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Phase 1 Dose-Escalation Study of LY2157299 Monotherapy and in Combination With Lomustine in Patients With Recurrent Malignant Glioma

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Phase 1 Dose-Escalation Study of LY2157299 Monotherapy and in Combination With Lomustine in Patients With Recurrent Malignant Glioma

Inclusion Criteria:

- Have given written informed consent

- Have histological or cytological evidence of relapsed malignant glioma (such as
glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma) for
which no treatment of higher priority exists

- Available baseline tumor specimen is required prior to considering participant
to be enrolled. The original diagnostic tumor tissue is sufficient for this
inclusion criteria, but where possible, freshly obtained tumor biopsy material
may be obtained

- Measurable disease to allow assessment of tumor response based on radiographic
assessment following Macdonald criteria and Response Evaluation Criteria In
Solid Tumors (RECIST)

- Have sufficient hepatic, renal, and hematological function

- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG)

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy or other investigational therapy for at least 30 days prior to study
enrollment and recovered from the acute effects of therapy

- Able to swallow tablets and capsules

- For females, reproductive potential must be either terminated (by surgery, radiation,
or menopause) or attenuated by the use of an approved contraceptive method (including
intrauterine or barrier devices) during and for 3 to 6 months after the study

- Male participants must be willing to use contraception during and for 3 to 6 months
after the study

Exclusion Criteria:

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry

- Have moderate or severe cardiac disease:

- Have the presence of cardiac disease, including a myocardial infarction within 6
months prior to study entry, unstable angina pectoris, New York Heart
Association (NYHA) Class III/IV congestive heart failure, or uncontrolled

- Have documented major electrocardiogram (ECG) abnormalities at the
investigator's discretion (for example, symptomatic or sustained atrial or
ventricular arrhythmias, second- or third-degree atrioventricular block, bundle
branch blocks, ventricular hypertrophy, or recent myocardial infarction)

- Have major abnormalities documented by echocardiography with Doppler (for
example, moderate or severe heart valve function defect and/or left ventricular
ejection fraction (LVEF) <50%, evaluation based on the institutional lower limit
of normal)

- Have predisposing conditions that are consistent with development of aneurysms
of the ascending aorta or aortic stress (for example, family history of
aneurysms, Marfan syndrome, bicuspid aortic valve, evidence of damage to the
large vessels of the heart documented by computerized tomography [CT] scan with

- Have current acute or chronic leukemia

- Women who are pregnant or lactating

- Have received prior nitrosourea (including lomustine) therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Dose for Phase 2 Studies

Outcome Time Frame:

Time of first dose to time of last dose (estimated up to 8 years)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

May 2012

Related Keywords:

  • Glioma
  • Glioma



For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bethesda, Maryland  20817