Clinical trial NCT00042666: A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
Official title: A Phase 2 Evaluation of Oral LY317615 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-08-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: Randomization to measured progressive disease (PD) up to 34.3 months
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate)
timeFrame: Randomization to measured PD or death up to 34.3 months
measure: Progression Free Survival (PFS)
timeFrame: Randomization to PD or death due to any cause up to 34.3 months
measure: Duration of Overall Response (DOR)
timeFrame: Time of response to PD up to 34.3 months
measure: Number of Participants With Adverse Events (AEs) or Who Died
timeFrame: Randomization to study completion [Baseline up to 37 cycles (28-day cycles, 34.3 months) and 30-day follow-up]
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval (AUC0-24,ss) of Enzastaurin and Its Metabolite LY326020
timeFrame: 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)
measure: PKCβ Expression by IHC in Readily Assessable DLBCL Tumors From Participants
timeFrame: Baseline
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: 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.
state: Michigan
city: Minneapolis
country: United States
facility: 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.
state: Minnesota
city: Rochester
country: United States
facility: 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.
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: