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A Study in Recurrent Glioblastoma (GB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582269
Recruitment Status : Active, not recruiting
First Posted : April 20, 2012
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: LY2157299 monohydrate Drug: Lomustine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : April 26, 2012
Actual Primary Completion Date : July 26, 2014
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Lomustine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Date of randomization to date of death from any cause estimated up to 2 years ]

Secondary Outcome Measures :
  1. Population Pharmacokinetics (PK): median population clearance [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ]
  2. Progression free survival (PFS) [ Time Frame: Randomization to the date of objective progression or death from any cause estimated up to 2 years ]
  3. 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 ]
  4. 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 ]
  5. Population Pharmacokinetics (PK): absorption [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ]
  6. Population Pharmacokinetics (PK): volume of distribution [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ]
  7. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582269


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Locations
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United States, Alabama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35294
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
La Jolla, California, United States, 92093
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Francisco, California, United States, 94143
United States, Ohio
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Cleveland, Ohio, United States, 44195
United States, Texas
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Dallas, Texas, United States, 75246
Australia, New South Wales
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St. Leonards, New South Wales, Australia, 2065
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
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Parkville, Victoria, Australia, 3050
Belgium
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Liège, Belgium, 4000
Canada, Ontario
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
France
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Bobigny, France, 93009
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Lyon, France, 69394
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Marseille, France, 13385
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Nancy, France, 54035
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Paris, France, 75651
Germany
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Bonn, Germany, 53105
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Frankfurt, Germany, 60596
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Hamburg, Germany, 20246
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Heidelberg, Germany, 69120
Italy
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Bologna, Italy, 40139
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Terni, Italy, 05100
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Udine, Italy, 33100
Poland
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Lodz, Poland, 93-509
Spain
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Barcelona, Spain, 08035
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018
Additional relevant MeSH terms:
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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