GlioblastomaPhase 2NCT01582269
A Study in Recurrent Glioblastoma (GB)
A Phase 2 study testing Galunisertib and Lomustine in people with Glioblastoma, run by Eli Lilly and Company at 29 sites in 10 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Galunisertib and Lomustine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 29 sitesin 10 countries
- Study dates
- 26 Apr 2012to 10 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 10 countries.
29 sites in 10 countries
United States5 sites
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
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Cleveland, Ohio, 44195
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Dallas, Texas, 75246
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La Jolla, California, 92093
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San Francisco, California, 94143
France5 sites
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Bobigny, 93009
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Lyon, 69394
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Marseille, 13385
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Nancy, 54035
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Paris, 75651
Germany4 sites
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Bonn, 53105
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Frankfurt, 60596
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Hamburg, 20246
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Heidelberg, 69120
Australia3 sites
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Heidelberg, Victoria, 3084
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065
Belgium3 sites
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Edegem, 2650
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Ghent, 9000
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Liège, 4000
Italy3 sites
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Bologna, 40139
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Terni, 05100
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.
Udine, 33100
Canada2 sites
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.
Montreal, Quebec, H2L 4M1
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Toronto, Ontario, M5G 2M9
Netherlands2 sites
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.
Amsterdam, 1081 HV
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.
Rotterdam, 3075 EA
Poland1 site
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.
Lodz, 93-509
Spain1 site
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.
Barcelona, 08035
About this study
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
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
- Conditions
- Glioblastoma
- Being tested
- Galunisertib, Lomustine, Placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalunisertibDrug
Also called LY2157299 monohydrate
Administered orally
LomustineDrug
Administered orally
PlaceboDrug
Also called Galunisertib-matched Placebo
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Galunisertib; Drug: 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. Receives: Drug: Lomustine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to Date of Death from Any Cause (Up To 20.5 Months)
Secondary outcomes (7)
Progression Free Survival (PFS)
PFS was defined as the time from randomization to the date of the first observation of objective disease progression or death from any cause, whichever occurred first. Participants known to be alive and without disease progression were censored at the date of their last objective progression-free disease assessment prior to the initiation of any subsequent systemic anticancer therapy.
Measured: Randomization to Objective Progression or Death Due to Any Cause (Up To 19 Months)
Percentage of Participants With Tumour Response
Tumour response was assessed using Response Assessment in Neuro-Oncology (RANO) criteria. Responses included Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). CR required disappearance of all enhancing lesions, no new lesions, stable or improved non-enhancing lesions, and no corticosteroid use. PR was defined as ≥50% reduction in enhancing lesion size, no new lesions, stable or improved non-enhancing lesions, and stable or reduced corticosteroid use. SD indicated no significant change in lesion size or clinical status. PD was defined as ≥25% increase in lesion size, new lesions, or clinical deterioration. Percentage of participants with tumor response is defined as the percentage of participants who achieved these tumor responses based on RANO criteria.Participants whose tumor response could not be assessed due to inadequate imaging data were categorized as 'Unknown'.
Measured: 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)
The absorption rate constant (Ka) of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1. A two-compartment model with first-order absorption was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 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. Individual participant Ka values were derived from model-estimated parameters using all available PK timepoints.The reported outcome is the mean of these individual Ka estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Measured: 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)
The Vss at steady state of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1.A two-compartment model was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 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. Individual participant Vss values were derived from model-estimated parameters using all available PK timepoints. The reported outcome is the mean of individual Vss estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Measured: 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)
The apparent clearance (CL/F) of Galunisertib was estimated using PopPK modeling based on plasma concentration-time data collected during Cycle 1. A two-compartment model was applied using nonlinear mixed-effects modeling. Samples were collected at the following time points: Cycle 1 Day 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. Individual participant CL/F values were derived from model-estimated parameters using all available PK timepoints. The reported outcome is the mean of these individual CL/F estimates across both treatment arms (Arm A: Galunisertib; Arm B: Galunisertib + Lomustine).
Measured: 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
Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R)
The Hopkins Verbal Learning Test-Revised comprises:
- 3 Learning Trials: Participants were presented with a list of 12 words (from 3 semantic categories) and were asked to recall them to test verbal learning and memory.
- Delayed Recall Trial: Conducted 20-25 minutes after the 3rd learning trial to test memory retention.
- Delayed Recognition Trial: Participants identified previously presented words from a list that included 12 distractors to test recognition discrimination.
Scoring Components:
- Total Recall Score (0-36): Sum of correctly recalled words across the 3 learning trials.
- Delayed Recall Score (0-12): Number of correct words recalled after the delay.
- Recognition Discrimination Index Score (+12 to -12): Calculated as the number of true positives (correctly identified words) minus false positives (incorrectly identified words, i.e., distractors).
For each of the 3 reported scores, higher scores = better neurocognitive performance; lower scores = decline.
Measured: Baseline, Month 20
Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms)
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It includes:
- 13 core symptoms measuring severity of pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, memory problems, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling, rated 0-10, where 0 = "not present" and 10 = "as bad as you can imagine."
- 9 brain tumor-specific symptoms assess severity of difficulty speaking, weakness, seizures, difficulty understanding, vision changes, appearance changes, bowel pattern changes, concentration problems, and irritability, rated 0-10, where 0 = "not present" and 10 = "as bad as you can imagine."
- 6 interference items assess impact on general activity, mood, work, relations, walking, and enjoyment of life, rated 0-10, where 0 = "did not interfere" and 10 = "interfered completely."
Measured: Baseline, Month 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study start26 Apr 2012
- Primary completion26 Jul 2014
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582269
- Sponsor's protocol ID
- 13849
- Other IDs
- H9H-MC-JBAL, 2011-004418-40
- Status last verified
- Nov 2025
- First submitted
- 19 Apr 2012
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31903699Brandes 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.
PubMed 26902851
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01582269
- Acronym / sponsor ID
- 13849
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2012 (actual)
- Primary completion
- 26 Jul 2014 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Galunisertib | Experimental | Drug: 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. |
| Arm B: Galunisertib + Lomustine | Experimental | Drug: Galunisertib, Drug: 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. |
| Arm C: Lomustine + Placebo | Active comparator | Drug: Lomustine, Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalunisertibAlso: LY2157299 monohydrateAdministered orally | Drug | Arm A: Galunisertib, Arm B: Galunisertib + Lomustine |
| LomustineAdministered orally | Drug | Arm B: Galunisertib + Lomustine, Arm C: Lomustine + Placebo |
| PlaceboAlso: Galunisertib-matched PlaceboAdministered orally | Drug | Arm C: Lomustine + Placebo |
Primary outcome
Overall Survival (OS)
Time frame: Randomization to Date of Death from Any Cause (Up To 20.5 Months)
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.
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: Randomization to Objective Progression or Death Due to Any Cause (Up To 19 Months)
Percentage of Participants With Tumour Response
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Baseline, Month 20
Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms)
Time frame: Baseline, Month 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31903699Smith 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.
- Derived from this study: PubMed 26902851Brandes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galunisertib and Lomustine in people with Glioblastoma, run by Eli Lilly and Company at 29 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Germany, Australia, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Randomization to Date of Death from Any Cause (Up To 20.5 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01582269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.