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A Study in Recurrent Glioblastoma (GB)
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01582269
First received: April 19, 2012
Last updated: March 29, 2017
Last verified: March 2017
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Glioblastoma | Drug: LY2157299 monohydrate Drug: Lomustine Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Overall survival [ Time Frame: Date of randomization to date of death from any cause estimated up to 2 years ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 180 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2017 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LY2157299 monohydrate plus lomustine
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. |
Drug: LY2157299 monohydrate
Orally administered as tablets
Other Name: LY2157299
Drug: Lomustine
Orally administered as capsules
|
|
Experimental: LY2157299 monohydrate
300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
|
Drug: LY2157299 monohydrate
Orally administered as tablets
Other Name: LY2157299
|
|
Active Comparator: lomustine plus placebo
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. |
Drug: Lomustine
Orally administered as capsules
Drug: Placebo
Orally administered as tablets
Other Name: LY2157299 monohydrate-matched placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01582269
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582269
Show 27 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01582269 History of Changes |
| Other Study ID Numbers: |
13849 H9H-MC-JBAL ( Other Identifier: Eli Lilly and Company ) |
| Study First Received: | April 19, 2012 |
| Last Updated: | March 29, 2017 |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lomustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 22, 2017