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A Study in Recurrent Glioblastoma (GB)

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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

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE April 26, 2012
Actual Primary Completion Date July 26, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Overall survival [ Time Frame: Date of randomization to date of death from any cause estimated up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01582269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Recurrent Glioblastoma (GB)
Official Title  ICMJE A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: LY2157299 monohydrate
    Orally administered as tablets
    Other Name: LY2157299
  • Drug: Lomustine
    Orally administered as capsules
  • Drug: Placebo
    Orally administered as tablets
    Other Name: LY2157299 monohydrate-matched placebo
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: LY2157299 monohydrate
    • Drug: Lomustine
  • Experimental: LY2157299 monohydrate
    300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)
    Intervention: Drug: LY2157299 monohydrate
  • 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.

    Interventions:
    • Drug: Lomustine
    • Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date July 26, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Poland,   Spain,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01582269
Other Study ID Numbers  ICMJE 13849
H9H-MC-JBAL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date December 1, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP