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IC83/LY2603618

Phase 1

Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Oct 19, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

IC83/LY2603618 · 1 trial · 1 indication

Phase 1 1
NCT00415636Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With CancerCancer
COMPLETED31 Analytics
PHASE1COMPLETED
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
Day 1 and Day 9 of Cycle 1
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
Percentage of Participants With Best Overall Response
baseline up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2603618 40 mg/m^2 (4.5-hour infusion)EXPERIMENTALLY2603618 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.
LY2603618 40 mg/m^2 (1-hour infusion)EXPERIMENTALBased 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.
LY2603618 70 mg/m^2EXPERIMENTALBeginning 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.
LY2603618 105 mg/m^2EXPERIMENTALCohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour.
LY2603618 150 mg/m^2EXPERIMENTALCohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour.
LY2603618 195 mg/m^2EXPERIMENTALCohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.

Interventions

NameTypeDescription
IC83/LY2603618DRUG40 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.
pemetrexedDRUGpemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about IC83/LY2603618

What is IC83/LY2603618 used for?

IC83/LY2603618 is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with cancer to evaluate its safety and tolerability.

Who makes IC83/LY2603618?

IC83/LY2603618 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in cancer patients.

What phase is IC83/LY2603618 in?

IC83/LY2603618 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of cancer.

What clinical trials is IC83/LY2603618 in?

IC83/LY2603618 has been studied in one completed Phase 1 clinical trial, identified as NCT00415636. This trial evaluated the safety and tolerability of IC83/LY2603618 administered after pemetrexed 500 mg/m2 every 21 days in patients with cancer. The trial enrolled 31 participants in the United States.

Is IC83/LY2603618 the same as LY2603618?

Yes, IC83/LY2603618 is the same drug as LY2603618. The name IC83/LY2603618 combines the investigational code IC83 with the Eli Lilly identifier LY2603618. Both names refer to the same investigational small molecule being developed for cancer treatment.