Phase 2
Completed N=50
A Study for Participants With Pancreatic Cancer
Source: ClinicalTrials.gov NCT00839332 ↗Enrolled (actual)
50
Serious AEs
44.3%
Results posted
Apr 2018
Primary outcomePrimary: Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine — 230 milligrams (mg)
Summary
The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment for participants with pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine |
230 | — |
| PRIMARY Phase 2: Overall Survival (OS) |
7.8; 8.3 | — |
| SECONDARY Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618 |
3530; 3360; 3100; 4890; 5170; 5360 | — |
| SECONDARY Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618 |
3170; 3410; 2390 | — |
| SECONDARY Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618 |
21300; 21200; 19900; 40500; 50100; 49800 | — |
| SECONDARY Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618 |
23200; 23700; 19800; 22200; 20800; 20100 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) |
3.5; 5.6 | — |
| SECONDARY Phase 2: Overall Response Rate |
21.5; 8.8 | — |
| SECONDARY Phase 2: Clinical Benefit Rate |
55.4; 64.7 | — |
| SECONDARY Phase 2: Duration of Response |
3.5; 6.0 | — |
| SECONDARY Phase 1: Electrocardiogram QTc Prolongation |
2; 1; 0; 2; 0; 0 | — |
| SECONDARY Phase 2: Electrocardiogram QTc Prolongation |
55; 5; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with cancer that is metastatic and/or advanced during Phase 1
- Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
- Must be at least 18 years of age
- Adequate hematological, liver, and renal functions
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Exclusion Criteria
- Known hypersensitivity to gemcitabine
- Pregnant or lactating females or refusal to use medically approved contraceptive precautions
- Had prior treatment with radiotherapy involving more than 25% of marrow producing area
- Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
Data sourced from ClinicalTrials.gov (NCT00839332). 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.