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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
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Secondary ID [1]
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H6Q-MC-JCAO
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Secondary ID [2]
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8360
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mantle-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - enzastaurin
Experimental: A -
Treatment: Drugs: enzastaurin
500 milligrams (mg), oral, daily, up to six 28-day cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline through at least 3 cycles of treatment (28-day cycle)
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Secondary outcome [1]
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Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate)
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Assessment method [1]
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Timepoint [1]
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Baseline to 22.01 months
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to measured progressive disease or death due to any cause up to 22.01 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to date of death from any cause at least up to 23.10 months
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Secondary outcome [4]
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Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response]
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Assessment method [4]
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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.
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Timepoint [4]
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Date of progression or death due to any cause up to 22.01 months
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Secondary outcome [5]
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Time to New Treatment
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to date of new treatment up to 23.10 months
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Secondary outcome [6]
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Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Cycles 2, 4 and 6 (28-day cycle)
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Secondary outcome [7]
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Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Cycles 2, 4 and 6
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Secondary outcome [8]
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Number of Participants With Protein Kinase C Beta (PKCß) Expression by Immunohistochemistry (IHC) Staining
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Number of Participants With High Ki-67 Expression by IHC Staining
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Assessment method [9]
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IHC staining of tumor samples was carried out to determine Ki-67 expression. High expression is defined as the percentage of positive cells =40%.
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
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Assessment method [10]
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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.
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Timepoint [10]
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Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up
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Secondary outcome [11]
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Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)
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Assessment method [11]
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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.
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Timepoint [11]
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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
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Inability to swallow tablets
- Must not have significant heart problems
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2008
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment hospital [5]
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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
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Recruitment postcode(s) [1]
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- Woolloongabba
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Recruitment postcode(s) [2]
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- Parkville
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Recruitment postcode(s) [3]
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- Prahran
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Recruitment postcode(s) [4]
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- Wodonga
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Recruitment postcode(s) [5]
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- East Melbourne
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Creteil Cedex
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Country [2]
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France
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State/province [2]
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Lille
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Country [3]
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France
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State/province [3]
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Nantes Cedex 1
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Country [4]
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France
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State/province [4]
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Rouen Cedex
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Country [5]
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France
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State/province [5]
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Tours Cedex
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Country [6]
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Germany
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State/province [6]
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Berlin
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Country [7]
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Germany
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State/province [7]
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Homburg Saar
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Country [8]
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Germany
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State/province [8]
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Kassel
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Country [9]
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Germany
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State/province [9]
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Koln
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Country [10]
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Netherlands
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State/province [10]
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Groningen
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Country [11]
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Netherlands
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State/province [11]
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Nijmegen
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Country [12]
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Netherlands
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State/province [12]
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Rotterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00088205
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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.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00088205
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