Overview

This trial is active, not recruiting.

Condition glioblastoma
Treatments ly2157299 monohydrate, lomustine, placebo
Phase phase 2
Sponsor Eli Lilly and Company
Start date April 2012
End date July 2014
Trial size 180 participants
Trial identifier NCT01582269, 13849, H9H-MC-JBAL

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
ly2157299 monohydrate LY2157299
Orally administered as tablets
lomustine
Orally administered as capsules
(Experimental)
300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
ly2157299 monohydrate LY2157299
Orally administered as tablets
(Active Comparator)
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.
lomustine
Orally administered as capsules
placebo LY2157299 monohydrate-matched placebo
Orally administered as tablets

Primary Outcomes

Measure
Overall survival
time frame: Date of randomization to date of death from any cause estimated up to 2 years

Secondary Outcomes

Measure
Population Pharmacokinetics (PK): median population clearance
time frame: Cycle 1, Day 1, 3, 14, 15 and 16
Progression free survival (PFS)
time frame: Randomization to the date of objective progression or death from any cause estimated up to 2 years
Percentage of Participants with Tumor Response
time frame: Every 2 cycles to disease progression or participant starts a new anticancer therapy estimated up to 2 years
Change from baseline in neurocognitive function
time frame: Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years
Population Pharmacokinetics (PK): absorption
time frame: Cycle 1, Day 1, 3, 14, 15 and 16
Population Pharmacokinetics (PK): volume of distribution
time frame: Cycle 1, Day 1, 3, 14, 15 and 16
Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score
time frame: Baseline, cycle 1, cycle 2 then every 2 cycles to 30 day post discontinuation follow up estimated up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.
Location data was received from the National Cancer Institute and was last updated in July 2016.