Clinical trial · Interventional
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
NCT00415636CI-TRIAL-00035374completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IC83/LY2603618 | Drug | — | UNRESOLVED |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- LY2603618 40 mg/m^2 (4.5-hour infusion)
- 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.
- interventionNames
- Drug: IC83/LY2603618
- Drug: pemetrexed
- type
- EXPERIMENTAL
- label
- LY2603618 40 mg/m^2 (1-hour infusion)
- 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.
- interventionNames
- Drug: IC83/LY2603618
- Drug: pemetrexed
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.