Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
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.
DRUGpemetrexed
pemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | baseline up to 24 months | Summary tables of serious AEs (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 and Day 9 of Cycle 1 | Cmax was estimated from the plasma concentration data of LY2603618 versus time profiles. |
| Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 and Day 9 of Cycle 1 | AUC\[0-∞\] was calculated from the plasma concentration data of LY2603618 versus time profiles. |
| Percentage of Participants With Best Overall Response | baseline up to 24 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| LY2603618 40 mg/m^2 (1-hour Infusion) Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), 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. | 3 |
| 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. | 3 |
| LY2603618 105 mg/m^2 LY2603618 105 mg/m\^2 administered over the duration of 1 hour. | 13 |
| LY2603618 150 mg/m^2 LY2603618 150 mg/m\^2 administered over the duration of 1 hour. | 6 |
| LY2603618 195 mg/m^2 LY2603618 195 mg/m\^2 administered over the duration of 1 hour. | 3 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Disease progression | 0 | 0 | 0 | 3 | 0 | 1 |
| Overall Study | Symptomatic deterioration | 1 | 0 | 1 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | LY2603618 40 mg/m^2 (1-hour Infusion) | LY2603618 70 mg/m^2 | LY2603618 105 mg/m^2 | LY2603618 40 mg/m^2 (4.5-hour Infusion) | LY2603618 150 mg/m^2 | LY2603618 195 mg/m^2 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 10.54 | 48.3 years STANDARD_DEVIATION 16.07 | 60.6 years STANDARD_DEVIATION 9.95 | 49.0 years STANDARD_DEVIATION 6.24 | 63.5 years STANDARD_DEVIATION 11.04 | 55.7 years STANDARD_DEVIATION 18.77 | 58.1 years STANDARD_DEVIATION 11.73 |
| Eastern Cooperative Oncology Group (ECOG) Rating at Screening ECOG Rating 0 | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 8 Participants |
| Eastern Cooperative Oncology Group (ECOG) Rating at Screening ECOG Rating 1 | 2 Participants | 3 Participants | 9 Participants | 1 Participants | 5 Participants | 3 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 12 Participants | 3 Participants | 6 Participants | 3 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Primary Cancer Type Breast | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 6 Participants |
| Primary Cancer Type Non-small Cell Lung | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Primary Cancer Type Other | 2 Participants | 2 Participants | 9 Participants | 0 Participants | 3 Participants | 2 Participants | 18 Participants |
| Primary Cancer Type Pancreatic | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 13 Participants | 2 Participants | 6 Participants | 2 Participants | 28 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants | 13 Participants | 3 Participants | 6 Participants | 3 Participants | 31 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 8 Participants | 0 Participants | 3 Participants | 2 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 | 13 / 13 | 6 / 6 | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 2 / 3 | 8 / 13 | 4 / 6 | 2 / 3 |
Outcome results
Primary
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
Population: The safety population was comprised of all participants who received any amount of LY2603618.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 3 Participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 1 Participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 3 Participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 0 Participants |
| LY2603618 70 mg/m^2 | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 3 Participants |
| LY2603618 70 mg/m^2 | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 2 Participants |
| LY2603618 105 mg/m^2 | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 13 Participants |
| LY2603618 105 mg/m^2 | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 8 Participants |
| LY2603618 150 mg/m^2 | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 6 Participants |
| LY2603618 150 mg/m^2 | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 4 Participants |
| LY2603618 195 mg/m^2 | Number of Participants With Adverse Events (AEs) | Other Non-Serious Adverse Events (AEs) | 3 Participants |
| LY2603618 195 mg/m^2 | Number of Participants With Adverse Events (AEs) | Serious Adverse Events (SAEs) | 2 Participants |
Secondary
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
Population: A modified intent-to-treat population (mITT) was used to summarize the data for tumor response. The mITT population consisted of all participants who received any dose of study drug and had at least 1 nonmissing postbaseline tumor response assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Partial Response (PR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 100 Percentage of participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Partial Response (PR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 33.3 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 66.7 Percentage of participants |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 0 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 50 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 50 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
| LY2603618 70 mg/m^2 | Percentage of Participants With Best Overall Response | Partial Response (PR) | 0 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 70 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Partial Response (PR) | 10 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 20 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 10 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 105 mg/m^2 | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Partial Response (PR) | 0 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 75 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 25 Percentage of participants |
| LY2603618 150 mg/m^2 | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 0 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Progressive Disease (PD) | 50 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Stable Disease (SD) | 50 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Not Determined | 0 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Best Overall Response (CR + PR) | 0 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Partial Response (PR) | 0 Percentage of participants |
| LY2603618 195 mg/m^2 | Percentage of Participants With Best Overall Response | Complete Response (CR) | 0 Percentage of participants |
Secondary
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
Population: Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 7540 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 1790 |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 7580 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 790 |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 10300 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 2810 |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 11000 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 2550 |
| LY2603618 70 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 9510 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 5560 |
| LY2603618 70 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 10900 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 6280 |
| LY2603618 105 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 76400 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 65000 |
| LY2603618 105 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 52000 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 33900 |
| LY2603618 150 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 61900 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 53300 |
| LY2603618 150 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 55000 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 45000 |
| LY2603618 195 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 9 | 119000 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 30300 |
| LY2603618 195 mg/m^2 | Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) | Day 1 | 122000 nanograms*hour per milliliter (ng*h/mL) | Standard Deviation 42000 |
Secondary
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
Population: Pharmacokinetic (PK) analyses were conducted for individual participants who received at least 1 dose of study drug and had PK samples collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 578 nanograms per millimeter (ng/mL) | Standard Deviation 181 |
| LY2603618 40 mg/m^2 (4.5-hour Infusion) | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 614 nanograms per millimeter (ng/mL) | Standard Deviation 169 |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 1560 nanograms per millimeter (ng/mL) | Standard Deviation 358 |
| LY2603618 40 mg/m^2 (1-hour Infusion) | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 2010 nanograms per millimeter (ng/mL) | Standard Deviation 581 |
| LY2603618 70 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 2310 nanograms per millimeter (ng/mL) | Standard Deviation 1330 |
| LY2603618 70 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 2510 nanograms per millimeter (ng/mL) | Standard Deviation 942 |
| LY2603618 105 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 4220 nanograms per millimeter (ng/mL) | Standard Deviation 1370 |
| LY2603618 105 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 4540 nanograms per millimeter (ng/mL) | Standard Deviation 2270 |
| LY2603618 150 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 4230 nanograms per millimeter (ng/mL) | Standard Deviation 1370 |
| LY2603618 150 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 3560 nanograms per millimeter (ng/mL) | Standard Deviation 1320 |
| LY2603618 195 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 1 | 6840 nanograms per millimeter (ng/mL) | Standard Deviation 839 |
| LY2603618 195 mg/m^2 | Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 | Day 9 | 7580 nanograms per millimeter (ng/mL) | Standard Deviation 1260 |