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CompletedNCT00110357Updated Dec 24, 2015Results posted

Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

A Phase 1 interventional study of Cetuximab + Irinotecan and Cetuximab + Irinotecan in Cancer and Refractory Solid Tumor, sponsored by Eli Lilly and Company. Completed at 9 sites in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2015-12-24.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.

02

Conditions studied

  • Cancer
  • Refractory Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of a solid tumor which has progressed on, or following standard therapy, or for which no standard effective therapy is known.
  • Children age 1-18 years.

Exclusion criteria

Exclusion Criteria:

  • Presence of active infection.
  • Requirement to receive concurrent chemotherapy immunotherapy, radiotherapy, or any other investigational drug while on study.
  • Inadequate bone marrow, hepatic, or renal function.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Group A

    1-12 years old

    Drug: Cetuximab + Irinotecan

  • Active comparator
    Group B

    13-18 years old

    Drug: Cetuximab + Irinotecan

Interventions

  • DrugCetuximab + Irinotecan

    Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.

  • DrugCetuximab + Irinotecan

    Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan

    MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)

    Time frame: Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.

Secondary outcomes

  1. Number of Participants With a Dose-Limiting Toxicity

    Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).

    Time frame: Prior to each 21-day cycle until dose-limiting toxicities

  2. Maximum Plasma Concentration (Cmax)

    The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

  3. Area Under the Curve, Extrapolated to Infinity (AUC[INF])

    The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

  4. Terminal Half-Life (T-Half)

    The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

  5. Clearance Corrected for Body Surface Area (CL/BSA)

    The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

  6. Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)

    The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

  7. Tumor Response

    Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression"). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam.

    Time frame: Every other 21-day cycle

  8. Human Anti-cetuximab Antibody (HACA) Response

    In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value \> 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.

    Time frame: Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle

  9. Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)

    Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.

    Time frame: Weekly throughout the study and every 4 weeks thereafter

  10. Grade 3-4 Laboratory Abnormalities - Leukopenia

    Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

  11. Grade 3-4 Laboratory Abnormalities - Neutropenia

    Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

  12. Grade 3-4 Laboratory Abnormalities - Thrombocytopenia

    Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

  13. Grade 3/4 Laboratory Abnormalities - Hypomagnesemia

    Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

07

Results

Posted Aug 11, 2009

Participant flow

Participant flow — Overall Study
Milestone1- to 12-years-old13- to 18-years-old
Started2719
Completed00
Not completed2719
Withdrew: Deterioration without progression20
Withdrew: Disease progression/relapse2015
Withdrew: Study closure10
Withdrew: Study drug toxicity13
Withdrew: Withdrawal by subject31

Outcome measures

SecondaryNumber of Participants With a Dose-Limiting Toxicity

Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).

Time frame:
Prior to each 21-day cycle until dose-limiting toxicities
Reported as:
Number · Participants
Number of Participants With a Dose-Limiting Toxicity
ParticipantsGroup A: 75/20Group A: 150/20Group A 150/16Group A: 250/16Group B: 75/20Group B: 150/20Group B: 250/20
Subjects with a dose-limiting toxicity1200101
Subjects with no dose-limiting toxicity54312746
SecondaryMaximum Plasma Concentration (Cmax)

The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.

Time frame:
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Reported as:
Geometric mean · µg/mL
Maximum Plasma Concentration (Cmax)
µg/mLGroup A: 75Group A :150Group A: 250Group B: 75Group B: 150Group B: 250
Maximum Plasma Concentration (Cmax)50.5 ± 16.7112.9 ± 24.7163.7 ± 31.153.4 ± 21.783.1 ± 13.2148.5 ± 28.1
SecondaryArea Under the Curve, Extrapolated to Infinity (AUC[INF])

The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.

Time frame:
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Reported as:
Geometric mean · µg•h/mL
Area Under the Curve, Extrapolated to Infinity (AUC[INF])
µg•h/mLGroup A: 75Group A :150Group A: 250Group B: 75Group B: 150Group B: 250
Area Under the Curve, Extrapolated to Infinity (AUC[INF])1598.3 ± 863.328871.2 ± 1861.117706.0 ± 6384.51925.2 ± 460.67027.3 ± 239.513410.4 ± 5484.5
SecondaryTerminal Half-Life (T-Half)

The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.

Time frame:
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Reported as:
Mean · hours
Terminal Half-Life (T-Half)
hoursGroup A: 75Group A :150Group A: 250Group B: 75Group B: 150Group B: 250
Terminal Half-Life (T-Half)31.0 ± 13.975.2 ± 18.7110.3 ± 43.137.9 ± 6.361.1 ± 10.581.9 ± 20.4
SecondaryClearance Corrected for Body Surface Area (CL/BSA)

The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.

Time frame:
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Reported as:
Mean · L/h/m2
Clearance Corrected for Body Surface Area (CL/BSA)
L/h/m2Group A: 75Group A :150Group A: 250Group B: 75Group B: 150Group B: 250
Clearance Corrected for Body Surface Area (CL/BSA)0.057 ± 0.0410.017 ± 0.0040.015 ± 0.0050.040 ± 0.0100.021 ± 0.0010.020 ± 0.009
SecondaryVolume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)

The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.

Time frame:
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Reported as:
Mean · L/m2
Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)
L/m2Group A: 75Group A: 150Group A: 250Group B: 75Group B: 150Group B: 250
Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)2.081 ± 0.6661.860 ± 0.5642.157 ± 0.3622.138 ± 0.4531.887 ± 0.2622.179 ± 0.250
SecondaryTumor Response

Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression"). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam.

Time frame:
Every other 21-day cycle
Reported as:
Number · Participants
Tumor Response
ParticipantsCNS Primary TumorNon-CNS Primary Tumor
Partial Response20
Stable Disease108
Progressive Disease1011
Not Assessable/Unable to Determine41
SecondaryHuman Anti-cetuximab Antibody (HACA) Response

In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value \> 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.

Time frame:
Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle
Reported as:
Number · Participants
Human Anti-cetuximab Antibody (HACA) Response
ParticipantsNumber of Participants
Evaluable Participants27
Unevaluable Participants15
Participants with positive HACA level1
SecondaryNumber of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)

Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.

Time frame:
Weekly throughout the study and every 4 weeks thereafter
Reported as:
Number · Participants
Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)
ParticipantsGroup A: 75/20Group A: 150/20Group A 150/16Group A: 250/16Group B: 75/20Group B: 150/20Group B: 250/20
Deaths (total)0525311
Deaths within 30 days of last dose0203001
SAEs2406534
AEs leading to discontinuation of study treatment0100210
Grade 3-4 AEs4425744
PrimaryMaximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan

MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)

Time frame:
Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.
Reported as:
Number · mg/m2
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
mg/m2Group A (Ages 1-12 Years)Group B (Ages 13-18 Years)
MTD cetuximab (in combination w/ irinotecan)250250
MTD irinotecan (in combination w/ cetuximab)1620
RPIID cetuximab (in combination with irinotecan)250250
RPIID irinotecan (in combination with cetuximab)1620
SecondaryGrade 3-4 Laboratory Abnormalities - Leukopenia

Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

Time frame:
pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
Reported as:
Number · Participants
Grade 3-4 Laboratory Abnormalities - Leukopenia
ParticipantsGroup A 75/20Group A 150/16Group A 150/20Group A 250/16Group B 75/20Group B 150/20Group B 250/20
Grade 3-4 Laboratory Abnormalities - Leukopenia3034224
SecondaryGrade 3-4 Laboratory Abnormalities - Neutropenia

Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE

Time frame:
pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
Reported as:
Number · Participants
Grade 3-4 Laboratory Abnormalities - Neutropenia
ParticipantsGroup A 75/20Group A 150/16Group A 150/20Group A 250/16Group B 75/20Group B 150/20Group B 250/20
Grade 3-4 Laboratory Abnormalities - Neutropenia3033314
SecondaryGrade 3-4 Laboratory Abnormalities - Thrombocytopenia

Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

Time frame:
pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
Reported as:
Number · Participants
Grade 3-4 Laboratory Abnormalities - Thrombocytopenia
ParticipantsGroup A 75/20Group A 150/16Group A 150/20Group A 250/16Group B 75/20Group B 150/20Group B 250/20
Grade 3-4 Laboratory Abnormalities - Thrombocytopenia1032004
SecondaryGrade 3/4 Laboratory Abnormalities - Hypomagnesemia

Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE

Time frame:
pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
Reported as:
Number · Participants
Grade 3/4 Laboratory Abnormalities - Hypomagnesemia
ParticipantsGroup A 75/20Group A 150/16Group A 150/20Group A 250/16Group B 75/20Group B 150/20Group B 250/20
Grade 3/4 Laboratory Abnormalities - Hypomagnesemia———1———

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
01 75 mg/m2 CET + 20 mg/m2 IRI—7/14 (50%)14/14 (100%)
02 150 mg/m2 CET + 20 mg/m2 IRI—7/10 (70%)8/10 (80%)
03 150 mg/m2 CET + 16 mg/m2 IRI—0/3 (0%)3/3 (100%)
04 250 mg/m2 CET + 16 mg/m2 IRI—6/12 (50%)12/12 (100%)
05 250 mg/m2 CET + 20 mg/m2 IRI—4/7 (57.1%)7/7 (100%)
Most frequent serious events
Showing 10 of 66
Most frequent serious events
Event01 75 mg/m2 CET + 20 mg/m2 IRI02 150 mg/m2 CET + 20 mg/m2 IRI03 150 mg/m2 CET + 16 mg/m2 IRI04 250 mg/m2 CET + 16 mg/m2 IRI05 250 mg/m2 CET + 20 mg/m2 IRI
MALIGNANT NEOPLASM PROGRESSIONNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/140/100/30/123/7
PYREXIAGeneral disorders2/143/100/31/120/7
NAUSEAGastrointestinal disorders1/143/100/30/121/7
VOMITINGGastrointestinal disorders3/142/100/31/121/7
DIARRHOEAGastrointestinal disorders2/142/100/31/121/7
CHILLSGeneral disorders0/142/100/30/120/7
DEHYDRATIONMetabolism and nutrition disorders2/141/100/32/120/7
HYPOMAGNESAEMIAMetabolism and nutrition disorders0/140/100/30/121/7
NEUTROPHIL COUNTInvestigations0/140/100/30/121/7
CRANIAL NEUROPATHYNervous system disorders0/140/100/30/121/7
Most frequent other events
Showing 10 of 256
Most frequent other events
Event01 75 mg/m2 CET + 20 mg/m2 IRI02 150 mg/m2 CET + 20 mg/m2 IRI03 150 mg/m2 CET + 16 mg/m2 IRI04 250 mg/m2 CET + 16 mg/m2 IRI05 250 mg/m2 CET + 20 mg/m2 IRI
NAUSEAGastrointestinal disorders11/145/100/37/126/7
VOMITINGGastrointestinal disorders11/145/101/39/126/7
DIARRHOEAGastrointestinal disorders11/147/102/310/126/7
ABDOMINAL PAINGastrointestinal disorders7/145/101/39/122/7
RASHSkin and subcutaneous tissue disorders3/144/102/35/125/7
HEADACHENervous system disorders9/144/102/37/124/7
WEIGHT DECREASEDInvestigations4/144/101/38/122/7
DRY SKINSkin and subcutaneous tissue disorders3/142/100/37/124/7
ANOREXIAMetabolism and nutrition disorders6/143/100/36/122/7
CONSTIPATIONGastrointestinal disorders3/141/101/35/121/7

Baseline characteristics

Age, Continuous
Age, Continuous(years)1- to 12-years-old13- to 18-years-oldTotal
Median8.0 (1.0 to 12.0)16.0 (13.0 to 18.0)10 (1.0 to 18.0)
Sex: Female, Male
Sex: Female, Male(Participants)1- to 12-years-old13- to 18-years-oldTotal
Female15924
Male121022
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)1- to 12-years-old13- to 18-years-oldTotal
Asian022
Black or African American527
White211435
Other112
Disease diagnosis
Disease diagnosis(Participants)1- to 12-years-old13- to 18-years-oldTotal
CNS Primary Tumor17926
Non-CNS Primary Tumor101020
Performance Status
Performance Status(Participants)1- to 12-years-old13- to 18-years-oldTotal
>70-100191635
≥50-708311
<50000
08

Study locations

9 sites
  • Phoenix Children'S Hospital
    Phoenix, Arizona 85016, United States
  • University Of Arizona Health Sciences Center
    Tucson, Arizona 85724, United States
  • The Children'S Hospital
    Denver, Colorado 80218, United States
  • University Of Florida
    Gainesville, Florida 32610, United States
  • Children'S Healthcare Of Atlanta
    Atlanta, Georgia 30322, United States
  • Sidney Kimmel Cancer Center At Johns Hopkins
    Baltimore, Maryland 21231, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • Vanderbilt University Medical Center Infectious Diseases
    Nashville, Tennessee 37232, United States
  • University Of Texas Md Anderson Cancer Ctr
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Trippett TM, Herzog C, Whitlock JA, Wolff J, Kuttesch J, Bagatell R, Hunger SP, Boklan J, Smith AA, Arceci RJ, Katzenstein HM, Harbison C, Zhou X, Lu H, Langer C, Weber M, Gore L. Phase I and pharmacokinetic study of cetuximab and irinotecan in children with refractory solid tumors: a study of the pediatric oncology experimental therapeutic investigators' consortium. J Clin Oncol. 2009 Oct 20;27(30):5102-8. doi: 10.1200/JCO.2008.20.8975. Epub 2009 Sep 21. PubMed 19770383 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00110357
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 9, 2005
Start date
Aug 2005
Primary completion
Mar 2008
Completion
Mar 2008
Results posted
Aug 11, 2009
Last update
Dec 24, 2015

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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