Phase 1
N=3
C14 Study in Oncology Patients With Advanced and/or Metastatic Solid Tumors
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01296568 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Urinary and Fecal Excretion of LY2603618 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 72.2; 11.0 percentage of total dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY2603618 (Drug); Pemetrexed (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary and Fecal Excretion of LY2603618 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
72.2; 11.0 | — |
| SECONDARY Plasma Pharmacokinetics of LY2603618: Maximum Observed Drug Concentration (Cmax) |
4750 | — |
| SECONDARY Plasma Pharmacokinetics of Radioactivity: Maximum Observed Drug Concentration (Cmax) |
5660 | — |
| SECONDARY Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)] |
22300 | — |
| SECONDARY Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Infinity [AUC(0-infinity)] |
32500 | — |
| SECONDARY Plasma Pharmacokinetics of LY2603618: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)] |
22200 | — |
| SECONDARY Plasma Pharmacokinetics of Radioactivity: Area Under the Concentration Time Curve From Time Zero to Time t [AUC(0-tlast)] |
27700 | — |
| SECONDARY Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Urine |
3.3; 3.0 | — |
| SECONDARY Relative Abundance of LY2603618 and the Metabolites of LY2603618 in Feces |
5.6; 61.4 | — |
| SECONDARY The Number of Participants With a Tumor Response |
0; 0; 2; 0 | — |
Summary
This is an open-label study being conducted to determine the metabolism and physiological disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or metastatic solid tumors.
After a minimum 7-day washout period following the carbon-14-labeled LY2603618 ([^14C]LY2603618) dose, patients will be allowed to continue to receive continued access to LY2603618 in combination with pemetrexed or gemcitabine as outpatients.
Eligibility Criteria
Inclusion Criteria
- Have a histological or cytological diagnosis of cancer (solid tumor), with clinical or radiologic evidence of locally advanced and/or metastatic disease, for which no life-prolonging therapy exists (that is, refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists). Note: participants who have had progressive disease after receiving pemetrexed for metastatic disease are excluded from receiving the combination with pemetrexed during the safety extension study. Participants who have had progressive disease after receiving gemcitabine for metastatic disease are excluded from receiving the combination with gemcitabine during the safety extension study.
- Have a body surface area greater than or equal to 1.37 meters squared (m^2)
- Have given written informed consent prior to any study-specific procedures
- Adequate hematologic, hepatic and renal function
- Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous treatments for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 30 days prior to study entry and recovered from the acute effects of therapy (at least 42 days for mitomycin-C or nitrosoureas, or 60 days for monoclonal antibodies)
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedure
- Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and following the last dose of study drug until, in the judgment of the investigator, it is safe for the participant to become pregnant or father a child
- Females with childbearing potential: Have had a negative serum pregnancy test less than or equal to 7 days before the first dose of study drug and must also not be breastfeeding
- Have an estimated life expectancy that, in the judgment of the investigator, will permit the participant to complete 1 full cycle of treatment (beyond the initial [^14C]LY2603618 dose)
- Prior radiation therapy for treatment of cancer other than pancreatic is allowed to 500 milliseconds (msec) on the screening electrocardiogram (ECG)
- Have ECG abnormalities on the screening ECG such as significant conduction abnormalities, ischemic changes (such as prior Q-wave myocardial infarction and/or marked ischemic ST- and T-wave), arrhythmias (such as persistent or paroxysmal ventricular or supraventricular arrhythmias, including atrial fibrillation), or other ECG abnormalities that would put the participant at unnecessary risk in the opinion of the investigator
- Have participated in a ^14C study within the last 6 months prior to screening for this study. The total exposure from this study and the previous study must be less than 5 milliSieverts (mSv).
Data sourced from ClinicalTrials.gov (NCT01296568). 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.