Solid Tumors
Conditions
Keywords
Solid tumors
Brief summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy.
Interventions
DRUGLY573636
Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\].
DRUGPemetrexed
375 to 500 milligrams per square meter (mg/m\^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You must have a diagnosis of a solid tumor malignancy that is not amenable to curative therapy * You must have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) \[30 grams per liter (g/L)\] * You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures * Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drugs * Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory * You must be willing to take folic acid, Vitamin B12, or prophylactic steroids * You must able to interrupt the use of aspirin (other than an aspirin dose less than or equal to 1.3 grams per day) and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam) * You must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). Patients who have received whole-brain radiation must wait 90 days before starting study therapy. * You must sign an informed consent
Exclusion criteria
* You cannot have received other investigational drugs within the last 30 days * You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections * You cannot require regular, periodic paracentesis or thoracentesis * You cannot have active brain metastasis * You cannot currently be receiving warfarin (Coumadin®) therapy * You cannot be pregnant or lactating * You cannot have received prior pemetrexed or LY573636 * You cannot have a second primary malignancy that could affect interpretation of the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase 2 Dose | Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)] | Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where \<33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Baseline to end of study (up to 1 year of treatment plus 30-day follow-up) | Clinically significant effects were defined as serious and other non-serious adverse events (AEs) regardless of causality. A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module. |
| Percentage of Participants With a Tumor Response | Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up) | Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and confirmed by repeat assessment. Complete Response (CR) was defined as the disappearance of all target lesions and the normalization of tumor marker levels for non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. Percentage of participants with a tumor response = (number of participants with CR or PR/number of enrolled participants)\*100. |
| Pharmacokinetics, Concentration Maximum (Cmax) of LY573636 | Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime) | — |
| Pharmacokinetics, Area Under the Curve (AUC) of LY573636 | Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime) | Area under the concentration-time curve above the albumin corrected threshold (AUCalb) is provided for LY573636, which has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. |
Countries
United States
Participant flow
Pre-assignment details
Study planned for dose-escalation followed by dose-confirmation phase. Enrollment stopped before anyone entered dose-confirmation phase. Participant (pt) Flow presents pt disposition during dose-escalation & provide reasons for pts who discontinued treatment. All pts who received atleast 1dose of study drug were considered to have completed study.
Participants by arm
| Arm | Count |
|---|---|
| LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1 Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 1 |
| LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1 Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 5 |
| LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 3 |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 6 |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4 Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 6 |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4 Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 4 |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met | 9 |
| Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 3 |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4 Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met. | 2 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 0 | 0 | 3 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 0 | 2 | 1 | 2 | 5 | 4 | 5 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 2 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1 | LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1 | LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 | LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 | LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4 | Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4 | Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.63 years | 63.13 years STANDARD_DEVIATION 11.54 | 60.36 years STANDARD_DEVIATION 9.39 | 60.91 years STANDARD_DEVIATION 10.47 | 59.52 years STANDARD_DEVIATION 11 | 58.26 years STANDARD_DEVIATION 6.22 | 50.50 years STANDARD_DEVIATION 14.55 | 65.26 years STANDARD_DEVIATION 5.8 | 68.27 years STANDARD_DEVIATION 0.07 | 59.02 years STANDARD_DEVIATION 11.25 |
| Race/Ethnicity, Customized African | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants | 5 Participants | 3 Participants | 5 Participants | 6 Participants | 3 Participants | 7 Participants | 2 Participants | 2 Participants | 34 Participants |
| Race/Ethnicity, Customized East Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 1 Participants | 5 Participants | 3 Participants | 6 Participants | 6 Participants | 4 Participants | 9 Participants | 3 Participants | 2 Participants | 39 Participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 1 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 2 Participants | 0 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 13 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 5 / 5 | 3 / 3 | 6 / 6 | 6 / 6 | 4 / 4 | 9 / 9 | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 1 / 1 | 4 / 5 | 2 / 3 | 4 / 6 | 3 / 6 | 3 / 4 | 4 / 9 | 3 / 3 | 2 / 2 |
Outcome results
Primary
Recommended Phase 2 Dose
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where \<33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.
Time frame: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]
Population: Enrollment was stopped during the dose-escalation phase and it was too early to assess the recommended dose for Phase 2 or to estimate the MTD, therefore zero participants were analyzed.
Secondary
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and other non-serious adverse events (AEs) regardless of causality. A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Time frame: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Population: All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pemetrexed Followed by LY573636 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 1 Participants |
| Pemetrexed Followed by LY573636 | Number of Participants With Clinically Significant Effects | Serious AEs | 1 Participants |
| LY573636 Followed by Pemetrexed | Number of Participants With Clinically Significant Effects | Serious AEs | 4 Participants |
| LY573636 Followed by Pemetrexed | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 5 Participants |
| LY573636 and Pemetrexed on Day 1 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 3 Participants |
| LY573636 and Pemetrexed on Day 1 | Number of Participants With Clinically Significant Effects | Serious AEs | 2 Participants |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 4 Participants |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 6 Participants |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 3 Participants |
| LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 6 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 4 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 3 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 4 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 9 Participants |
| Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 3 Participants |
| Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 3 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Non-Serious AEs | 2 Participants |
| Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4 | Number of Participants With Clinically Significant Effects | Serious AEs | 2 Participants |
Secondary
Percentage of Participants With a Tumor Response
Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and confirmed by repeat assessment. Complete Response (CR) was defined as the disappearance of all target lesions and the normalization of tumor marker levels for non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. Percentage of participants with a tumor response = (number of participants with CR or PR/number of enrolled participants)\*100.
Time frame: Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)
Population: All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed Followed by LY573636 | Percentage of Participants With a Tumor Response | 0.0 percentage of participants |
| LY573636 Followed by Pemetrexed | Percentage of Participants With a Tumor Response | 13.3 percentage of participants |
| LY573636 and Pemetrexed on Day 1 | Percentage of Participants With a Tumor Response | 0.0 percentage of participants |
Secondary
Pharmacokinetics, Area Under the Curve (AUC) of LY573636
Area under the concentration-time curve above the albumin corrected threshold (AUCalb) is provided for LY573636, which has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.
Time frame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
Population: Participants who had at least 1 evaluable AUCalb pharmacokinetic sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed Followed by LY573636 | Pharmacokinetics, Area Under the Curve (AUC) of LY573636 | Cycle 1 | 132.783 hour*micrograms per milliliter (h*µg/mL) | Geometric Coefficient of Variation 265.75 |
| Pemetrexed Followed by LY573636 | Pharmacokinetics, Area Under the Curve (AUC) of LY573636 | Cycle 2 | 68.813 hour*micrograms per milliliter (h*µg/mL) | Geometric Coefficient of Variation 1840.9 |
Secondary
Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
Time frame: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)
Population: Participants who had at least 1 evaluable Cmax pharmacokinetic sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed Followed by LY573636 | Pharmacokinetics, Concentration Maximum (Cmax) of LY573636 | Cycle 1 | 264.285 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 18.465 |
| Pemetrexed Followed by LY573636 | Pharmacokinetics, Concentration Maximum (Cmax) of LY573636 | Cycle 2 | 225.588 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 24.061 |