A Study in Recurrent Glioblastoma (GB)

Lilly

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: LY2157299 monohydrate; Drug: Placebo; Drug: Lomustine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582269

H9H-MC-JBAL (Other Identifier)

13849

Details and patient eligibility

About

The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological confirmed diagnosis of relapsed intracranial GB
• Progressive Disease (PD) following standard chemoradiation
• Prior surgical resection allowed
• Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Adequate hematologic, hepatic and renal function
• Discontinued all prior cancer treatments for cancer & recovered from the acute effects of therapy
• Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation

Exclusion criteria

• Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
• Prior nitrosurea therapy (including lomustine or Gliadel)
• Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
• Current acute or chronic myelogenous leukemia
• Second primary malignancy that may affect the interpretation of results
• Serious concomitant systemic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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151 participants in 3 patient groups

LY2157299 monohydrate plus lomustine

Experimental group

Description:

300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle. First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2.

Treatment:

Drug: Lomustine

Drug: LY2157299 monohydrate

LY2157299 monohydrate

Experimental group

Description:

300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)

Treatment:

Drug: LY2157299 monohydrate

lomustine plus placebo

Active Comparator group

Description:

First lomustine dose will be given as 100 mg/m2 on day 7 cycle 1. Remaining doses are based on the investigator's discretion and will be given orally once every 6 weeks in capsules to equal 100 to 130 mg/m2. LY2157299 monohydrate-matched placebo, given orally as tablets for 14 days, followed by 14 days of rest, equaling a 28-day cycle.

Treatment:

Drug: Lomustine

Drug: Placebo