Phase 1
Completed N=31
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Source: ClinicalTrials.gov NCT00415636 ↗Enrolled (actual)
31
Serious AEs
54.8%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 3; 3; 3; 13 Participants
Summary
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
3; 3; 3; 13; 6; 3 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618 |
578; 1560; 2310; 4220; 4230; 6840 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) |
7580; 10300; 9510; 76400; 61900; 122000 | — |
| SECONDARY Percentage of Participants With Best Overall Response |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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:
- Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
- 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.
Data sourced from ClinicalTrials.gov (NCT00415636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.