A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Eligible male and female patients are required to: (1) have confirmed diagnosis of relapsed intracranial or secondary blioblastoma, 2) evidence of tumor progression , 3) may have undergone prior surgical resection and will be eligible if patients have recovered from the effects of surgery and evaluable or measurable disease is present , 4) have available tumor tissue, 5)have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, 6) Have discontinued all previous treatments for cancer excluding palliative treatments and recovered from the acute effects of therapy , 7) Have adequate organ function,8)Are males or females at least 18 years old at the time of screening: Females must be women of child-bearing potential who test negative for pregnancy (at the time of enrollment) or postmenopausal women - Males must agree to use a reliable method of birth control (during the study and for at least 12 weeks following last dose of study drug), 8) Have given written informed consent/assent prior to any study-specific procedures, 9) Are able to swallow capsules (lomustine) and tablets (LY2157299/placebo).

Exclusion Criteria

Patients should not enter the study if any of the following exclusion criteria are fulfilled;1) Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product (including vascular endothelial growth factor receptor [VEGF-R] inhibitors) or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
2) Have previously completed or withdrawn from this study or any other study investigating LY2157299.
3) Have moderate or severe cardiac disease
4) Received prior nitrosourea (including lomustine or Gliadel®/local carmustine) therapy.
5) Received prior bevacizumab as part of a first-line treatment for GB (unless the treatment was concluded 12 months prior to enrollment)
6) Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient*s ability to adhere to the protocol.
7) Have current acute or chronic myelogenous leukemia
8) Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results
9) Are pregnant or breast-feeding women
10) Are unwilling or unable to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the overall survival (OS) distributions between LY2157299 plus<br /><br>lomustine therapy and lomustine plus placebo therapy (control arm) in patients<br /><br>who have relapsed or have progressive GB after first-line treatment with<br /><br>chemoradiation. </p><br>

Secondary Outcome Measures