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

Lilly

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: IC83/LY2603618; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415636

11911

I2I-MC-JMMB (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618

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

Experimental group

Description:

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.

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618

LY2603618 70 mg/m^2

Experimental group

Description:

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.

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618

LY2603618 105 mg/m^2

Experimental group

Description:

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

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618

LY2603618 150 mg/m^2

Experimental group

Description:

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

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618

LY2603618 195 mg/m^2

Experimental group

Description:

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

Treatment:

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: IC83/LY2603618

Drug: pemetrexed

Drug: pemetrexed

Drug: IC83/LY2603618

Drug: IC83/LY2603618