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CompletedNCT00415636Updated Oct 19, 2018Results posted

Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer

A Phase 1 interventional study of IC83/LY2603618 and IC83/LY2603618 in Cancer, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-19.

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

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

02

Conditions studied

  • Cancer
03

In context

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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

  • Has fully recovered from all toxicities due to the following:

    1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
    2. Surgery.
  • Has a life expectancy of at least 3 months.
  • Negative serum pregnancy test.

Exclusion criteria

Exclusion Criteria:

  • Is pregnant or breastfeeding.
  • Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
  • Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
  • Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
  • Has a known active infection.
05

Study design

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

Study arms

  • Experimental
    LY2603618 40 mg/m^2 (4.5-hour infusion)

    LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed.

    Drug: IC83/LY2603618 · Drug: pemetrexed

  • Experimental
    LY2603618 40 mg/m^2 (1-hour infusion)

    Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), the LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed.

    Drug: IC83/LY2603618 · Drug: pemetrexed

  • Experimental
    LY2603618 70 mg/m^2

    Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour.

    Drug: IC83/LY2603618 · Drug: pemetrexed

  • Experimental
    LY2603618 105 mg/m^2

    Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour.

    Drug: IC83/LY2603618 · Drug: pemetrexed

  • Experimental
    LY2603618 150 mg/m^2

    Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour.

    Drug: IC83/LY2603618 · Drug: pemetrexed

  • Experimental
    LY2603618 195 mg/m^2

    Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.

    Drug: IC83/LY2603618 · Drug: pemetrexed

Interventions

  • DrugIC83/LY2603618

    40 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m\^2.

  • DrugIC83/LY2603618

    70 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.

  • DrugIC83/LY2603618

    105 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.

  • DrugIC83/LY2603618

    150 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.

  • DrugIC83/LY2603618

    195 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles.

  • Drugpemetrexed

    pemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

    Also known as: Alimta, LY231514

  • Drugpemetrexed

    pemetrexed 500 mg/m\^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.

    Time frame: baseline up to 24 months

Secondary outcomes

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618

    Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.

    Time frame: Day 1 and Day 9 of Cycle 1

  2. Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])

    AUC\[0-∞\] was calculated from the plasma concentration data of LY2603618 versus time profiles.

    Time frame: Day 1 and Day 9 of Cycle 1

  3. Percentage of Participants With Best Overall Response

    Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm \* 100.

    Time frame: baseline up to 24 months

07

Results

Posted Oct 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneLY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
Started3331363
Completed232741
Not completed101622
Withdrew: Symptomatic deterioration101201
Withdrew: Adverse event000110
Withdrew: Withdrawal by subject000010
Withdrew: Disease progression000301

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs)

Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.

Time frame:
baseline up to 24 months
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsLY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
Other Non-Serious Adverse Events (AEs)3331363
Serious Adverse Events (SAEs)102842
SecondaryPharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618

Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles.

Time frame:
Day 1 and Day 9 of Cycle 1
Reported as:
Mean · nanograms per millimeter (ng/mL)
Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
nanograms per millimeter (ng/mL)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
Day 1578 ± 1811560 ± 3582310 ± 13304220 ± 13704230 ± 13706840 ± 839
Day 9614 ± 1692010 ± 5812510 ± 9424540 ± 22703560 ± 13207580 ± 1260
SecondaryPharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])

AUC\[0-∞\] was calculated from the plasma concentration data of LY2603618 versus time profiles.

Time frame:
Day 1 and Day 9 of Cycle 1
Reported as:
Mean · nanograms*hour per milliliter (ng*h/mL)
Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
nanograms*hour per milliliter (ng*h/mL)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
Day 17580 ± 79010300 ± 28109510 ± 556076400 ± 6500061900 ± 53300122000 ± 42000
Day 97540 ± 179011000 ± 255010900 ± 628052000 ± 3390055000 ± 45000119000 ± 30300
SecondaryPercentage of Participants With Best Overall Response

Percentage of participants with tumor response (best confirmed overall response) assessed as complete response (CR) or partial response (PR) to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD) =small changes that do not meet above criteria. Best Overall Response (%)=number of participants with CR+PR/number of participants in treatment arm \* 100.

Time frame:
baseline up to 24 months
Reported as:
Number · Percentage of participants
Percentage of Participants With Best Overall Response
Percentage of participantsLY2603618 40 mg/m^2 (4.5 Hours)LY2603618 40 mg/m^2 (1 Hour)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
Complete Response (CR)000000
Partial Response (PR)0001000
Stable Disease (SD)066.750207550
Progressive Disease (PD)10033.350702550
Not Determined000000
Best Overall Response (CR + PR)0001000

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
LY2603618 40 mg/m^2 (4.5-hour Infusion)—1/3 (33.3%)3/3 (100%)
LY2603618 40 mg/m^2 (1-hour Infusion)—0/3 (0%)3/3 (100%)
LY2603618 70 mg/m^2—2/3 (66.7%)3/3 (100%)
LY2603618 105 mg/m^2—8/13 (61.5%)13/13 (100%)
LY2603618 150 mg/m^2—4/6 (66.7%)6/6 (100%)
LY2603618 195 mg/m^2—2/3 (66.7%)3/3 (100%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventLY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
PancytopeniaBlood and lymphatic system disorders0/30/30/30/130/62/3
AnaemiaBlood and lymphatic system disorders0/30/30/31/131/61/3
Cardiac arrestCardiac disorders0/30/31/30/130/60/3
Abdominal painGastrointestinal disorders0/30/31/30/130/60/3
Lower gastrointestinal haemorrhageGastrointestinal disorders0/30/30/30/130/61/3
PyrexiaGeneral disorders0/30/30/31/130/61/3
CellulitisInfections and infestations0/30/31/30/130/60/3
PneumoniaInfections and infestations1/30/30/30/130/60/3
DehydrationMetabolism and nutrition disorders0/30/31/30/130/60/3
AspirationRespiratory, thoracic and mediastinal disorders0/30/31/30/130/60/3
Most frequent other events
Showing 10 of 163
Most frequent other events
EventLY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2
NauseaGastrointestinal disorders2/32/33/37/132/60/3
VomitingGastrointestinal disorders1/30/33/35/133/60/3
FatigueGeneral disorders0/33/33/34/135/62/3
ThrombocytopeniaBlood and lymphatic system disorders0/30/31/31/132/62/3
ConstipationGastrointestinal disorders1/32/31/32/132/60/3
Haemoglobin decreasedInvestigations0/32/30/30/130/60/3
AnorexiaMetabolism and nutrition disorders0/30/32/30/131/60/3
Back painMusculoskeletal and connective tissue disorders1/30/32/31/132/60/3
DysgeusiaNervous system disorders2/31/32/31/130/60/3
TremorNervous system disorders0/32/30/32/130/60/3

Baseline characteristics

Age, Continuous
Age, Continuous(years)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
Mean49.0 ± 6.2458.0 ± 10.5448.3 ± 16.0760.6 ± 9.9563.5 ± 11.0455.7 ± 18.7758.1 ± 11.73
Sex: Female, Male
Sex: Female, Male(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
Female31253115
Male02183216
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
Hispanic or Latino0001001
Not Hispanic or Latino333126330
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
American Indian or Alaska Native0000011
Asian1000001
Native Hawaiian or Other Pacific Islander0000000
Black or African American0010001
White232136228
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
United States333136331
Primary Cancer Type
Primary Cancer Type(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
Breast3110106
Non-small Cell Lung0001001
Pancreatic0003216
Other02293218
Eastern Cooperative Oncology Group (ECOG) Rating at Screening
Eastern Cooperative Oncology Group (ECOG) Rating at Screening(Participants)LY2603618 40 mg/m^2 (4.5-hour Infusion)LY2603618 40 mg/m^2 (1-hour Infusion)LY2603618 70 mg/m^2LY2603618 105 mg/m^2LY2603618 150 mg/m^2LY2603618 195 mg/m^2Total
ECOG Rating 02104108
ECOG Rating 112395323
08

Study locations

1 site
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Scottsdale, Arizona 85258, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00415636
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Dec 25, 2006
Start date
Jan 2007
Primary completion
Mar 2010
Completion
Jul 2010
Results posted
Oct 19, 2018
Last update
Oct 19, 2018

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM 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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