graft | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Investigations | ||||
| platelet count decreased | 6/14 (42.9%) | 6 | 11/19 (57.9%) | 17 |
| White blood cell decreased | 4/14 (28.6%) | 4 | 5/19 (26.3%) | 12 |
| Neutrophil count decreased | 2/14 (14.3%) | 4 | 6/19 (31.6%) | 12 |
| creatinine increased | 2/14 (14.3%) | 8 | 0/19 (0%) | 0 |
| Electrocardiogram QT corrected interval prolonged | 1/14 (7.1%) | 1 | 1/19 (5.3%) | 1 |
| Alkaline phosphatase increased | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| aspartate aminotransferase increased | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| lymphocyte count increased | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - loose stools | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| weight loss | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| hypokalemia | 3/14 (21.4%) | 3 | 0/19 (0%) | 0 |
| dehydration | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Hypoglycemia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Hypomagnesemia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| myalgia | 1/14 (7.1%) | 1 | 1/19 (5.3%) | 1 |
| back pain | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| bone pain | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other, gout | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Arthralgia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - leg pain | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - Muscle cramping | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - muscle pain | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - muscle spasm | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other, myopathy | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - pain in feet | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - foot pain | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Nervous system disorders | ||||
| headache | 4/14 (28.6%) | 4 | 2/19 (10.5%) | 2 |
| Other - neuropathy | 1/14 (7.1%) | 1 | 2/19 (10.5%) | 2 |
| dysgeusia | 0/14 (0%) | 0 | 2/19 (10.5%) | 2 |
| dizziness | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| lethargy | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Psychiatric disorders | ||||
| insomnia | 2/14 (14.3%) | 3 | 0/19 (0%) | 0 |
| anxiety | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - panic attacks | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Renal and urinary disorders | ||||
| Other, dysuria | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Urinary incontinence | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Urinary urgency | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| gynecomastia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| genital edima | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| genital edema | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Other - vaginal atrophy | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 11/14 (78.6%) | 15 | 6/19 (31.6%) | 7 |
| dyspnea | 2/14 (14.3%) | 3 | 1/19 (5.3%) | 1 |
| cough | 0/14 (0%) | 0 | 2/19 (10.5%) | 2 |
| Other, decrease oxygenation | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| cough | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - Hypoxemia | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - pulmonary infiltrates | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| pruritus | 1/14 (7.1%) | 1 | 1/19 (5.3%) | 1 |
| Other - granuloma annulare | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other - Hives | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| Other, inflammatory skin | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| periorbital edema | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| skin ulceration | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
| skin ulcer | 0/14 (0%) | 0 | 1/19 (5.3%) | 1 |
| Vascular disorders | ||||
| flushing | 1/14 (7.1%) | 1 | 0/19 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Julie M Vose, MD |
|---|---|
| Organization | University of Nebraska |
| Phone | 402-559-348 |
| jmvose@unmc.edu |
- 244-07-FB
- BMS Protocol 180129