NCT00042666

Brief Summary

This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2002

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

July 1, 2020

Enrollment Period

6.3 years

First QC Date

August 2, 2002

Results QC Date

June 9, 2020

Last Update Submit

July 20, 2020

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Relapsed or Refractory DLBCL Who Are Progression-Free for at Least 2 Cycles (28-Day Cycles) After Receiving Enzastaurin (LY317615) (Clinical Response Rate)

    Clinical Response Rate in participants with DLBCL was calculated as (number of participants who were progression-free for at least two 28-day cycles \[clinical responder\]) divided by (total number of participants analyzed) multiplied by 100. Progression free survival (PFS) defined as the time from randomization to the first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Randomization to measured progressive disease (PD) up to 34.3 months

Secondary Outcomes (6)

  • Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate)

    Randomization to measured PD or death up to 34.3 months

  • Progression Free Survival (PFS)

    Randomization to PD or death due to any cause up to 34.3 months

  • Duration of Overall Response (DOR)

    Time of response to PD up to 34.3 months

  • Number of Participants With Adverse Events (AEs) or Who Died

    Randomization to study completion [Baseline up to 37 cycles (28-day cycles, 34.3 months) and 30-day follow-up]

  • Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020

    Cycle 1 Day 1 predose, 1 to 4 hours postdose and Cycle 1 Day 28 predose and at least 1-hour postdose (28-day cycle)

  • +1 more secondary outcomes

Study Arms (1)

LY317615

EXPERIMENTAL

500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles

Drug: LY317615

Interventions

LY317615DRUG

500 mg, oral, QD, up to six 28 day cycles

Also known as: enzastaurin
LY317615

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of recurrent or refractory DLBCL.
  • Adequate organ functions.
  • Able to swallow capsules.

You may not qualify if:

  • More than 3 prior treatments for this disease.
  • Serious heart problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Royal Oak, Michigan, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Minneapolis, Minnesota, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rochester, Minnesota, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2002

First Posted

August 6, 2002

Study Start

June 1, 2002

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 10, 2020

Results First Posted

August 10, 2020

Record last verified: 2020-07

Locations

US(3)