Phase 2
N=103
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
Ovarian Cancer · Non Small Cell Lung Cancer · Prostate Cancer · Colorectal Cancer · Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01059643 ↗Enrolled (actual)
103
Serious AEs
37.9%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Participants With a Complete Response (CR) or Partial Response (PR) — 0; 0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2523355 (Drug); pegfilgrastim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
1.30; 1.25; 1.31; 1.31; 2.30; 1.51 | — |
| SECONDARY Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
37.5; 16.7; 38.5; 30.8; 47.1; 50.0 | — |
| SECONDARY Tumor Marker Values as Relevant to Specific Tumor Types at Baseline |
2; 15; 9; 7; 1; 1 | — |
| SECONDARY Change in Tumor Size at Smallest Size (Best Response) |
15.4; 29.0; 21.9; 22.1; 12.2; 3.9 | — |
| SECONDARY Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 |
125; 124; 5.0; 5.3 | — |
| SECONDARY Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 |
1.02; 1.08 | — |
Summary
The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
- Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Are willing to follow study procedures for the duration of the study
- Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
Exclusion Criteria
- Have a serious preexisting medical condition that would preclude participation in the study
- Are pregnant or lactating
- Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
- Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
- Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
- Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
- Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
- Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
Data sourced from ClinicalTrials.gov (NCT01059643). 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.