Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00088205
Registration number
NCT00088205
Ethics application status
Date submitted
22/07/2004
Date registered
23/07/2004
Date last updated
1/07/2020
Titles & IDs
Public title
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma
Query!
Scientific title
A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
Query!
Secondary ID [1]
0
0
H6Q-MC-JCAO
Query!
Secondary ID [2]
0
0
8360
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Mantle-Cell Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - enzastaurin
Experimental: A -
Treatment: Drugs: enzastaurin
500 milligrams (mg), oral, daily, up to six 28-day cycles
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
Query!
Assessment method [1]
0
0
Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100.
Query!
Timepoint [1]
0
0
Baseline through at least 3 cycles of treatment (28-day cycle)
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline to 22.01 months
Query!
Secondary outcome [2]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [2]
0
0
PFS time was defined as the time from the date of enrollment to the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. Progression-free survival time was censored at the date of the last assessment visit for participants who were still alive and who had not had documented progressive disease.
Query!
Timepoint [2]
0
0
Baseline to measured progressive disease or death due to any cause up to 22.01 months
Query!
Secondary outcome [3]
0
0
Overall Survival (OS)
Query!
Assessment method [3]
0
0
OS was defined as the time from the date of enrollment to the date of death due to any cause. For each participant who was not known to have died as of the data-inclusion cut-off date, OS was censored for that analysis at the date of the last assessment visit prior to the cut-off date.
Query!
Timepoint [3]
0
0
Baseline to date of death from any cause at least up to 23.10 months
Query!
Secondary outcome [4]
0
0
Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response]
Query!
Assessment method [4]
0
0
Duration of overall response for responders was measured from the date that measurement criteria were met for CR, CRu, PR or SD (whichever status occurred first) until the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas Guidelines, CR was defined as the disappearance of all lesions. CRu was the disappearance of clinical and radiographic evidence of disease, normal appearance of spleen and greater than 75% regression in lymph node mass. PR was defined as at least a 50% decrease in the six largest dominant nodes. SD was when the response was poorer than partial response with no new lesions consistent with progressive disease. Duration of response was censored at the date of the last assessment visit for responders who were still alive and had not had documented progressive disease.
Query!
Timepoint [4]
0
0
Date of progression or death due to any cause up to 22.01 months
Query!
Secondary outcome [5]
0
0
Time to New Treatment
Query!
Assessment method [5]
0
0
Time to new treatment was as the time from enrollment to the date new treatment for the cancer under study was initiated. Time to new treatment was censored at the date of the last assessment visit for participants who were not documented to have initiated a new treatment.
Query!
Timepoint [5]
0
0
Baseline to date of new treatment up to 23.10 months
Query!
Secondary outcome [6]
0
0
Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
Query!
Assessment method [6]
0
0
The B symptoms, tumor-related symptoms, participant functioning, and health-related quality of life were assessed with FACT-Lym v. 4. FACT-Lym v. 4 consists of 42 items with 5-point rating scales for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The lymphoma tumor - specific subscale consists of 15 items with a score ranging from 0-60. Fact-Lymphoma total score ranges from 0-168. A higher score represents better quality of life.
Query!
Timepoint [6]
0
0
Baseline, Cycles 2, 4 and 6 (28-day cycle)
Query!
Secondary outcome [7]
0
0
Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Query!
Assessment method [7]
0
0
Overall health status and participant utility values were measured with the EuroQol-5D questionnaire. EuroQol-5D describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 levels: 1 (no problem), 2 (some problem), and 3 (extreme problem). The questionnaire records the level of problems on each of 5 dimensions and is converted into the EuroQol-5D index based on preference weights (Dolan 1997), where a score of 0.0 = death and 1.0 = perfect health.
Query!
Timepoint [7]
0
0
Baseline, Cycles 2, 4 and 6
Query!
Secondary outcome [8]
0
0
Number of Participants With Protein Kinase C Beta (PKCß) Expression by Immunohistochemistry (IHC) Staining
Query!
Assessment method [8]
0
0
IHC staining of tumor samples was carried out to determine PKCß expression. Staining intensity was measured on a semiquantitative scale of 0 (or negative) to 3 (high intensity). The final score combined the components of staining intensity and the percentage of positive cells and was defined as \[1 \* (percentage of cells staining at 1)\] + \[2 \* (percentage of cells staining at 2)\] + \[3 \* (percentage of cells staining at 3)\]. Score =100 and staining intensity =2 indicates high expression for PKCß, while score \<100 and staining intensity =1 indicates low expression for PKCß.
Query!
Timepoint [8]
0
0
Baseline
Query!
Secondary outcome [9]
0
0
Number of Participants With High Ki-67 Expression by IHC Staining
Query!
Assessment method [9]
0
0
IHC staining of tumor samples was carried out to determine Ki-67 expression. High expression is defined as the percentage of positive cells =40%.
Query!
Timepoint [9]
0
0
Baseline
Query!
Secondary outcome [10]
0
0
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Query!
Assessment method [10]
0
0
Data presented are the number of participants who experienced SAEs, AEs, deaths due to progressive disease (PD), and deaths due to AEs while on treatment and death during the 30-day post-treatment follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Query!
Timepoint [10]
0
0
Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up
Query!
Secondary outcome [11]
0
0
Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)
Query!
Assessment method [11]
0
0
The Steady-state plasma concentrations of total analytes (enzastaurin plus its active metabolite, LSN326020) observed after once-daily dosing were evaluated using sparse sampling methodology.
Query!
Timepoint [11]
0
0
Cycles 1 [1-4 hours (h) and 4-8 h postdose], 2 (predose, 2-4 h and 6-8 h postdose), and 3 (predose and 2-8 h postdose) of Day 1 of each 28-day cycle
Query!
Eligibility
Key inclusion criteria
* Mantle cell lymphoma
* Previous treatment for mantle cell lymphoma
* Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens.
* Have discontinued all previous therapies for cancer, except corticosteroids up to 25 milligrams per day (mg/day)
* Adequate organ function
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Inability to swallow tablets
* Must not have significant heart problems
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - Woolloongabba
Query!
Recruitment hospital [2]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - Parkville
Query!
Recruitment hospital [3]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - Prahran
Query!
Recruitment hospital [4]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - Wodonga
Query!
Recruitment hospital [5]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [2]
0
0
- Parkville
Query!
Recruitment postcode(s) [3]
0
0
- Prahran
Query!
Recruitment postcode(s) [4]
0
0
- Wodonga
Query!
Recruitment postcode(s) [5]
0
0
- East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
France
Query!
State/province [1]
0
0
Creteil Cedex
Query!
Country [2]
0
0
France
Query!
State/province [2]
0
0
Lille
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Nantes Cedex 1
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Rouen Cedex
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
Tours Cedex
Query!
Country [6]
0
0
Germany
Query!
State/province [6]
0
0
Berlin
Query!
Country [7]
0
0
Germany
Query!
State/province [7]
0
0
Homburg Saar
Query!
Country [8]
0
0
Germany
Query!
State/province [8]
0
0
Kassel
Query!
Country [9]
0
0
Germany
Query!
State/province [9]
0
0
Koln
Query!
Country [10]
0
0
Netherlands
Query!
State/province [10]
0
0
Groningen
Query!
Country [11]
0
0
Netherlands
Query!
State/province [11]
0
0
Nijmegen
Query!
Country [12]
0
0
Netherlands
Query!
State/province [12]
0
0
Rotterdam
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00088205
Query!
Trial related presentations / publications
Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00088205
Download to PDF