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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
Scientific title
A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
Secondary ID [1] 0 0
H6Q-MC-JCAO
Secondary ID [2] 0 0
8360
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mantle-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - enzastaurin

Experimental: A -


Treatment: Drugs: enzastaurin
500 milligrams (mg), oral, daily, up to six 28-day cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles
Timepoint [1] 0 0
Baseline through at least 3 cycles of treatment (28-day cycle)
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate)
Timepoint [1] 0 0
Baseline to 22.01 months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Baseline to measured progressive disease or death due to any cause up to 22.01 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to date of death from any cause at least up to 23.10 months
Secondary outcome [4] 0 0
Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response]
Timepoint [4] 0 0
Date of progression or death due to any cause up to 22.01 months
Secondary outcome [5] 0 0
Time to New Treatment
Timepoint [5] 0 0
Baseline to date of new treatment up to 23.10 months
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)
Timepoint [6] 0 0
Baseline, Cycles 2, 4 and 6 (28-day cycle)
Secondary outcome [7] 0 0
Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status)
Timepoint [7] 0 0
Baseline, Cycles 2, 4 and 6
Secondary outcome [8] 0 0
Number of Participants With Protein Kinase C Beta (PKCß) Expression by Immunohistochemistry (IHC) Staining
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Number of Participants With High Ki-67 Expression by IHC Staining
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin)
Timepoint [10] 0 0
Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up
Secondary outcome [11] 0 0
Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes)
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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to swallow tablets
* Must not have significant heart problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD,VIC
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
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
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
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
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
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment postcode(s) [3] 0 0
- Prahran
Recruitment postcode(s) [4] 0 0
- Wodonga
Recruitment postcode(s) [5] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Creteil Cedex
Country [2] 0 0
France
State/province [2] 0 0
Lille
Country [3] 0 0
France
State/province [3] 0 0
Nantes Cedex 1
Country [4] 0 0
France
State/province [4] 0 0
Rouen Cedex
Country [5] 0 0
France
State/province [5] 0 0
Tours Cedex
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Homburg Saar
Country [8] 0 0
Germany
State/province [8] 0 0
Kassel
Country [9] 0 0
Germany
State/province [9] 0 0
Koln
Country [10] 0 0
Netherlands
State/province [10] 0 0
Groningen
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nijmegen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00088205
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.
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00088205