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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

158

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2012

Longer than P75 for phase_2

Geographic Reach

10 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.5 years study duration

First Submitted

Initial submission to the registry

April 19, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed

6 days until next milestone

Study Start

First participant enrolled

April 26, 2012

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2014

Completed

10.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2025

Completed

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

April 19, 2012

Results QC Date

October 8, 2025

Last Update Submit

November 12, 2025

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
OS is defined as the time from the date of randomization until death from any cause. For participants not known to have died by the data-inclusion cutoff date, OS is censored at the last date they were known to be alive.
Randomization to Date of Death from Any Cause (Up To 20.5 Months)

Secondary Outcomes (7)

Progression Free Survival (PFS)
Randomization to Objective Progression or Death Due to Any Cause (Up To 19 Months)
Percentage of Participants With Tumour Response
Randomization until measured progressive disease (Up To 19 Months)
Population Pharmacokinetics (PopPK): Absorption Rate Constant of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose
Population Pharmacokinetics (PopPK): Mean Steady State Apparent Volume of Distribution (Vss) of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose
Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine)
Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours (h), 3.5-5 h, and 48 h post-dose; Day 14: Predose, 0.5-2 h, 3.5-5 h, 24 h, and 48 h post last dose
+2 more secondary outcomes

Study Arms (3)

Arm A: Galunisertib

EXPERIMENTAL

* 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.

Drug: Galunisertib

Arm B: Galunisertib + Lomustine

EXPERIMENTAL

* 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.

Drug: GalunisertibDrug: Lomustine

Arm C: Lomustine + Placebo

ACTIVE COMPARATOR

* 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.

Drug: LomustineDrug: Placebo

Interventions

GalunisertibDRUG

Administered orally

Also known as: LY2157299 monohydrate

Arm A: GalunisertibArm B: Galunisertib + Lomustine

LomustineDRUG

Administered orally

Arm B: Galunisertib + LomustineArm C: Lomustine + Placebo

PlaceboDRUG

Administered orally

Also known as: Galunisertib-matched Placebo

Arm C: Lomustine + Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (29)

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, 35294, United States

Location

La Jolla, California, 92093, United States

Location

San Francisco, California, 94143, United States

Location

Cleveland, Ohio, 44195, United States

Location

Dallas, Texas, 75246, United States

Location

St Leonards, New South Wales, 2065, Australia

Location

Heidelberg, Victoria, 3084, Australia

Location

Parkville, Victoria, 3050, Australia

Location

Edegem, 2650, Belgium

Location

Ghent, 9000, Belgium

Location

Liège, 4000, Belgium

Location

Toronto, Ontario, M5G 2M9, Canada

Location

Montreal, Quebec, H2L 4M1, Canada

Location

Bobigny, 93009, France

Location

Lyon, 69394, France

Location

Marseille, 13385, France

Location

Nancy, 54035, France

Location

Paris, 75651, France

Location

Bonn, 53105, Germany

Location

Frankfurt, 60596, Germany

Location

Hamburg, 20246, Germany

Location

Heidelberg, 69120, Germany

Location

Bologna, 40139, Italy

Location

Terni, 05100, Italy

Location

Udine, 33100, Italy

Location

Amsterdam, 1081 HV, Netherlands

Location

Rotterdam, 3075 EA, Netherlands

Location

Lodz, 93-509, Poland

Location

Barcelona, 08035, Spain

Location

Related Publications (2)

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.
PMID: 31903699DERIVED
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.
PMID: 26902851DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

LY-2157299Lomustine

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 20, 2012

Study Start

April 26, 2012

Primary Completion

July 26, 2014

Study Completion

October 10, 2024

Last Updated

November 24, 2025

Results First Posted

November 24, 2025

Record last verified: 2025-11

Locations

BE(3)NL(2)IT(3)AU(3)PL(1)ES(1)US(5)CA(2)FR(5)DE(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

Arm A: Galunisertib

Arm B: Galunisertib + Lomustine

Arm C: Lomustine + Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations