Phase 1
N=63
A Dose-Escalation Study for Patients With Advanced Cancer
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01214642 ↗Enrolled (actual)
63
Serious AEs
34.9%
Results posted
Aug 2018
Primary outcome: Primary: Recommended Dose and Schedule for Phase 2 Studies — 8 mg/m^2/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- pegfilgrastim (Drug); LY2523355 (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 Recommended Dose and Schedule for Phase 2 Studies |
8 | — |
| SECONDARY Number of Participants With Clinically Significant Effects |
1; 2; 2; 2; 1; 0 | — |
| SECONDARY Pharmacokinetics Maximum Concentration (Cmax), Single Dose |
45.2; 126; 137; 196; 218; 192 | — |
| SECONDARY Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose |
49.1; 121; 196; 124; 200; 186 | — |
| SECONDARY Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose |
158; 517; 584; 648; 758; 669 | — |
| SECONDARY Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose |
172; 377; 718; 356; 717; 575 | — |
| SECONDARY Number of Participants With Tumor Response |
0; 0; 0; 0 | — |
Summary
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering the dose confirmation phase (Part B) of the study must also have a tumor that is safely amenable to serial biopsies
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or Revised International Working Group Lymphoma Response Criteria
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
- Females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
- Have an estimated life expectancy of greater than or equal to 12 weeks.
Exclusion Criteria
- Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
- Have current acute or chronic leukemia
- Have had an autologous or allogenic bone marrow transplant
- Females who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT01214642). 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.