A Study in Recurrent Glioblastoma (GB) - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Lomustine

Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Population Pharmacokinetics (PK): median population clearance [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ] [ Designated as safety issue: No ]
Progression free survival (PFS) [ Time Frame: Randomization to the date of objective progression or death from any cause estimated up to 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Population Pharmacokinetics (PK): absorption [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ] [ Designated as safety issue: No ]
Population Pharmacokinetics (PK): volume of distribution [ Time Frame: Cycle 1, Day 1, 3, 14, 15 and 16 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	180
Study Start Date:	April 2012
Estimated Study Completion Date:	June 2015
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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01582269 History of Changes
Other Study ID Numbers:	13849, H9H-MC-JBAL
Study First Received:	April 19, 2012
Last Updated:	January 26, 2015
Health Authority:	United States: Food and Drug Administration Australia: National Health and Medical Research Council Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:


Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial	Neuroectodermal Tumors Lomustine Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015