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Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens (FOND-O)

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ClinicalTrials.gov Identifier: NCT02635984
Recruitment Status : Completed
First Posted : December 21, 2015
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
University of Georgia
Information provided by (Responsible Party):
Amber Clemmons, Augusta University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Complications of Bone Marrow Transplant
Hematologic Neoplasms
Interventions Drug: Olanzapine
Drug: Placebo
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Period Title: Overall Study
Started 53 55
Completed 50 51
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             2             4
Study Arm Closed             1             0
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine Total
Hide Arm/Group Description

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Total of all reporting groups
Overall Number of Baseline Participants 50 51 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 101 participants
56
(22 to 74)
54
(22 to 72)
55
(22 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Female
31
  62.0%
29
  56.9%
60
  59.4%
Male
19
  38.0%
22
  43.1%
41
  40.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  38.0%
21
  41.2%
40
  39.6%
White
29
  58.0%
27
  52.9%
56
  55.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.0%
3
   5.9%
5
   5.0%
Treatment Regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Chemotherapy Alone
16
  32.0%
17
  33.3%
33
  32.7%
HCT Conditioning
34
  68.0%
34
  66.7%
68
  67.3%
1.Primary Outcome
Title Overall Percentage of Patients Who Had a Complete Response
Hide Description Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
13
  26.0%
28
  54.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Patients With no Significant Nausea in Overall Assessment Period
Hide Description Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
14
  28.0%
30
  58.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Patients Achieving Complete Protection in Overall Assessment Phase
Hide Description (CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
13
  25.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Participants With no Significant Nausea in Acute Phase
Hide Description Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
33
  66.0%
39
  76.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Participants With no Significant Nausea in Delayed Phase
Hide Description Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
16
  32.0%
34
  66.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Percent of Patients With no Nausea in Overall Assessment Period
Hide Description No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
18
  35.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Percent of Patients With Complete Response in Acute Phase
Hide Description Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
31
  62.0%
39
  76.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Percent of Patients With Complete Response in Delayed Phase
Hide Description Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)
Time Frame Until study completion; estimated 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description:

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Overall Number of Participants Analyzed 50 51
Measure Type: Count of Participants
Unit of Measure: Participants
15
  30.0%
31
  60.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triplet Therapy Plus Placebo, Triplet Therapy Plus Olanzapine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed during this study. Adverse events were reported only via quantification of number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion). The time frame in which withdrawal from study was monitored for each patient was the duration of active study period (chemotherapy plus five days after).
Adverse Event Reporting Description

All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed.

Adverse events were monitored only by quantifying number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion).

 
Arm/Group Title Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Hide Arm/Group Description

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.

Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy

All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.

Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

All-Cause Mortality
Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Triplet Therapy Plus Placebo Triplet Therapy Plus Olanzapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      0/51 (0.00%)    
General disorders     
Withdrawal From Study  [1]  3/50 (6.00%)  3 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Patient or physician request to withdrawal from study
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: Dr. Amber Clemmons, Clinical Pharmacist - BMT/Hematology & Clinical Associate Professor
Organization: AU Medical Center / University of Georgia College of Pharmacy
Phone: 706-721-6493
EMail: aclemmons@augusta.edu
Layout table for additonal information
Responsible Party: Amber Clemmons, Augusta University
ClinicalTrials.gov Identifier: NCT02635984     History of Changes
Other Study ID Numbers: 818888
First Submitted: December 15, 2015
First Posted: December 21, 2015
Results First Submitted: June 22, 2018
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018