A Study in Recurrent Glioblastoma (GB)

Lilly

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Lomustine; Drug: Galunisertib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582269

H9H-MC-JBAL (Other Identifier)

2011-004418-40 (EudraCT Number)

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: 158 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: Double Blind

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158 participants in 3 patient groups

Arm A: Galunisertib

Experimental group

Description:

* Participants received Galunisertib 300 milligrams (mg) orally twice daily (BID) for 14 days, followed by 14 days of rest in a 28-day cycle. * Treatment continued until disease progression, death, or discontinuation criteria were met.

Treatment:

Drug: Galunisertib

Arm B: Galunisertib + Lomustine

Experimental group

Description:

* Participants received Galunisertib 300 mg orally BID for 14 days, followed by 14 days of rest in a 28-day cycle. * Participants received a first dose of Lomustine at 100 milligrams per square meter (mg/m²) administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator. * Treatment continued until disease progression, death, or discontinuation criteria were met.

Treatment:

Drug: Galunisertib

Drug: Lomustine

Arm C: Lomustine + Placebo

Active Comparator group

Description:

* Participants received a first dose of Lomustine at 100 mg/m² administered orally. Thereafter, starting with the second dose, Lomustine was administered orally once every 6 weeks at 100-130 mg/m², at the discretion of the investigator. * Participants received Galunisertib-matched Placebo orally BID for 14 days, followed by 14 days of rest in a 28-day cycle. * Treatment continued until disease progression, death, or discontinuation criteria were met.

Treatment:

Drug: Placebo

Drug: Lomustine