Aprepitant in Preventing Nausea and Vomiting in Patients... | NCT00248547 | Trialant
NCT00248547
Sponsor
OHSU Knight Cancer Institute
Status
Completed
Last Update Posted
May 9, 2017Actual
Enrollment
40Actual
Phase
Not Applicable
Conditions
Cancer
Interventions
aprepitant
dexamethasone
ondansetron
placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00248547
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000445452
Secondary IDs
ID
Type
Description
Link
OHSU-HEM-03074-L
Other Identifier
OHSU Knight Cancer Institute
OHSU-1057
Other Identifier
OHSU IRB
MERCK-OHSU-HEM-03074-L
Other Identifier
Merck
Brief Title
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
Official Title
A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)
Acronym
Not provided
Organization
OHSU Knight Cancer InstituteOTHER
Status Module
Record Verification Date
May 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2004
Primary Completion Date
Jan 2009Actual
Completion Date
Jan 2009Actual
First Submitted Date
Nov 3, 2005
First Submission Date that Met QC Criteria
Nov 3, 2005
First Posted Date
Nov 4, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 21, 2011
Results First Submitted that Met QC Criteria
Nov 21, 2011
Results First Posted Date
Dec 21, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 7, 2017
Last Update Posted Date
May 9, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Joseph Bubalo, PharmD, OHSU Knight Cancer InstitutePrincipal Investigator
Lead Sponsor
OHSU Knight Cancer InstituteOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.
PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.
Detailed Description
OBJECTIVES:
Primary
Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation.
Secondary
Determine the safety of aprepitant in these patients.
Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens.
Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients.
OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone.
Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I.
In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity.
After completion of study therapy, patients are followed until day 18.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
nausea and vomiting
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
40Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Aprepitant
Active Comparator
Drug: aprepitant
Drug: dexamethasone
Drug: ondansetron
sugar pill
Placebo Comparator
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Drug: dexamethasone
Drug: ondansetron
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
aprepitant
Drug
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Aprepitant
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Emesis Free Participants During the Study Period.
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Up to three weeks
Secondary Outcomes
Measure
Description
Time Frame
Safety in Transplant Population
To assess the safety of aprepitant in the bone marrow transplant population
Up to three weeks
Effects on Nausea, Appetite and Taste Changes
To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion:
18 years of age or greater
must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
Eastern Cooperative Oncology Group(ECOG) performance status < or = 2
patients must have signed informed consent
must be able to swallow tablets and capsules
must be receiving a cyclophosphamide containing regimen.
Exclusion:
patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
patient has received another investigational drug in the past 30 days
patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
patient has serum creatinine level > or = 2*ULN
patient has severe hepatic insufficiency (Child-Pugh score >9)
patient drinks > 5 drinks/day for the last year
patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Joseph Bubalo, PharmD
OHSU Knight Cancer Institute
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
OHSU Knight Cancer Institute
Portland
Oregon
97239-3098
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Inpatients receiving allogeneic bone marrow transplants who were to get either Busulfan/Cytoxan or Cytoxan/Total Body Radiation as conditioning regimen.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Aprepitant
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
FG001
Placebo
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00020 subjects
FG00120 subjects
COMPLETED
FG00020 subjects
FG00120 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Aprepitant
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
BG001
Placebo
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Emesis Free Participants During the Study Period.
To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period
Posted
Number
Participants
Up to three weeks
ID
Title
Description
OG000
Aprepitant
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
OG001
Placebo (Sugar Pill)
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Aprepitant
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Subileus
Gastrointestinal disorders
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Joseph Bubalo, PharmD
Oregon Health & Science University, Knight Cancer Institute
For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.
Aprepitant
sugar pill
Decadron
ondansetron
Drug
For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy
Aprepitant
sugar pill
Zofran
placebo
Drug
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
sugar pill
placebo, sugar pill
Up to three weeks
Pharmacokinetic Interaction
To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Up to three weeks
BG002
Total
Total of all reporting groups
20
BG00120
BG00240
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
BG00020
BG00120
BG00240
>=65 years
BG0000
BG0010
BG0020
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046± 12.9
BG00146± 13
BG00246± 13
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0016
BG00212
Male
BG00014
BG00114
BG00228
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00020
BG00120
BG00240
Units
Counts
Participants
OG00020
OG00120
Title
Denominators
Categories
Title
Measurements
OG00013
OG0015
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon Rank Sum Test
0.041
95
Superiority or Other
Secondary
Safety in Transplant Population
To assess the safety of aprepitant in the bone marrow transplant population
Not Posted
Up to three weeks
Participants
Secondary
Effects on Nausea, Appetite and Taste Changes
To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.
Not Posted
Up to three weeks
Participants
Secondary
Pharmacokinetic Interaction
To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.
Not Posted
Up to three weeks
Participants
2
20
0
20
EG001
Placebo
Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
0
20
0
20
EG000
2 affected
20 at risk
EG0010 affected20 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D006689
Hodgkin Disease
D016403
Lymphoma, Large B-Cell, Diffuse
D008228
Lymphoma, Non-Hodgkin
D016400
Lymphoma, Large-Cell, Immunoblastic
D016410
Lymphoma, T-Cell, Cutaneous
D008224
Lymphoma, Follicular
D020522
Lymphoma, Mantle-Cell
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D009447
Neuroblastoma
D000077216
Carcinoma, Ovarian Epithelial
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D013736
Testicular Neoplasms
D007943
Leukemia, Hairy Cell
D009101
Multiple Myeloma
D001943
Breast Neoplasms
D015464
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D007951
Leukemia, Myeloid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D001855
Bone Marrow Diseases
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D054437
Myelodysplastic-Myeloproliferative Diseases
D002471
Cell Transformation, Neoplastic
D063646
Carcinogenesis
D009385
Neoplastic Processes
D016393
Lymphoma, B-Cell
D008223
Lymphoma
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D007945
Leukemia, Lymphoid
D020031
Epstein-Barr Virus Infections
D006566
Herpesviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D014412
Tumor Virus Infections
D016399
Lymphoma, T-Cell
D018241
Neuroectodermal Tumors, Primitive, Peripheral
D018242
Neuroectodermal Tumors, Primitive
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
D002277
Carcinoma
D010051
Ovarian Neoplasms
D004701
Endocrine Gland Neoplasms
D009371
Neoplasms by Site
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications