Have a histologic or cytologic diagnosis of advanced or metastatic malignancies for which no life-prolonging therapy exists and have been previously enrolled and completed therapy in an enzastaurin clinical pharmacology and biopharmaceutics study.
Conditions
Interventions
Product Name: Enzastaurin
Product Code: LY317615
Pharmaceutical Form: Tablet
INN or Proposed INN: Enzastaurin Hydrochloride
Current Sponsor code: LY317615
Concentration unit: mg milligram(s)
Concentra
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have previously been enrolled and completed protocol therapy in an enzastaurin clinical pharmacology and biopharmaceutics study. [2] Have a histologic or cytologic diagnosis of advanced or metastatic malignancies or which no life-prolonging therapy exists. This may include patients with treated, stable brain metastases. [3] Have measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) (Protocol Attachment S001.4). [4] Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Protocol Attachment S001.2). [5] Have adequate bone marrow reserve and organ function as follows: • Absolute neutrophil count (ANC) >1.5 x 109/L and platelets >100 x 109/L. • Hepatic: Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [11] Have received treatment within the last 30 days with a drug other than enzastaurin that has not received regulatory approval for any indication at the time of study entry. [12] Women who are pregnant or breastfeeding. [13] Symptomatic central nervous system (CNS) neoplasm. (Patients who have stable CNS neoplasm on steroid medication may be included.) [14] Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator). [15] Second primary malignancy that could affect compliance with the protocol or interpretation of the results. Patients with adequately treated basal cell carcinoma of the skin or who have had another malignancy in the past, but have been disease-free for more than 2 years, are eligible. [16] Electrocardiogram (ECG) abnormalities indicative of cardiac disease (at the discretion of the investigator). [17] For patients receiving EIAEDs: Patients must discontinue EIAEDs at least 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs (see Attachment S001.5). However if a patient requires EIAED therapy while on study, the patient will not be discontinued from the study. [18] Inability to swallow tablets. [19] Concurrent administration of any other antitumor therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect further basic safety data on patients with advanced or metastatic malignancies treated with enzastaurin.;Secondary Objective: To document antitumor activity that may be observed with enzastaurin. ;Primary end point(s): | — |
Countries
United Kingdom
Outcome results
None listed