Clinical trial · Interventional
A Study in Recurrent Glioblastoma (GB)
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
NCT01582269CI-TRIAL-00097786completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Galunisertib | Drug | — | UNRESOLVED |
| Lomustine | Drug | Lomustine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Galunisertib
- description
- * 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.
- interventionNames
- Drug: Galunisertib
- type
- EXPERIMENTAL
- label
- Arm B: Galunisertib + Lomustine
- description
- * 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.
- interventionNames
- Drug: Galunisertib
- Drug: Lomustine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSmith 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 31903699
- DERIVEDBrandes 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 26902851