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A Study in Recurrent Glioblastoma (GB)

Primary Purpose

Glioblastoma

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2157299 monohydrate

Lomustine

Placebo

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

LY2157299 monohydrate plus lomustine

LY2157299 monohydrate

lomustine plus placebo

Arm Description

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.

300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Population Pharmacokinetics (PK): median population clearance

Progression free survival (PFS)

Percentage of Participants with Tumor Response

Change from baseline in neurocognitive function

Population Pharmacokinetics (PK): absorption

Population Pharmacokinetics (PK): volume of distribution

Change from baseline in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) score

Full Information

NCT ID

NCT01582269

First Posted

April 19, 2012

Last Updated

October 18, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01582269

Brief Title

A Study in Recurrent Glioblastoma (GB)

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 15, 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 26, 2012 (Actual)

Primary Completion Date

July 26, 2014 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY2157299 monohydrate plus lomustine

Arm Type

Experimental

Arm Description

Arm Title

LY2157299 monohydrate

Arm Type

Experimental

Arm Description

300 mg/day LY2157299, given orally for 14 days, followed by 14 days of rest, equaling a 28-day cycle (unblinded)

Arm Title

lomustine plus placebo

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LY2157299 monohydrate

Other Intervention Name(s)

LY2157299

Intervention Description

Orally administered as tablets

Intervention Type

Drug

Intervention Name(s)

Lomustine

Intervention Description

Orally administered as capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

LY2157299 monohydrate-matched placebo

Intervention Description

Orally administered as tablets

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

Date of randomization to date of death from any cause estimated up to 2 years

Secondary Outcome Measure Information:

Title

Population Pharmacokinetics (PK): median population clearance

Time Frame

Cycle 1, Day 1, 3, 14, 15 and 16

Title

Progression free survival (PFS)

Time Frame

Randomization to the date of objective progression or death from any cause estimated up to 2 years

Title

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

Title

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

Title

Population Pharmacokinetics (PK): absorption

Time Frame

Cycle 1, Day 1, 3, 14, 15 and 16

Title

Population Pharmacokinetics (PK): volume of distribution

Time Frame

Cycle 1, Day 1, 3, 14, 15 and 16

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69394

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Nancy

ZIP/Postal Code

54035

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

31903699

Citation

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.

Results Reference

derived

PubMed Identifier

26902851

Citation

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.

Results Reference

derived

Learn more about this trial

A Study in Recurrent Glioblastoma (GB)

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