Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2012-04-26
2024-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Galunisertib
* 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.
Galunisertib
Administered orally
Arm B: Galunisertib + Lomustine
* 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.
Galunisertib
Administered orally
Lomustine
Administered orally
Arm C: Lomustine + Placebo
* 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.
Lomustine
Administered orally
Placebo
Administered orally
Interventions
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Galunisertib
Administered orally
Lomustine
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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San Francisco, California, United States
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Cleveland, Ohio, United States
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Dallas, Texas, United States
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St Leonards, New South Wales, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Edegem, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Bobigny, , France
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Lyon, , France
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Marseille, , France
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Nancy, , France
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Paris, , France
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Bonn, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Bologna, , Italy
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Terni, , Italy
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Udine, , Italy
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Lodz, , Poland
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Barcelona, , Spain
Countries
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References
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Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.
Brandes AA, Carpentier AF, Kesari S, Sepulveda-Sanchez JM, Wheeler HR, Chinot O, Cher L, Steinbach JP, Capper D, Specenier P, Rodon J, Cleverly A, Smith C, Gueorguieva I, Miles C, Guba SC, Desaiah D, Lahn MM, Wick W. A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma. Neuro Oncol. 2016 Aug;18(8):1146-56. doi: 10.1093/neuonc/now009. Epub 2016 Feb 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H9H-MC-JBAL
Identifier Type: OTHER
Identifier Source: secondary_id
2011-004418-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13849
Identifier Type: -
Identifier Source: org_study_id
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